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93/42/EEC - Medical devices

Council Directive 93/42/EEC of 14 June 1993 establishes harmonized rules for the safety, health protection, and performance of medical devices to ensure their free movement within the European Community. It defines medical devices broadly, including instruments, apparatus, appliances, and accessories intended for human use in diagnosis, treatment, monitoring, or modification of physiological processes. The Directive excludes in vitro diagnostic devices, active implantable devices, medicinal products, and certain human or animal origin materials. Devices are classified into four risk-based categories, with conformity assessment procedures varying accordingly, including manufacturer self-certification for low-risk devices and mandatory notified body involvement for higher-risk classes. The Directive mandates CE marking as evidence of compliance, integrates requirements for electromagnetic compatibility and ionizing radiation emission, and sets out provisions for clinical investigations and vigilance systems. It complements related legislation, such as Directives on medicinal products and active implantable devices, and aligns with standards developed by recognized European standardization bodies to facilitate a high level of protection for patients, users, and third parties while promoting market harmonization and innovation in medical technology.

Purpose

Council Directive 93/42/EEC, adopted on 14 June 1993, aims to harmonize laws concerning medical devices across EU Member States to guarantee a high level of protection for patients, users, and others, while facilitating the free movement of medical devices within the internal market. This Directive establishes common safety, health protection, and performance requirements for medical devices placed on the EU market. It addresses disparities in national laws and certification procedures to remove trade barriers, ensuring that medical devices meet unified standards regarding design, manufacture, and use.

Key Obligations

  • Compliance with Essential Requirements: Medical devices must satisfy essential health and safety requirements outlined in Annex I of the Directive, which consider the technological and practical standards at the time of device design.
  • Conformity Assessment: Devices are classified into classes I, IIa, IIb, and III, reflecting varying risk levels. Higher-risk classes require the involvement of notified bodies for conformity assessment, particularly during design and manufacturing. Class I devices may be self-certified by manufacturers.
  • Manufacturer Responsibilities: The manufacturer, defined broadly to include those responsible for design, packaging, labelling, and assigning intended purposes, must ensure compliance with all requirements and maintain documentation confirming conformity.
  • CE Marking: Devices meeting the Directive’s requirements must bear the CE mark to indicate conformity and permit free circulation within the EU market.
  • Vigilance and Post-Market Surveillance: Manufacturers and Member States must implement monitoring systems to identify and address incidents related to device safety.
  • Clinical Investigations: When necessary to demonstrate compliance, manufacturers may conduct clinical investigations under medical supervision, subject to public health protection rules.
  • Classification and Reclassification Authority: The European Commission is empowered to adjust classification rules and reclassify devices based on technological progress and emerging risks.

Affected Products and Actors

  • Medical Devices and Accessories: The Directive applies to any instrument, apparatus, appliance, material, or other article intended for human use for diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, excluding devices whose principal mode of action is pharmacological, immunological, or metabolic.
  • Accessories: Articles intended by the manufacturer specifically for use with medical devices are treated as devices themselves.
  • Manufacturers: Natural or legal persons responsible for device design, manufacture, packaging, labelling, or assigning intended purposes.
  • Notified Bodies: Independent organizations designated by Member States to conduct conformity assessments based on classification.
  • Excluded Products: In vitro diagnostic devices, active implantable devices (covered under Directive 90/385/EEC), medicinal products, cosmetic products, human blood and related products, transplants/tissues of human or animal origin (with some exceptions), and personal protective equipment covered under other directives are excluded.
  • Products Combining Devices and Medicinal Products: Devices intended to administer medicines are governed primarily by Directive 93/42/EEC, unless the device and medicinal product form a single, non-reusable integral unit, which falls under medicinal product legislation.

Implementation Timeline

  • The Directive was adopted on 14 June 1993.
  • EU Member States were required to transpose and implement the Directive into their national laws by 1995, allowing a transition period to adapt national legislation and enforcement mechanisms.
  • From the date of implementation, all medical devices placed on the EU market must comply with this Directive, including conformity assessment procedures and CE marking requirements.
  • The Directive established ongoing processes for updating classification rules and essential requirements responsive to technological advances and safety concerns, with the Commission empowered to adopt implementing measures under defined decision-making procedures.

This Directive was a cornerstone in EU medical device regulation, later substantially superseded by the Medical Device Regulation (MDR 2017/745), which expanded and strengthened regulatory requirements while maintaining the core objectives of 93/42/EEC.

This Directive applies to medical devices and their accessories intended for use in human beings for various medical purposes including diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, investigation, replacement or modification of anatomy or physiological processes, and control of conception. The Directive covers instruments, apparatuses, appliances, materials, or other articles used alone or in combination, including necessary software. It excludes in vitro diagnostic devices, active implantable devices covered by Directive 90/385/EEC, medicinal products, cosmetic products, human blood and its products, human or animal tissues and cells, and personal protective equipment covered by Directive 89/686/EEC. Devices that administer medicinal products are governed primarily by this Directive unless they form a single integral, non-reusable unit, in which case they fall under medicinal product regulations. The Directive also excludes products primarily governed by other specific EU legislation related to radiation protection and worker safety.

