SIST EN 556-1:2024
(Main)Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden
Dieses Dokument legt die Anforderungen an ein in der Endpackung sterilisiertes Medizinprodukt fest, das als „STERIL“ gekennzeichnet wird. Teil 2 dieser Europäischen Norm legt die Anforderungen an ein aseptisch hergestelltes Medizinprodukt fest, das als „STERIL“ gekennzeichnet wird.
ANMERKUNG Für die Anwendung der EU-Richtlinie(n) für Medizinprodukte (siehe Literaturhinweise) ist die Kennzeichnung eines Medizinproduktes als „STERIL“ nur gestattet, wenn ein validiertes Sterilisationsverfahren angewandt wurde. Anforderungen an die Validierung und die Routineüberwachung von Sterilisationsverfahren für Medizinprodukte sind EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665 1, EN ISO 20857, EN ISO 25424 und ISO 22441 angegeben.
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage « STÉRILE » - Partie 1 : Exigences relatives aux dispositifs médicaux stérilisés de façon terminale
Le présent document spécifie les exigences à satisfaire pour qu’un dispositif médical stérilisé de façon terminale puisse être étiqueté « STÉRILE ». La partie 2 de l’EN 566 spécifie les exigences à satisfaire pour qu’un dispositif médical soumis à un traitement aseptique puisse être étiqueté « STÉRILE ».
Sterilizacija medicinskih pripomočkov - Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" - 1. del: Zahteve za končno sterilizirane medicinske pripomočke
Ta dokument določa zahteve za končno sterilizirane medicinske pripomočke, ki morajo biti označeni s »STERILNO«. 2. del tega evropskega standarda določa zahteve za medicinske pripomočke, izdelane v aseptičnem okolju, z oznako »STERILNO«.
OPOMBA: Za namen tega standarda se uporabljajo direktive Evropske unije za medicinske pripomočke (glej razdelek Literatura), ki določajo, da je uporaba oznake »STERILNO« za medicinski pripomoček dovoljena samo na podlagi potrjenega postopka sterilizacije. Zahteve za potrjevanje in rutinsko kontrolo postopkov sterilizacije medicinskih pripomočkov so določene v standardih EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 in ISO 22441.
General Information
Relations
Overview
EN 556-1:2024 - "Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices" (CEN) defines the conditions under which a medical device can be labelled STERILE when sterilization is performed in the final/terminal packaging. It updates definitions (aligned with EN ISO 11139), replaces earlier annexes to map to EU Regulations, and clarifies the documentation and evidence required to demonstrate that devices meet sterility requirements.
Key topics and requirements
- Sterility assurance level (SAL): For a device to be designated STERILE, the probability of a single viable microorganism on/in the device after sterilization shall be ≤ 1 × 10⁻⁶ (SAL 10⁻⁶). Regulatory permission may be sought for a different SAL in specific cases.
- Validated sterilization process: Designation as “STERILE” is only permissible when a sterilization process has been validated and is subject to routine control and monitoring.
- Documentation and records: Manufacturers must retain validation records and routine control evidence in accordance with EN ISO 13485 (quality management) to demonstrate compliance.
- Definitions and scope: Key terms defined include bioburden, sterility, sterile, SAL, and terminally sterilized (device exposed to a sterilization process in its sterile barrier system).
- Regulatory alignment: Informative annexes (ZA and ZB) show correspondence with the General Safety and Performance Requirements of Regulation (EU) 2017/745 (medical devices) and 2017/746 (IVDs).
- Risk-based considerations: The standard recognizes risk-based approaches (e.g., ISO/TS 19930 guidance) for selecting an appropriate SAL when products cannot tolerate processes to achieve SAL 10⁻⁶.
Applications and who uses it
- Medical device manufacturers - to justify labelling devices as STERILE and to support technical files for regulatory submissions.
- Sterilization validation engineers and contract sterilization providers - to design, validate, and document terminal sterilization processes.
- Quality and regulatory affairs teams - to ensure records meet EN ISO 13485 retention requirements and EU regulatory expectations.
- Notified bodies and auditors - to assess conformity with sterility claims and related process controls.
