EN 16844:2017+A2:2019
(Main + Amendment)Aesthetic medicine services - Non-surgical medical treatments
Aesthetic medicine services - Non-surgical medical treatments
This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
- treatments with resorbable injectables, botulinum toxin and micro needling;
- treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
- treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
- other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry ) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.
Dienstleistungen in der ästhetischen Medizin - Nicht-chirurgische, medizinische Behandlungen
Diese Europäische Norm legt Anforderungen an bestimmte ästhetische nicht-chirurgische, medizinische Behandlungen fest:
- Behandlungen mit resorbierbaren Injektionsmitteln, Botulinumtoxin und Micro-Needling;
- Behandlungen mit nicht-ablativer fraktionierter Hauterneuerungsbehandlung (Resurfacing) und Oberflächenpeelings, Behandlungen mit Laser und vergleichbaren energiebasierten Geräten;
- Behandlungen mit fraktionierter ablativer Behandlung mit Laser und vergleichbaren energiebasierten Geräten und mitteltiefe Peelings; und
- andere Behandlungen, wie tiefe chemische Peelings, vollständig ablative Laserbehandlungen und Fadenliftings.
Diese Europäische Norm gibt Empfehlungen in Bezug auf ästhetische nicht-chirurgische, medizinische Behandlungen, einschließlich des ethischen Rahmens und allgemeiner Grundsätze, nach denen ästhetische medizinische Dienstleistungen durch alle Ärzte und Interessengruppen im Bereich der ästhetischen Medizin erbracht werden. Diese Empfehlungen gelten vor, während und nach der Behandlung.
Jede ästhetische medizinische Behandlung, die das Gewebe unterhalb der Hornschicht der Haut (Stratum corneum) betrifft, oder die einen biologischen Effekt auf das Gewebe unterhalb der Hornschicht der Haut besitzt (mit oder ohne Instrumente(n) oder Geräte(n)), fällt in den Anwendungsbereich dieser Europäischen Norm.
Ästhetische chirurgische Eingriffe nach EN 16372 und Verfahren der Zahnheilkunde sind aus dem Anwendungsbereich dieser Europäischen Norm ausgeschlossen.
Ästhetische nicht-medizinische Behandlungen (Tätowieren und sämtliche Behandlungen, die nicht das Gewebe unterhalb der Hornschicht der Haut betreffen), die von nichtärztlichen Fachgruppen (z. B. von Tätowierern, Kosmetikern) auf gesetzlich zulässige Weise durchgeführt werden können, sind aus dem Anwendungsbereich dieser Europäischen Norm ausgeschlossen.
Services en médecine esthétique Traitements médicaux, non chirurgicaux
La présente Norme européenne traite des exigences relatives aux prestations de services en médecine esthétique proposées aux patients (traitements médicaux non chirurgicaux).
La présente Norme européenne donne des recommandations en matière de traitements de médecine esthétique non chirurgicaux, y compris un cadre éthique et des principes généraux d’exécution des prestations de services en médecine esthétique par tous les praticiens et parties prenantes de ce domaine. Ces recommandations sont applicables avant, pendant et après le traitement.
Tous les traitements de médecine esthétique qui vont au-delà de la couche cornée ou qui ont ou prétendent avoir un effet biologique au-delà de la couche cornée (avec ou sans instruments ou appareils) sont inclus dans le domaine d'application de la présente Norme européenne. Les traitements de médecine esthétique suivants sont explicitement inclus dans le domaine d'application de la présente Norme européenne :
- traitements de médecine esthétique avec produits d'injection résorbables, toxine botulique et micro-needling ;
- traitements de médecine esthétique avec resurfaçage fractionnel non ablatif, peelings superficiels, lasers et dispositifs médicaux comparables fondés sur l’énergie ;
- traitements de médecine esthétique avec lasers fractionnés ablatifs et dispositifs médicaux comparables fondés sur l’énergie, ainsi que peelings moyens ; et
- autres traitements de médecine esthétique tels que les peelings chimiques profonds, les lasers ablatifs continus, la greffe de cheveux (greffe d’unité folliculaire et extraction d’unité folliculaire) et les fils tenseurs sous-cutanés.
Les actes de chirurgie esthétique traités dans l'EN 16372 et les actes de médecine bucco-dentaire ) sont exclus du domaine d'application de la présente Norme européenne.
Les traitements esthétiques non médicaux (tatouage et traitements dont l'application ne touche pas les tissus au-delà de la couche cornée) qui peuvent être réalisés en toute légalité par des personnes qui ne sont pas médecins (par exemple, tatoueurs, esthéticiens) ne relèvent pas du domaine d'application de la présente Norme européenne.
Storitve estetske medicine - Nekirurški medicinski posegi
Ta evropski standard obravnava zahteve za določene estetske nekirurške medicinske posege:
– posegi z resorpcijskimi snovmi za injiciranje, botulinotoksini in mikrobrizgami;
– posegi z neablativnimi frakcijskimi in površinskimi pilingi ter laserskimi in primerljivimi energijskimi napravami;
– posegi s frakcijskimi ablativnimi laserji in primerljivimi energijskimi napravami ter srednje globokimi pilingi;
– drugi posegi, kot so globoki kemični pilingi, ablativni laserski posegi za celoten obraz in liftingi obraza.
Ta evropski standard določa priporočila za estetske nekirurške medicinske posege, vključno z etičnim okvirjem in splošnimi načeli, v skladu s katerimi vsi izvajalci in zainteresirane strani na področju storitev estetske medicine zagotavljajo te storitve. Ta priporočila se uporabljajo pred in med posegom ter po njem.
Kateri koli estetski medicinski poseg, ki seže globlje od poroženele plasti ali ki (domnevno) ima biološki učinek zunaj poroženele plasti (z instrumenti/pripomočki ali brez njih), spada na področje uporabe tega standarda.