Die Richtlinie 93/42/EWG regelt die Sicherheit und Leistung von Medizinprodukten in der Europäischen Union, um den freien Warenverkehr im Binnenmarkt zu gewährleisten und einen hohen Gesundheitsschutz für Patienten, Anwender und Dritte sicherzustellen. Sie definiert Medizinprodukte sowie deren Zubehör und legt die Anforderungen an deren Auslegung, Herstellung und Inverkehrbringen fest. Dabei berücksichtigt die Richtlinie unterschiedliche Risikoklassen, von Produkten mit geringem Risiko bis zu kritischen Produkten, die strengen Konformitätsbewertungsverfahren unterliegen. Die CE-Kennzeichnung ist Voraussetzung für die Zulassung. Die Richtlinie harmonisiert die Anforderungen unter Berücksichtigung des technischen Fortschritts und ermöglicht eine einheitliche Überwachung der Produkte durch benannte Stellen. Sie schließt bestimmte Produktarten wie Arzneimittel, implantierbare medizinische Geräte oder In-vitro-Diagnostika aus, regelt jedoch Schnittstellen. Zudem enthält sie Vorgaben zur Anwendung von klinischen Prüfungen und beschreibt die Zusammenarbeit zwischen Hersteller, Behörden und benannten Stellen, um die Sicherheit und Wirksamkeit von Medizinprodukten zu gewährleisten. Die Richtlinie fördert somit einen sicheren Binnenmarkt für Medizinprodukte und schützt zugleich die öffentliche Gesundheit.

Zweck

Die Richtlinie 93/42/EWG des Rates vom 14. Juni 1993 über Medizinprodukte hat das Ziel, den Binnenmarkt für Medizinprodukte innerhalb der EU zu harmonisieren und den freien Warenverkehr zu gewährleisten. Unterschiedliche nationale Sicherheits-, Gesundheits- und Leistungsanforderungen sowie verschiedene Zertifizierungs- und Kontrollverfahren in den Mitgliedstaaten stellten bisher Handelshemmnisse dar, die durch diese Richtlinie beseitigt werden sollen.

Medizinprodukte müssen für Patienten, Anwender und gegebenenfalls Dritte ein hohes Schutzniveau bieten und die angegebenen Leistungsmerkmale erfüllen. Die Richtlinie strebt die Aufrechterhaltung oder Verbesserung des Gesundheits- und Sicherheitsstandards an. Sie harmonisiert die Anforderungen an die Auslegung, Herstellung und Prüfung von Medizinprodukten und berücksichtigt dabei den Stand der Technik und Praxis samt technischen und wirtschaftlichen Erwägungen.

Die Richtlinie regelt zudem speziell Produkte, die Arzneimittel abgeben, und behandelt Wechselwirkungen mit anderen relevanten Rechtsvorschriften (z.B. Arzneimittelrichtlinie 65/65/EWG, Richtlinie für aktive implantierbare Medizinprodukte 90/385/EWG).

Wesentliche Verpflichtungen

  • Einhaltung grundlegender Anforderungen: Medizinprodukte müssen die grundlegenden Sicherheits- und Leistungsanforderungen nach Anhang I der Richtlinie erfüllen. Diese umfassen z.B. Schutz der Gesundheit, Sicherheit und elektromagnetische Verträglichkeit.
  • Klassifizierung der Produkte: Medizinprodukte werden in Klassen I, IIa, IIb und III unterteilt, basierend auf ihrem Risiko für den menschlichen Körper und ihre technische Komplexität. Die Klassifizierung bestimmt das geforderte Konformitätsbewertungsverfahren.
  • Konformitätsbewertungsverfahren:
    • Klasse I-Produkte können meist vom Hersteller selbst bewertet und in Verkehr gebracht werden.
    • Für Klasse IIa und IIb-Produkte ist die Einbindung benannter Stellen für bestimmte Prüfphasen verpflichtend.
    • Klasse III-Produkte erfordern strengste Kontrollen inklusive vorheriger behördlicher Zulassung.
  • CE-Kennzeichnung: Medizinprodukte müssen mit der CE-Kennzeichnung versehen sein, die ihre Konformität mit den Vorschriften der Richtlinie belegt.
  • Benannte Stelle und Verantwortlichkeit: Hersteller müssen sicherstellen, dass ihre Produkte konform sind, und ggf. benannte Stellen zur Prüfung einbeziehen. In dringenden Fällen müssen zuständige Behörden eine in der EU ansässige verantwortliche Person für das Produkt benennen können.
  • Klinische Prüfungen: Für bestimmte Medizinprodukte sind klinische Prüfungen vorgeschrieben, die unter der Verantwortung eines qualifizierten Arztes durchgeführt werden.
  • Technische Sicherheitsüberwachung: Es wird ein System zur technischen Überwachung eingerichtet, um den Schutz von Patienten und Anwendern auch nach Markteinführung zu gewährleisten.
  • Harmonisierte Normen: Die Anwendung harmonisierter europäischer Normen zur Verhütung von Risiken wurde gefördert, wobei diese Normen unverbindlich bleiben.

Betroffene Produkte und Akteure

  • Produkte: Die Richtlinie gilt für alle Medizinprodukte und Zubehör, die für Menschen bestimmt sind zur Erkennung, Verhütung, Überwachung, Behandlung oder Linderung von Krankheiten, Verletzungen oder Behinderungen, zur Untersuchung oder Veränderung von Anatomie oder Physiologie oder zur Empfängnisregelung. Zubehör wird dabei als eigenständiges Medizinprodukt behandelt.
  • Ausnahmen:
    • Produkte für In-vitro-Diagnostik,
    • aktive implantierbare medizinische Geräte (Regelung durch Richtlinie 90/385/EWG),
    • Arzneimittel,
    • kosmetische Mittel,
    • menschliches Blut und daraus hergestellte Produkte,
    • Transplantate, Gewebe oder Zellen menschlichen oder tierischen Ursprungs (mit Ausnahmen),
    • persönliche Schutzausrüstungen (regelungsbereichsbezogen).
  • Akteure:
    • Hersteller, die für Auslegung, Herstellung, Verpackung und Kennzeichnung verantwortlich sind,
    • benannte Stellen, die Prüfungen und Zertifizierungen durchführen,
    • zuständige Behörden der Mitgliedstaaten,
    • in der Gemeinschaft niedergelassene verantwortliche Personen im Falle der Herstellerabwesenheit.