- Clinical procurement and hospital sterilization services - for understanding sterilization claims on packaged devices.
Related standards (applicable)
This part references and should be used with sterilization process standards and validation guidance such as:
- EN ISO 13485 (QMS)
- EN ISO 11135, EN ISO 11137, EN ISO 17665-1, EN ISO 14937, EN ISO 14160, EN ISO 20857, EN ISO 25424, ISO 22441
- EN ISO 11139 (terminology)
Using EN 556-1:2024 together with these standards helps ensure robust sterilization validation, routine control, and regulatory compliance for terminally sterilized medical devices.
Frequently Asked Questions
SIST EN 556-1:2024 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices". This standard covers: This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
SIST EN 556-1:2024 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 556-1:2024 has the following relationships with other standards: It is inter standard links to SIST EN 556-1:2002/AC:2006, SIST EN 556-1:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 556-1:2024 is associated with the following European legislation: EU Directives/Regulations: 2017/745, 2017/746, EUR-PUB; Standardization Mandates: M/575, M/575 AMD 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN 556-1:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Nadomešča:
SIST EN 556-1:2002/AC:2006
Sterilizacija medicinskih pripomočkov - Zahteve za medicinske pripomočke, ki
morajo biti označeni s "STERILNO" - 1. del: Zahteve za končno sterilizirane
medicinske pripomočke
Sterilization of medical devices - Requirements for medical devices to be designated
"STERILE" - Part 1: Requirements for terminally sterilized medical devices
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als
"STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der
Endpackung sterilisiert wurden
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en
vue d'obtenir l'étiquetage « STÉRILE » - Partie 1 : Exigences relatives aux dispositifs
médicaux stérilisés de façon terminale
Ta slovenski standard je istoveten z: EN 556-1:2024
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 556-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN 556-1:2001
English Version
Sterilization of medical devices - Requirements for medical
devices to be designated "STERILE" - Part 1: Requirements
for terminally sterilized medical devices
Stérilisation des dispositifs médicaux - Exigences Sterilisation von Medizinprodukten - Anforderungen
relatives aux dispositifs médicaux en vue d'obtenir an Medizinprodukte, die als "STERIL" gekennzeichnet
l'étiquetage " STÉRILE " - Partie 1 : Exigences relatives werden - Teil 1: Anforderungen an Medizinprodukte,
aux dispositifs médicaux stérilisés de façon terminale die in der Endpackung sterilisiert wurden
This European Standard was approved by CEN on 19 May 2024.
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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 556-1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirements . 7
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 8
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 11
Bibliography . 13
European foreword
This document (EN 556-1:2024) has been prepared by Technical Committee CEN/TC 204, Sterilization of
medical devices, the secretariat of which is held by BSI.
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 January 2025, and conflicting national standards shall be withdrawn
at the latest by January 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 556-1:2001 and EN 556-1:2001/AC:2006.
This document has been prepared under a Standardization Request given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s) /
Regulation(s). For relationship with EU Directive(s) / Regulation(s), see informative Annexes ZA and ZB,
which is an integral part of this document.
EN 556, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE”, is
currently composed with the following parts:
— Part 1: Requirements for terminally sterilized medical devices [this document];
— Part 2: Requirements for aseptically processed medical devices.
EN 556-1:2001/AC:2006:
— definitions have been aligned with EN ISO 11139;
— the normative reference has been updated to the latest edition;
— informative Annex ZA has been replaced with informative Annexes ZA and ZB giving the relationship with
the European Regulations for medical devices and in vitro diagnostic medical devices respectively;
— the Bibliography has been updated.
Any feedback and questions on this document should be directed to the users’ national standards body. A
complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations 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, Türkiye and the United Kingdom.
Introduction
A sterile product item is one which is free of viable microorganisms. European standards for medical devices
require, when it is necessary to supply a sterile product item, that adventitious microbiological contamination
of a medical device from all sources is minimized by all practical means. Even so, product items produced
under standard manufacturing conditions in accordance with their requirements for quality management
systems for medical devices (see EN ISO 13485:2016 and EN ISO 13485:2016/A11:2021) can, prior to
sterilization, have microorganisms on them, albeit in low numbers. Such product items are non-sterile. The
purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform
the non-sterile items into sterile ones.
The inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize
medical devices often approximates to an exponential relationship; inevitably this means that, regardless of
the extent of treatment applied, there is always a finite probability that a microorganism will survive. For a
given treatment, the probability of survival is determined by the number and resistance of microorganisms
and by the environment in which the organisms exist during treatment. It follows that the sterility of any one
item subjected to sterilization processing cannot be guaranteed and the sterility of the processed items has to
be defined in terms of the probability of the existence of a surviving microorganism on/in an item. The
standards for quality management systems recognize that there are processes used which cannot be fully
verified by subsequent inspection and testing of product. Sterilization is an example of such a process.
Sterilization processes are validated before use, the performance of the process monitored routinely and the
equipment maintained.
It is important to be aware that exposure to a properly validated and accurately controlled sterilization
process is not the only factor associated with the provision of assurance that the product item is sterile and, in
this respect, suitable for its intended use. Attention has also to be given to a number of factors including the
microbiological status (bioburden) of incoming raw materials and/or components, their subsequent storage
and to the control of the environment in which the product is manufactured, assembled and packaged.
1 Scope
This document specifies the requirements for a terminally sterilized medical device to be designated
‘STERILE’. Part 2 of EN 566 specifies the requirements for an aseptically processed medical device to be
designated “STERILE”.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
(ISO 13485:2016)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[Source: EN ISO 11139:2018, 3.23]
3.2
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software material,
or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human
beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment, or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy, or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
As impacted by EN ISO 13485:2016/A11:2021.
and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, but
which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions, but not in others include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[Source: EN ISO 13485:2016 , 3.11, modified — The first two list items in Note 1 to entry have been added.]
3.3
sterility
state of being free from viable micro-organisms
[Source: EN ISO 11139:2018, 3.274. Note to entry has been deleted]
3.4
sterile
free from viable micro-organisms
[Source: EN ISO 11139:2018, 3.271]
3.5
sterility assurance level
SAL
probability of a single viable microorganism occurring on an item after sterilization
Note 1 to entry: It is expressed as the negative exponent to the base 10.
[Source: EN ISO 11139:2018, 3.275]
3.6
terminally sterilized
condition of a product that has been exposed to a sterilization process in its sterilized barrier system
[Source EN ISO 11139:2018, 3.296]
4 Requirements
4.1 For a terminally sterilized medical device to be designated "STERILE", the probability of there being a
−6
viable micro-organism present on/in the device shall be equal to or less than 1×10 .
NOTE 1 Permission for acceptance of a probability greater than that specified in 4.1 may be sought through the
appropriate regulatory bodies. Such permission requires consideration of the individual situation, including
consideration of the risk management process (see, for example, EN ISO 14971) undertaken by the manufacturer of the
medical device.
NOTE 2 ISO/TS 19930 provides guidance on identifying the aspects to be considered as part of a risk-based approach
to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to
−6
withstand processing to achieve maximally a SAL of 10 .
4.2 Compliance shall be shown by the provision of documentation and records which demonstrate that the
devices have been subjected to a validated sterilization process fulfilling 4.1.
The documentation and records shall be retained as specified in EN ISO 13485:2016 , 4.2.4 and 4.2.5
...