Postopki estetskih medicinskih posegov, ki so opredeljeni v standardu EN 16372, in zobozdravstveni posegi ne spadajo na področje uporabe tega standarda.
Estetski nemedicinski postopki (tetoviranje in kateri koli postopki, ki ne vplivajo na tkivo globlje od rožene plasti), ki jih lahko zakonito izvajajo osebe, ki niso zdravniki (npr. osebe, ki tetovirajo, lepotni terapevti), so zunaj področja uporabe tega evropskega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2019
Nadomešča:
SIST EN 16844:2017+A1:2018
Storitve estetske medicine - Nekirurški medicinski posegi
Aesthetic medicine services - Non-surgical medical treatments
Dienstleistungen in der ästhetischen Medizin - Nicht-chirurgische, medizinische
Behandlungen
Services en médecine esthétique Traitements médicaux, non chirurgicaux
Ta slovenski standard je istoveten z: EN 16844:2017+A2:2019
ICS:
11.020.10 Zdravstvene storitve na Health care services in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 16844:2017+A2
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2019
EUROPÄISCHE NORM
ICS 11.020.10; 03.080.99 Supersedes EN 16844:2017+A1:2018
English Version
Aesthetic medicine services - Non-surgical medical
treatments
Services en médecine esthétique - Traitements Dienstleistungen in der ästhetischen Medizin - Nicht-
médicaux, non chirurgicaux chirurgische, medizinische Behandlungen
This European Standard was approved by CEN on 20 December 2017 and includes Amendment 2 approved by CEN on 16 April
2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 16844:2017+A2:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Terms and definitions . 6
3 Competencies . 8
3.1 General . 8
3.2 Training . 9
3.3 Continuous professional development (CPD) and continuous medical education
(CME) . 9
4 Management and communication with patients . 9
4.1 Office staff/Booking arrangements . 9
4.2 Patient consultation and assessment . 10
4.3 Consent . 11
4.4 Documentation . 12
4.5 Post-treatment follow up and patient satisfaction . 13
4.6 Advertising . 13
4.7 Medical tourism and travelling long distance for treatment . 14
4.8 Medical indemnity and insurance . 15
4.9 Fees . 15
4.10 Arrangements for out of hours and emergency cover . 15
4.11 Complaints . 16
4.12 Confidentiality . 16
4.13 Safe timing of treatments . 16
4.14 Registration . 16
5 Facilities . 16
5.1 Evaluation of compliance and risk management . 16
5.2 Personnel . 16
5.3 Documentation of medical records . 17
5.4 Facility . 17
5.5 Administrative and waiting area . 17
5.6 General requirements and recommendations for treatment rooms and procedure
rooms . 17
5.7 Patient safety and security . 18
5.8 Hygiene standards for treatment rooms and procedure rooms . 19
5.9 Medicines Management . 20
5.10 Treatment room (TR) . 21
5.11 Procedure room (PR) . 21
6 Treatments . 23
6.1 General . 23
6.2 Aesthetic medical treatment categories . 23
6.3 Identifying factors . 23
6.3.1 General . 23
Figure 1 — Relations . 23
6.3.2 Practitioner . 24
6.3.3 Facility . 24
6.3.4 Anaesthesia level . 24
6.3.5 Risk level of treatment . 24
6.3.6 Patient physical status and age . 25
6.3.7 Mental status and patient expectations . 26
6.4 Treatment identification . 26
6.5 Cooling off period . 26
6.6 Aesthetic medical treatments . 26
Annex A (normative) Code of Ethics for marketing and advertising . 29
Annex B (informative) A–deviations . 31
Bibliography . 47
European foreword
This document (EN 16844:2017+A2:2019) has been prepared by Technical Committee CEN/TC 403
“Aesthetic surgery and aesthetic non-surgical medical services”, the secretariat of which is held by
AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2020, and conflicting national standards shall
be withdrawn at the latest by February 2020.
This document includes Amendment 1 approved by CEN on 12 December 2017.
This document includes Amendment 2 approved by CEN on 16 April 2019.
This document supersedes EN 16844:2017+A1:2018.
The start and finish of text introduced or altered by amendment 1 is indicated in the text by tags
! ".
The start and finish of text introduced or altered by amendment 2 is indicated in the text by tags
# $.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Introduction
This European Standard provides a set of requirements, which are deemed to be essential for the
provision of aesthetic medicine services (non-surgical medical treatments).
However, attention is drawn to the fact that in certain countries specific national regulations apply and
take precedence over this European Standard. Users of this European Standard are advised to inform
themselves of the applicability or non-applicability for this European Standard by their national
responsible authorities.
Furthermore, recommendations for other aspects of good practice are provided. The Bibliography
provides a list of European and International Standards and other documents of general interest for
aesthetic medicine services. This list is not intended to be exhaustive.
Emphasis is placed on defining requirements for the quality of the aesthetic medicine services offered in
order to ensure patient safety.
Other factors which influence the overall quality of service include: qualifications and professional
competencies, staff behaviour, facility design and choice of products and suppliers.
This European Standard is designed to bring the following advantages to those that adopt it:
— improvement in aesthetic medicine services which can enhance patient safety and reduce the risk of
complications;
— to promote consistently high standards for aesthetic medicine service providers across Europe;
— enhance patient satisfaction.
Requirements for a quality management system based on EN ISO 9001 for health care services are
provided in EN 15224.
Requirements concerning the occupational health and safety of service providers and their staff at work
are provided in relevant EU-Directives and national occupational health and safety legislation.
1 Scope
This European Standard addresses the requirements for certain aesthetic non-surgical medical
treatments:
— treatments with resorbable injectables, bot
...
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