Umsetzungszeitplan

Die Richtlinie 93/42/EWG wurde am 14. Juni 1993 erlassen. Die Mitgliedstaaten waren verpflichtet, die Richtlinie binnen einer Übergangsfrist in nationales Recht umzusetzen, um die Konformität von Medizinprodukten mit diesen harmonisierten Anforderungen zu gewährleisten und deren freien Verkehr innerhalb des Binnenmarktes zu ermöglichen.

Konkret mussten die Mitgliedstaaten die notwendigen Rechts- und Verwaltungsvorschriften innerhalb von zwei Jahren nach Veröffentlichung der Richtlinie annehmen. Für Hersteller bedeutete dies insbesondere, dass ab dem Ablauf dieser Frist Medizinprodukte nur noch dann in Verkehr gebracht werden durften, wenn sie mit der Richtlinie konform sind und entsprechend CE-gekennzeichnet wurden.

In der Folge wurden zudem Prüf- und Konformitätsbewertungsverfahren eingeführt, die abhängig von der Risikoklasse der Produkte unterschiedlich gestaltet sind, um einen hohen Gesundheits- und Sicherheitsstandard sicherzustellen. Die Richtlinie stellt die Basis dar, die in späteren Regelwerken (vgl. die Medizinprodukteverordnung – MDR) weiterentwickelt wurde.

Die Richtlinie 93/42/EWG gilt für Medizinprodukte und deren Zubehör, die vom Hersteller zur Anwendung am Menschen bestimmt sind. Dies umfasst Instrumente, Apparate, Vorrichtungen, Stoffe oder andere Gegenstände einschließlich der dafür eingesetzten Software, die für Zwecke wie Erkennung, Verhütung, Überwachung, Behandlung oder Linderung von Krankheiten, Verletzungen oder Behinderungen, Untersuchung, Ersatz oder Veränderung des anatomischen Aufbaus oder eines physiologischen Vorgangs sowie Empfängnisregelung vorgesehen sind. Die mechanistische Hauptwirkung darf dabei nicht pharmakologisch, immunologisch oder metabolisch sein, kann aber durch solche Mittel unterstützt werden. Ausgenommen sind Produkte für die In-vitro-Diagnostik, aktive implantierbare medizinische Geräte, Arzneimittel, kosmetische Mittel, menschliches Blut oder Gewebe menschlichen Ursprungs sowie persönliche Schutzausrüstungen. Zubehör wird als eigenständiges Medizinprodukt behandelt. Die Richtlinie umfasst auch klinische Prüfprodukte und Sonderanfertigungen.

La directive 93/42/CEE établit un cadre harmonisé pour la fabrication, la mise sur le marché et la surveillance des dispositifs médicaux dans l'Union européenne. Elle vise à garantir un niveau élevé de protection de la santé des patients, des utilisateurs et de tiers, tout en assurant la libre circulation de ces dispositifs dans le marché intérieur. Cette directive définit les dispositifs médicaux, y compris leurs accessoires, et établit des exigences essentielles en matière de sécurité, de performances et de compatibilité électromagnétique. Elle introduit une classification des dispositifs en fonction des risques, assortie de procédures d’évaluation de conformité adaptées, impliquant le fabricant et, selon la classe, un organisme notifié. La directive prend en compte les dispositifs combinés contenant des substances susceptibles d’agir comme des médicaments, ainsi que les dispositifs destinés à des investigations cliniques. Elle impose l'apposition du marquage CE attestant de la conformité aux normes communautaires. Enfin, elle encourage le développement de normes européennes harmonisées pour faciliter l’évaluation et le contrôle des dispositifs médicaux, contribuant ainsi à la protection de la santé publique et à l’innovation technologique.

Objet

La directive 93/42/CEE du Conseil, du 14 juin 1993, vise à établir un cadre harmonisé pour la mise sur le marché et la libre circulation des dispositifs médicaux au sein du marché intérieur de l'Union européenne. Elle cherche à garantir un niveau élevé de sécurité et de protection de la santé pour les patients, utilisateurs et tiers en uniformisant les exigences relatives à la conception, à la fabrication, à la certification et au contrôle des dispositifs médicaux.

Obligations clés

  • Sécurité et performances : Les dispositifs médicaux doivent répondre à des exigences essentielles visant à assurer leur sécurité et leur efficacité, incluant la minimisation des risques liés à leur utilisation.
  • Classification des dispositifs : Les dispositifs sont classés en quatre classes (I, IIa, IIb, III) basées sur leur degré de risque pour le patient, afin d’adapter les procédures d’évaluation de conformité.
    • Classe I : faible risque, évaluation sous la seule responsabilité du fabricant.
    • Classe IIa : risque modéré, contrôle obligatoire d’un organisme notifié au stade de fabrication.
    • Classes IIb et III : risques élevés, contrôle obligatoire de l’organisme notifié pour la conception et la fabrication.
  • Évaluation de conformité harmonisée : La directive adopte les modules harmonisés (modules d’évaluation de conformité) qui définissent les responsabilités des fabricants et des organismes notifiés selon la classe de risque du dispositif.
  • Marquage CE : Les dispositifs conformes aux exigences de la directive doivent porter le marquage CE, garantissant leur libre circulation et leur mise en service conformément à leur destination.
  • Dispositifs incorporant des substances à action accessoire : Si un dispositif intègre une substance susceptible d’être un médicament et qui agit par une action accessoire, il est soumis à la directive 93/42/CEE.
  • Investigations cliniques : Les dispositifs destinés aux investigations cliniques doivent respecter certaines conditions visant à protéger la santé publique et l’ordre public.
  • Vigilance : Mise en place de systèmes de vigilance au niveau communautaire pour assurer un suivi et un contrôle continu des dispositifs médicaux une fois commercialisés.
  • Normes harmonisées : Le recours à des normes européennes harmonisées élaborées par le CEN et le CENELEC est encouragé pour démontrer la conformité aux exigences essentielles, ces normes restant volontaires mais bénéficiant d’une présomption de conformité.