Die Norm SIST EN 556-1:2024 behandelt die Sterilisation von Medizinprodukten und legt die Anforderungen fest, die erfüllt sein müssen, damit ein Medizinprodukt als "STERIL" bezeichnet werden kann. Der spezifische Fokus dieser Norm liegt auf terminal sterilisierten Medizinprodukten. Dies ist von enormer Bedeutung, da sie sicherstellen muss, dass die entsprechenden Produkte unter sterilen Bedingungen bereitgestellt werden, um die Sicherheit der Patienten zu gewährleisten. Ein herausragendes Merkmal dieser Norm ist ihre umfassende Struktur, die eine klare Anleitung zur Validierung des Sterilisationsprozesses bietet. In der Norm wird betont, dass die Bezeichnung "STERIL" nur dann verwendet werden darf, wenn ein validierter Sterilisationsprozess erfolgreich angewendet wurde. Dies gewährleistet, dass die verschiedenen Methoden zur Sterilisation, wie sie in den begleitenden Normen (z.B. EN ISO 11135 und EN ISO 11137) beschrieben sind, ordnungsgemäß implementiert und kontrolliert werden. Ein weiterer Stärke der SIST EN 556-1:2024 ist die Harmonisierung der Anforderungen in einem europäischen Kontext. Durch die enge Ausrichtung auf die EU-Richtlinien für Medizinprodukte wird sichergestellt, dass die Norm nicht nur den spezifischen Bedürfnissen der Produktion von Medizinprodukten gerecht wird, sondern auch die regulatorischen Anforderungen erfüllt, die in verschiedenen europäischen Ländern relevant sind. Die Relevanz dieser Norm ist ebenfalls nicht zu unterschätzen. Angesichts der globalen Bedeutung der Qualität und Sicherheit von medizinischen Geräten ist die Sicherstellung, dass Produkte als "STERIL" gekennzeichnet werden können, von zentraler Bedeutung. Die normativen Anforderungen unterstützen Hersteller dabei, Vertrauen in ihre Produkte zu schaffen und die Gesundheitsversorgung zu verbessern. Insgesamt bietet die SIST EN 556-1:2024 eine fundierte Richtlinie für Hersteller von Medizinprodukten, indem sie klare und präzise Anforderungen für die Sterilisation definiert und dadurch den Weg für sichere und zuverlässige medizinische Anwendungen ebnet.
SIST EN 556-1:2024 is a significant standard that delineates the essential requirements for medical devices to be designated as "STERILE" when terminal sterilization processes have been applied. The scope of this document is clearly defined, focusing solely on terminally sterilized medical devices, thereby ensuring that manufacturers and stakeholders within the healthcare sector have a clear guideline to follow for compliance with sterilization norms. One of the key strengths of this standard lies in its comprehensive approach to defining the criteria for a device's designation as "STERILE." By setting specific requirements, SIST EN 556-1:2024 emphasizes the necessity of employing validated sterilization processes, which bolsters patient safety and enhances the overall quality of medical devices available in the market. The standard works in conjunction with other established norms such as EN ISO 11135 and EN ISO 17665-1, among others, which focus on validation and control processes for sterilization. This interconnectedness ensures a robust framework for stakeholders involved in the sterilization of medical devices. Furthermore, the relevance of SIST EN 556-1:2024 extends beyond legal compliance; it embraces best practices that are critical in an evolving healthcare environment. With increasing scrutiny on medical device safety, adherence to this standard not only facilitates compliance with EU directives but also instills confidence among healthcare providers and patients regarding the sterility of medical devices. In summary, SIST EN 556-1:2024 plays a pivotal role in standardizing the requirements for terminally sterilized medical devices, reinforcing the importance of validated sterilization processes, and fostering a culture of safety in the medical device industry.
Le document SIST EN 556-1:2024 présente des exigences claires et rigoureuses pour la désignation de dispositifs médicaux stériles, en particulier ceux ayant subi une stérilisation terminale. Cette norme est essentielle, car elle permet de garantir seulement l'emploi de méthodes de stérilisation validées, ce qui renforce la sécurité des patients. L’une des forces majeures de cette norme réside dans son approche systématique pour définir les critères qui permettent à un dispositif médical d’être qualifié de "STÉRILE". En précisant que seule la validation d’un processus de stérilisation, conforme à des normes telles que celles énoncées dans EN ISO 11135 et EN ISO 17665-1, autorise cette désignation, la norme assure une grande rigueur dans le contrôle qualité des dispositifs médicaux. En outre, le document met en lumière l’importance des exigences de contrôle de routine pour les processus de stérilisation, garantissant ainsi que chaque produit répond aux standards de sécurité requis. Cela est particulièrement pertinent dans le contexte actuel où la sécurité des dispositifs médicaux est une préoccupation majeure pour les fabricants et les organismes de réglementation. La clarté et la précision de SIST EN 556-1:2024 en font un cadre précieux pour les fabricants de dispositifs médicaux, leur permettant de naviguer dans le processus complexe de validations et d’assurer la conformité à la législation. Par ailleurs, la distinction apportée entre les processus de stérilisation terminale et ceux de traitement aseptique, comme indiqué dans la partie 2 de cette norme européenne, souligne la pertinence de cette norme dans un cadre sanitaire où la stérilité est cruciale. En résumé, la norme SIST EN 556-1:2024 constitue un document incontournable pour le secteur des dispositifs médicaux, garantissant que les produits désignés comme "STÉRILE" satisfont à des exigences élevées en matière de sécurité et de qualité, tout en restant en conformité avec les directives de l'UE relatives aux dispositifs médicaux.