Produits et acteurs concernés

  • Dispositifs médicaux : Instruments, appareils, équipements, matières ou autres articles destinés par le fabricant à être utilisés chez l’homme à des fins médicales précises (diagnostic, prévention, traitement, compensation d’un handicap...), y compris les logiciels nécessaires à leur bon fonctionnement.
  • Accessoires des dispositifs : Tout article destiné spécifiquement à être utilisé avec un dispositif médical, considéré comme un dispositif à part entière.
  • Fabricants : Personnes physiques ou morales responsables de la conception, de la fabrication, de l’étiquetage, du conditionnement, et/ou du marquage CE des dispositifs pour leur mise sur le marché.
  • Organismes notifiés : Entités indépendantes chargées de contrôler et d’évaluer la conformité des dispositifs de risque moyen à élevé en fonction des classes de dispositifs.
  • Professionnels de santé et praticiens : Impliqués dans la prescription spécifique de dispositifs sur mesure.
  • Dispositifs incorporant des substances actives : Si la substance agit principalement par action pharmacologique, le dispositif relève alors de la réglementation relative aux médicaments.

Calendrier de mise en œuvre

  • La directive 93/42/CEE entre en vigueur pour garantir une harmonisation progressive des réglementations nationales relatives aux dispositifs médicaux.
  • Les États membres doivent transposer les dispositions de cette directive dans leur droit national dans des délais qui ont été fixés lors de l’adoption (habituellement quelques années à compter de 1993).
  • L’application du marquage CE est obligatoire pour les dispositifs mis sur le marché après l’expiration des périodes de transition nationales.
  • Les fabricants doivent se conformer aux nouvelles règles de classification, d’évaluation de conformité, et aux exigences essentielles définies.
  • La directive a abrogé progressivement certaines directives antérieures (notamment sur les thermomètres médicaux à mercure et les appareils électriques médicaux).
  • Des mécanismes d’adaptation sont prévus pour suivre les évolutions technologiques et intégrer des modifications, sous contrôle de la Commission européenne.

La directive 93/42/CEE s'applique aux dispositifs médicaux et à leurs accessoires. Un dispositif médical est défini comme tout instrument, appareil, équipement, matière ou autre article, utilisé seul ou en association, y compris le logiciel nécessaire à son fonctionnement, destiné par le fabricant à être utilisé chez l'humain à des fins de diagnostic, prévention, contrôle, traitement ou atténuation d'une maladie, d'une blessure ou d'un handicap, d'étude ou de modification de l'anatomie ou d'un processus physiologique, ou de maîtrise de la conception. L'action principale voulue du dispositif ne doit pas être obtenue par des moyens pharmacologiques ou immunologiques. La directive couvre également les dispositifs incorporant des substances susceptibles d'être considérées comme des médicaments, dans la mesure où l'action de ces substances est accessoire à celle du dispositif. Les dispositifs destinés à l'administration de médicaments sont régis par cette directive sauf s'ils forment un produit intégré non réutilisable avec un médicament.

Direktiva 93/42/EGS ureja medicinske pripomočke z namenom zagotavljanja visoke ravni varnosti in učinkovitosti na notranjem trgu Evropske unije. Opredeljuje medicinski pripomoček kot instrument, napravo, material ali drug predmet, vključno s programsko opremo, namenjen za uporabo na ljudeh za diagnozo, zdravljenje, lajšanje bolezni, nadzor spočetja ali spremembo anatomije ali fizioloških procesov, pri čemer učinek ni dosežen s farmakološkimi, imunološkimi ali presnovnimi sredstvi. Direktiva določa razredifikacijo medicinskih pripomočkov glede na tveganje ter zahteva označevanje CE kot znak skladnosti z bistvenimi zahtevami glede varnosti in učinkovitosti. Uveljavlja postopke ocenjevanja skladnosti, ki vključujejo sodelovanje proizvajalcev in pooblaščenih organov, ter določa obveznosti glede postavitve, vzdrževanja in uporabe pripomočkov. Namen direktive je uskladiti nacionalne predpise, odpraviti ovire za trgovanje in zagotoviti enotno raven zaščite zdravja bolnikov, uporabnikov in drugih oseb v Evropski uniji. Izjeme se nanašajo na določene izdelke, kot so diagnostični pripomočki in zdravila, urejena z drugimi direktivami.

Namen

Direktiva Sveta 93/42/EGS z dne 14. junija 1993 ureja medicinske pripomočke z namenom vzpostavitve enotnih zahtev za dajanje teh pripomočkov na notranji trg Evropske unije. Glavni namen direktive je zagotoviti visoko raven varnosti in zdravstvenega varstva pacientov, uporabnikov in drugih oseb ter omogočiti prosti pretok medicinskih pripomočkov znotraj notranjega trga EU. Direktiva določa enotne bistvene zahteve glede varnosti, zmogljivostnih lastnosti, označevanja in postopkov ocenjevanja skladnosti. Ta pravila so vzpostavljena za odpravo ovir v trgovini med državami članicami zaradi različnih nacionalnih zakonodaj.

Ključne obveznosti

  • Izpolnjevanje bistvenih zahtev: Medicinski pripomoček mora izpolnjevati bistvene zahteve varnosti in zmogljivosti iz Priloge I direktive, ob upoštevanju njegovega predvidenega namena.
  • Postopki ocenjevanja skladnosti: Proizvajalci morajo zagotoviti ustrezno vrednotenje in dokumentacijo, s katero dokažejo skladnost z direktivo. Postopki ocenjevanja so prilagojeni stopnji tveganja, razvrščeni v štiri razrede (I, IIa, IIb, III). Višji razredi zahtevajo večji nadzor s strani priglašenih organov.
  • Označevanje CE: Medicinski pripomočki morajo imeti oznako CE, ki potrjuje, da izdelek ustreza zahtevam direktive in je zato dovoljeno njegovo dajanje na trg ter dajanje v uporabo znotraj skupnosti.
  • Izjava o skladnosti: Proizvajalci morajo izdelati in hraniti tehnično dokumentacijo ter izjava o skladnosti, ki potrjuje skladnost izdelka.
  • Posebni pripomočki: Uporabniku prilagojeni pripomočki in pripomočki za klinične preiskave morajo izpolnjevati določene posebne pogoje, vključno z zahtevami po spremljajoči izjavi skladnosti.
  • Jezik informacij: Države članice lahko zahtevajo, da so informacije uporabnikom in bolnikom na voljo v nacionalnem jeziku ali drugem jeziku EU.
  • Klinične preiskave: Če je potrebna potrditvena klinična preiskava, jo mora proizvajalec izvesti ob upoštevanju zaščite javnega zdravja.

Zadevni izdelki in akterji

  • Medicinski pripomočki: Vsak instrument, naprava, aparat, material ali drug predmet (vključno s programsko opremo), ki je namenjen za uporabo pri ljudeh za diagnostiko, zdravljenje, nadzorovanje, preprečevanje bolezni ali nadomeščanje anatomskih/physioloških funkcij.
  • Dodatki: Predmeti, namenjeni uporabi skupaj z medicinskimi pripomočki za doseganje njihovega namena.
  • Izključeni proizvodi: Iz direktive so izključeni in vitro diagnostični pripomočki, aktivni pripomočki za vsaditev (urejeni z Direktivo 90/385/EGS), zdravila, kozmetični izdelki, krvni izdelki in organi, osebna zaščitna oprema ter določeni pripomočki iz živalskih tkiv.
  • Proizvajalci: Fizične ali pravne osebe, odgovorne za načrtovanje, izdelavo, pakiranje in označevanje izdelkov z namenom njihovega data na trg pod lastnim imenom. Tudi osebe, ki sestavljajo ali prenovijo medicinske pripomočke, so odgovorne.
  • Priglašeni organi: Neodvisne organizacije, pristojne za ocenjevanje skladnosti izdelkov, še posebej pri višjih razredih tveganja.

Roki izvajanja

Direktiva 93/42/EGS je začela veljati takoj po njeni objavi in je bila predpisana za implementacijo v nacionalnih zakonodajah držav članic EU. Države članice so morale sprejeti potrebne nacionalne ukrepe, s katerimi so zagotovile skladnost zakonodaje z zahtevami direktive v predpisanih rokih, ki so bili določeni neposredno v direktivi in v splošnih določbah za tehnične direktive. S tem je bil omogočen prosti pretok medicinskih pripomočkov na notranjem trgu EU brez administrativnih ovir.

Ta direktiva se je kasneje nadgradila in dopolnila s številnimi drugimi predpisi, vključno z Uredbo o medicinskih pripomočkih (MDR 2017/745), ki je postopoma nadomestila direktivo in uvedla strožje zahteve za varnost in nadzor medicinskih pripomočkov v EU.

Direktiva 93/42/EGS se uporablja za medicinske pripomočke in njihove dodatke, ki jih proizvajalec namenja za uporabo na ljudeh z namenom diagnostike, preprečevanja, spremljanja, zdravljenja ali lajšanja bolezni, poškodb ali okvar, spreminjanja anatomije ali fizioloških procesov ter nadzora spočetja. Med medicinske pripomočke spadajo instrumenti, aparati, naprave, materiali ali drugi predmeti, vključno s programsko opremo, ki je potrebna za njihovo pravilno uporabo. Direktiva ne velja za diagnostične pripomočke za in vitro diagnostiko, aktivne pripomočke za vsaditev urejene po drugi direktivi, zdravila, kozmetične izdelke, človeško kri in njene izdelke, presaditvene organe ali tkiva ljudskega in živalskega izvora (z nekaterimi izjemami) ter opremo za osebno zaščito, ki jo ureja posebna direktiva. Uporaba direktive se osredotoča na medicinske pripomočke namenjene ljudi, ki ne dosegajo svojega glavnega učinka s farmakološkimi, imunološkimi ali presnovnimi sredstvi, čeprav so jim lahko ta sredstva pri delovanju v pomoč.