SIST EN 556-1:2024は、医療機器の滅菌に関する標準であり、その範囲は「STERILE」と指定されるための要件を定めています。この文書は、最終滅菌された医療機器に関する要件を明確にするものであり、医療機器の安全性と信頼性を確保する上で重要な役割を果たしています。 この標準の強みは、その具体的な要件が医療機器の滅菌プロセスに対して厳格であり、EUの医療機器指令に従ったものである点です。「STERILE」と指定されるためには、検証された滅菌プロセスが適用される必要があり、その文書によって求められるさまざまな基準は、滅菌工程の妥当性を保証するための信頼性を提供します。さらに、EN ISO 11135、EN ISO 11137などの関連する標準が引用されており、滅菌プロセスの検証とルーチン管理が確実に行われていることをサポートしています。 この標準は、医療機器の生産者だけでなく、使用者にとっても重要です。標準化された要件により、医療機器の安全性が確保され、感染症のリスクが低減されるため、患者の健康を守るためにも不可欠です。また、医療機器業界全体の品質向上に寄与するため、業界全体の信頼性を高める役割も果たします。 SIST EN 556-1:2024は、今後の医療機器開発においても基礎となる文書であり、持続的な品質管理と安全性の向上に資することが期待されます。医療機器の設計と製造における滅菌の重要性を再認識させる本標準は、業界の進展においても relevance を持ち続けるでしょう。
SIST EN 556-1:2024는 의료 기기를 'STERILE'로 지정하기 위한 포괄적인 요구 사항을 정립하는 중요한 표준입니다. 이 문서는 품목의 특성과 관련된 명확한 가이드라인을 제공하며, 최종적으로 멸균된 의료 기기를 어떻게 안전하게 취급하고 사용해야 하는지를 명시합니다. 이 표준의 범위는 특정한 멸균 프로세스가 적용된 의료 기기를 'STERILE'로 지정할 수 있는 조건을 자세히 설명하고 있습니다. EU 의료 기기 지침에 따르면, 의료 기기를 'STERILE'로 지정하는 데는 유효한 멸균 프로세스가 필수적이라는 점도 명확히 하고 있습니다. 이러한 점은 의료 기기의 안전성과 효율성을 보장하는 데 큰 기여를 합니다. SIST EN 556-1:2024의 강점은 다양한 멸균 방법에 대한 요구 사항이 다른 관련 표준(EN ISO 11135, EN ISO 11137, EN ISO 14160 등)과 잘 연계되어 있다는 것입니다. 이로 인해 제조업체 및 관련 의료 기기 관계자들이 멸균 과정의 검증 및 일상적 관리를 보다 일관되게 수행할 수 있습니다. 이러한 통합적 접근은 의료 기기의 품질을 향상시키고, 환자의 안전을 최우선으로 하는 데 도움이 됩니다. 또한, 이 표준은 미래의 의료 기기 개발 및 승인 절차에 따른 명확한 기준을 제공함으로써, 업계에 실질적이고도 지속 가능한 변화를 가져오는 중요한 역할을 합니다. 특히, 'STERILE' 지정 기준에 대한 명확한 해석은 규제 준수의 용이성을 높여주며, 다양한 제조 환경에서의 유연성을 발휘할 수 있게 합니다. 결론적으로, SIST EN 556-1:2024는 의료 기기의 멸균과 관련하여 권위 있는 지침을 제공하며, 혁신적이고 안전한 의료 기기 개발을 위한 필수적인 표준으로 자리매김하고 있습니다.
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