General Information

Type
Directive
Category
Main
Force Date
31-Dec-1994
Transitional Period Date
13-Jun-1998
Official Journal Reference
L 169
Official Journal Date
11-Jul-1993
New Approach Directive
Yes
CELEX Number
31993L0042
ELI URI
http://data.europa.eu/eli/dir/1993/42/oj
In Force
No
Entry into Force
29-Jun-1993
End of Validity
25-May-2021

Related Mandates

M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/342 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: hyperbaric chambers for medical purposes)
M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
M/433 - Standardisation mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC, amending Directive 93/42/EEC relating to Medical Devices, concerning graphical symbols for use in the labelling of medical devices containing phthalates
M/467 - Standardisation mandate addressed to CEN and CENELEC: modification and completion of EN 60601-2-52 to prevent entrapment of children and of adults with an atypical anatomy in medical beds and entrapment of children in medical cots
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
M/BC/CEN/91/3 - Condoms

Related Directives

Amends: 90/385/EEC - Active implantable medical devices
Standardization Organization
ICS
Technical Committee
Mandate
50
SIST
SIST EN ISO 18777-1:2026(Main)
Transportable liquid oxygen systems for medical use - Part 1: Common requirements and particular requirements for base units (ISO 18777-1:2026)
EN ISO 18777-1:2026

This document specifies requirements for transportable liquid oxygen systems that are common to both base units and portable units and requirements that are particular to base units.
Stationary liquid oxygen systems used for oxygen pipeline supply systems are excluded from this document.
NOTE 1        Throughout this document the term “units” is used where the requirement applies to both base units and portable units.
NOTE 2        ISO 18777 - 2 specifies those requirements particular to portable units.

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CEN
EN ISO 18777-1:2026(Main)
Transportable liquid oxygen systems for medical use - Part 1: Common requirements and particular requirements for base units (ISO 18777-1:2026)
SIST EN ISO 18777-1:2026

This document specifies requirements for transportable liquid oxygen systems that are common to both base units and portable units and requirements that are particular to base units.
Stationary liquid oxygen systems used for oxygen pipeline supply systems are excluded from this document.
NOTE 1        Throughout this document the term “units” is used where the requirement applies to both base units and portable units.
NOTE 2        ISO 18777 - 2 specifies those requirements particular to portable units.

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SIST
SIST EN IEC 62083:2026(Main)
Medical device software - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2025)
EN IEC 62083:2026

IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system.
This document applies to the communication of the radiotherapy treatment planning system with other devices
– used in medical practice,
– that imports data either through input by the operator or from other devices,
– that outputs data to other devices, and
– that is intended to be
- for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training,
- used and maintained in accordance with the recommendations given in the instructions for use, and
– used within the environmental conditions specified in the technical description.
This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system.
IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
– modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems;
– Adaptive radiotherapy is added with Clause 16;
– The title reflects different implementations of radiotherapy treatment planning systems.

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    62 pages
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SIST
SIST EN IEC 60601-2-57:2026(Main)
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
EN IEC 60601-2-57:2026

IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).

  • Standard
    31 pages
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SIST
SIST EN IEC 60601-2-64:2026(Main)
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment (IEC 60601-2-64:2025)
EN IEC 60601-2-64:2026

IEC 60601-2-64:2025 applies to the BASIC SAFETY and essential performance of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of patients. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.

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EN IEC 62083:2026(Main)
Medical device software - Requirements for the safety of radiotherapy treatment planning systems
SIST EN IEC 62083:2026

IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system. This document applies to the communication of the radiotherapy treatment planning system with other devices – used in medical practice, – that imports data either through input by the operator or from other devices, – that outputs data to other devices, and – that is intended to be - for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training, - used and maintained in accordance with the recommendations given in the instructions for use, and – used within the environmental conditions specified in the technical description. This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system. IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: – modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems; – Adaptive radiotherapy is added with Clause 16; – The title reflects different implementations of radiotherapy treatment planning systems.

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EN IEC 60601-2-64:2026(Main)
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
SIST EN IEC 60601-2-64:2026

IEC 60601-2-64:2025 applies to the BASIC SAFETY and essential performance of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of patients. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified installation aspects of LIGHT ION BEAM ME EQUIPMENT – intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n, and – intended to be • for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020; b) harmonization with IEC 62667:2017 for defined terms and definitions; c) address revision to neutrons outside the field of irradiation.

  • Standard
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EN IEC 60601-2-57:2026(Main)
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
SIST EN IEC 60601-2-57:2026

IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).

  • Standard
    31 pages
    English language
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SIST
SIST EN ISO 18777-2:2026(Main)
Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO 18777-2:2025)
EN ISO 18777-2:2025

This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE            Requirements that are common to both portable units and base units are specified in ISO 18777-1.

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SIST
SIST EN IEC 62570:2026(Main)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2025)
EN IEC 62570:2025

IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.

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EN IEC 62570:2025(Main)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
SIST EN IEC 62570:2026

IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment. This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling. MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.

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CEN
EN ISO 18777-2:2025(Main)
Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO 18777-2:2025)
SIST EN ISO 18777-2:2026

This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE            Requirements that are common to both portable units and base units are specified in ISO 18777-1.

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SIST
SIST EN 455-5:2025(Main)
Medical gloves for single use - Part 5: Extractable chemical residues
EN 455-5:2025

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.

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EN 455-5:2025(Main)
Medical gloves for single use - Part 5: Extractable chemical residues
SIST EN 455-5:2025

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.

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SIST
SIST EN ISO 4823:2025(Main)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2025)
EN ISO 4823:2025

This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.

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EN ISO 4823:2025(Main)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2025, Corrected version 2025-08)
SIST EN ISO 4823:2025

This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.

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SIST
SIST EN IEC 60601-2-83:2020/A1:2025(Amendment)
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (IEC 60601-2-83:2019/AMD1:2022)
EN IEC 60601-2-83:2020/A1:2025

2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes

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EN IEC 60601-2-83:2020/A1:2025(Amendment)
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
SIST EN IEC 60601-2-83:2020/A1:2025

2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes

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SIST
SIST EN IEC 60601-2-68:2025(Amendment)
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment (IEC 60601-2-68:2025)
EN IEC 60601-2-68:2025

IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be:
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 80601-2-68:2024 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new editions of the relevant standards:
– IEC 60601-2-1:2020;
– IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016;
– IEC 60601-2-64:2014;
b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE);
c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.

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EN IEC 60601-2-68:2025(Main)
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
SIST EN IEC 60601-2-68:2025

IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT. This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be: • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. IEC 80601-2-68:2024 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with the new editions of the relevant standards: – IEC 60601-2-1:2020; – IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016; – IEC 60601-2-64:2014; b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE); c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.

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SIST
SIST EN ISO 10993-5:2009/A11:2025(Amendment)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
EN ISO 10993-5:2009/A11:2025
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    6 pages
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CEN
EN ISO 10993-5:2009/A11:2025(Amendment)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
SIST EN ISO 10993-5:2009/A11:2025
  • Amendment
    6 pages
    English language
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SIST
SIST EN IEC 60601-2-34:2025(Main)
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (IEC 60601-2-34:2024)
EN IEC 60601-2-34:2024

IEC 60601-2-34:2024 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT.
This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT.
This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME.
This document does not apply to non-invasive blood pressure monitoring equipment.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows:
The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM.
IEC 60601-2-34:2024 cancels and replaces the third edition of IEC 60601-2-34 published in 2011 and constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, as well as new versions of collateral standards and amendments thereto;
b) expansion of the scope to the emergency medical service environment;
c) changed essential performance in Table 201.101;
d) changed requirement for ingress protection;
e) added primary operating functions;
f) deleted Annex BB Alarm diagrams.

  • Standard
    65 pages
    English language
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EN IEC 60601-2-34:2024(Main)
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
SIST EN IEC 60601-2-34:2025

IEC 60601-2-34:2024 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT. This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT. This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME. This document does not apply to non-invasive blood pressure monitoring equipment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows: The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM. IEC 60601-2-34:2024 cancels and replaces the third edition of IEC 60601-2-34 published in 2011 and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, as well as new versions of collateral standards and amendments thereto; b) expansion of the scope to the emergency medical service environment; c) changed essential performance in Table 201.101; d) changed requirement for ingress protection; e) added primary operating functions; f) deleted Annex BB Alarm diagrams.

  • Standard
    65 pages
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SIST
SIST EN IEC 60601-2-37:2025(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2024)
EN IEC 60601-2-37:2024

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx,
b) technical and editorial changes as a result of maintenance to normative references;
c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

  • Standard
    63 pages
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EN IEC 60601-2-37:2024(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
SIST EN IEC 60601-2-37:2025

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

  • Standard
    63 pages
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SIST
SIST EN IEC 80601-2-58:2024(Main)
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2024)
EN IEC 80601-2-58:2024

IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005.
IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards;
c) updated normative references;
d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101;
e) adding the shadow light method in 201.12.1.101.7;
f) clarify test conditions for EMC requirements in 202.7.1.2;
g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”;
h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB);
i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.

  • Standard
    43 pages
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SIST
SIST EN IEC 60601-2-54:2024(Main)
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2022)
EN IEC 60601-2-54:2024

IEC 60601-2-54:2022 is available as IEC 60601-2-54:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3;
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017;
e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.

  • Standard
    83 pages
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SIST
SIST EN IEC 60601-2-33:2024(Main)
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2022)
EN IEC 60601-2-33:2024

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.
NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS.
This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MR EQUIPMENT and to MR SYSTEMS, as relevant.
This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.

  • Standard
    150 pages
    English language
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    1 day
SIST
SIST EN 60601-2-45:2011/A2:2024(Amendment)
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011/A2:2022)
EN 60601-2-45:2011/A2:2024
  • Amendment
    13 pages
    English language
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    1 day
CLC
EN 60601-2-10:2015/A2:2024(Amendment)
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
SIST EN 60601-2-10:2015/A2:2024
  • Amendment
    8 pages
    English language
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    1 day
CLC
EN 60601-2-6:2015/A2:2024(Amendment)
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
SIST EN 60601-2-6:2015/A2:2024
  • Amendment
    7 pages
    English language
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    1 day
CLC
EN 60601-2-45:2011/A2:2024(Amendment)
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
SIST EN 60601-2-45:2011/A2:2024
  • Amendment
    13 pages
    English language
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    1 day
CLC
EN IEC 60601-2-33:2024(Main)
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
SIST EN IEC 60601-2-33:2024

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS. NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS. This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MR EQUIPMENT and to MR SYSTEMS, as relevant. This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.

  • Standard
    150 pages
    English language
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    1 day
CLC
EN IEC 80601-2-58:2024(Main)
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
SIST EN IEC 80601-2-58:2024

IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.

  • Standard
    43 pages
    English language
    e-Library read for
    1 day
CLC
EN 60601-2-3:2015/A2:2024(Amendment)
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
SIST EN 60601-2-3:2015/A2:2024
  • Amendment
    7 pages
    English language
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EN IEC 60601-2-54:2024(Main)
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
SIST EN IEC 60601-2-54:2024

IEC 60601-2-54:2022 is available as IEC 60601-2-54:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows: a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER; b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3; c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares; d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017; e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT; f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.

  • Standard
    83 pages
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    1 day
SIST
SIST EN IEC 61674:2024(Main)
Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging (IEC 61674:2024)
EN IEC 61674:2024

IEC 61674:2024 specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as RADIOGRAPHY, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-RADIATION with generating potentials in the range of 20 kV to 150 kV. This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.
IEC 61674:2024 cancels and replaces the second edition published in 2012. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION QUALITY;
b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION QUALITIES for the compliance test on energy dependence of response;
c) the compliance test for analogue displays was removed;
d) the compliance tests for range reset, the effect of leakage and recombination losses were removed. These tests are already covered by the test on linearity and cannot be conducted for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed accordingly;
e) the compliance test for mains rechargeable and battery-operated dosimeters were updated for modern devices

  • Standard
    39 pages
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EN IEC 61674:2024(Main)
Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
SIST EN IEC 61674:2024

IEC 61674:2024 specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as RADIOGRAPHY, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-RADIATION with generating potentials in the range of 20 kV to 150 kV. This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging. IEC 61674:2024 cancels and replaces the second edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION QUALITY; b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION QUALITIES for the compliance test on energy dependence of response; c) the compliance test for analogue displays was removed; d) the compliance tests for range reset, the effect of leakage and recombination losses were removed. These tests are already covered by the test on linearity and cannot be conducted for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed accordingly; e) the compliance test for mains rechargeable and battery-operated dosimeters were updated for modern devices

  • Standard
    39 pages
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    1 day
SIST
SIST EN 17854:2024(Main)
Antimicrobial wound dressings - Requirements and test method
EN 17854:2024

This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.

  • Standard
    47 pages
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CEN
EN 17854:2024(Main)
Antimicrobial wound dressings - Requirements and test method
SIST EN 17854:2024

This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.

  • Standard
    47 pages
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SIST
SIST EN 1789:2020+A1:2024(Main)
Medical vehicles and their equipment - Road ambulances
EN 1789:2020+A1:2023

This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport, monitoring, treatment and care of patients. It contains requirements for the patient’s compartment in terms of the working environment, ergonomic design and the safety of the crew and patients.This European Standard does not cover the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.
This European Standard is applicable to road ambulances capable of transporting at least one person on a stretcher and excludes the transportation of hospital beds.
This standard also specifies requirements for ambulances intended to carry transport incubator systems.
The European Standard covers the specific requirements of each type of road ambulance which are
designated according to the patient condition e.g. patient transport road ambulance types A1, A2, B and C.
This European Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.

  • Standard
    58 pages
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SIST
SIST EN ISO 10993-18:2020(Main)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO 10993-18:2020

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
—          the identification of its materials of construction (medical device configuration);
—          the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
—          the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
—          the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
—          the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

  • Standard
    81 pages
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SIST
SIST EN ISO 11137-2:2015/A1:2023(Amendment)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
EN ISO 11137-2:2015/A1:2023

2022-06-21 - lack of compliance - publication on hold

  • Amendment
    13 pages
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SIST
SIST EN ISO 10993-15:2023(Main)
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
EN ISO 10993-15:2023

This document specifies general requirements for the design of tests for identifying and quantifying
degradation products from final metallic medical devices or corresponding material samples finished
as ready for clinical use.
This document is applicable only to those degradation products generated by chemical alteration of the
final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results
approximate the in vivo behaviour of the implant or material. The described chemical methodologies
are a means to generate degradation products for further assessments.
This document is applicable to both materials designed to degrade in the body as well as materials that
are not intended to degrade.
This document is not applicable to evaluation of degradation which occurs by purely mechanical
processes; methodologies for the production of this type of degradation product are described in
specific product standards, where available.
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the
scope of this document, such degradation products can evoke a biological response and can undergo biological
evaluation as described in other parts of ISO 10993.
Because of the wide range of metallic materials used in medical devices, no specific analytical
techniques are identified for quantifying the degradation products. The identification of trace elements
(<10–6 w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific
requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable
clauses of ISO 10993-1 and ISO 10993-17).

  • Standard
    26 pages
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SIST
SIST EN IEC 61676:2023(Main)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2023)
EN IEC 61676:2023

IEC 61676:2023 is available as IEC 61676:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".

  • Standard
    37 pages
    English language
    e-Library read for
    1 day
CLC
EN IEC 61676:2023(Main)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
SIST EN IEC 61676:2023

IEC 61676:2023 is available as IEC 61676:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".

  • Standard
    37 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-10:2023(Main)
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
EN ISO 10993-10:2023

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
—    details of in vivo skin sensitization test procedures;
—    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

  • Standard
    60 pages
    English language
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SIST
SIST EN IEC 80601-2-59:2019/A1:2023(Amendment)
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 80601-2-59:2017/AMD1:2023)
EN IEC 80601-2-59:2019/A1:2023

20211012-JO-Link to 93/42/EEC and M/295 removed

  • Amendment
    9 pages
    English language
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    1 day
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EN IEC 80601-2-59:2019/A1:2023(Amendment)
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
SIST EN IEC 80601-2-59:2019/A1:2023

20211012-JO-Link to 93/42/EEC and M/295 removed

  • Amendment
    9 pages
    English language
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Frequently Asked Questions

An EU Directive is a legislative act of the European Union that sets out goals that all EU member states must achieve. However, it is up to each member state to devise their own laws on how to reach these goals through national transposition. Directives are used to harmonize laws across the EU, particularly for the functioning of the single market.

Directive 93/42/EEC covers "Medical devices". There are 2776 standards associated with this directive.

Harmonized standards under 93/42/EEC are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 93/42/EEC, facilitating CE marking and free movement within the European Economic Area.