EN 556-1:2001
(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 European Standard 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 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden
Diese Europäische Norm 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 in EN 550, EN 552, EN 554, EN ISO 14160 und EN ISO 14937 angegeben.
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1: Exigences relatives aux dispositifs médicaux stérilisés au stade terminal
La présente Norme européenne spécifie les exigences à satisfaire pour qu'un dispositif médical ayant subi une stérilisation terminale puisse être étiqueté « STERILE ». La partie 2 de cette norme européenne spécifie les exigences relatives aux dispositifs médicaux aseptisés en vue d'obtenir l'étiquetage « STERILE ».
NOTE Dans le cadre des directives CE concernant les dispositifs médicaux (voir Bibliographie), l'apposition d'une étiquette « STERILE » n'est admise que si un procédé de stérilisation validé a été utilisé. Les exigences de validation et de contrôle de routine des procédés de stérilisation des dispositifs médicaux sont spécifiés dans les EN 550, EN 552, EN 554, EN ISO 14160 et EN ISO 14937.
Sterilizacija medicinskih pripomočkov – Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" – 1. del: Zahteve za končno sterilizirane medicinske pripomočke
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2002
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SIST EN 556:2000
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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 STERILE - Partie 1: Exigences relatives aux dispositifs
médicaux stérilisés au stade terminal
Ta slovenski standard je istoveten z: EN 556-1:2001
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.
EUROPEAN STANDARD
EN 556-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2001
ICS 11.080.01 Supersedes EN 556:1994
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 relatives Sterilisation von Medizinprodukten - Anforderungen an
aux dispositifs médicaux en vue d'obtenir l'étiquetage Medizinprodukte, die als “STERIL” gekennzeichnet werden
STERILE - Partie 1: Exigences relatives aux dispositifs - Teil 1: Anforderungen an Medizinprodukte, die in der
médicaux stérilisés au stade terminal Endpackung sterilisiert wurden
This European Standard was approved by CEN on 18 August 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 556-1:2001 E
worldwide for CEN national Members.
Contents
Foreword.3
Introduction .4
1 Scope .4
2 Normative references.4
3 Terms and definitions .4
4 Requirements.6
Annex ZA (informative) Clauses of this European Standard addressing essential requirements
or other provisions of EU Directives.7
Bibliography .8
Foreword
This European Standard 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 April 2002, and conflicting national standards shall be withdrawn at the latest by
April 2002.
This European Standard supersedes EN 556:1994.
This European Standard has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard.
This standard has been considered by CEN/TC 204 as one of a sequence of European Standards concerned with
sterilization processes and their control. The other standards in this series are:
EN 550 Sterilization of medical devices -Validation and routine control of ethylene oxide sterilization.
EN 552 Sterilization of medical devices -Validation and routine control of sterilization by irradiation
EN 554 Sterilization of medical devices -Validation and routine control of moist heat sterilization
prEN 556-2 Sterilization of medical devices - Requirements for medical devices to be designated "Sterile" -
Part 2: Requirements for aseptically processed medical devices (in preparation)
EN 1174 Sterilization of medical devices - Estimation of the population of micro-organisms on product
EN ISO 14160 Sterilization of single-use medical devices incorporating materials of animal origin - Validation
and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)
EN ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical
devices (ISO 14937:2000)
Annexes designated ‘informative’ are given only for information. In this standard annex ZA is informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom.
Introduction
A sterile product item is one, which is free of viable micro-organisms. 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 systems for medical devices
(see EN ISO 13485:2000 or EN ISO 13488:2000) may, prior to sterilization, have micro-organisms 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 micro-organisms 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 micro-organism will survive. For a given treatment, the
probability of survival is determined by the number and resistance of micro-organisms and by the environment in
which the organisms exist during treatment. It follows that the ste
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Frequently Asked Questions
EN 556-1:2001 is a standard published by the European Committee for Standardization (CEN). 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 European Standard 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 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
This European Standard 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 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
EN 556-1:2001 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.
EN 556-1:2001 has the following relationships with other standards: It is inter standard links to EN 556:1994 + A1:1998, EN 556-1:2024, EN 556-1:2001/AC:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 556-1:2001 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/BC/CEN/89/9. 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 EN 556-1:2001 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 CEN standards.
The EN 556-1:2001 standard is a critical component in the framework of medical device sterilization, explicitly detailing the requirements for medical devices to be designated 'STERILE'. This European Standard establishes a comprehensive set of criteria that ensures terminally sterilized medical devices meet stringent safety and efficacy requirements. The scope of EN 556-1:2001 is particularly significant as it delineates the specific conditions under which devices can be labeled as 'STERILE'. By focusing on terminally sterilized medical devices, the standard reinforces the importance of validated sterilization processes, thereby enhancing patient safety and minimizing the risk of infections associated with medical device usage. This focus on terminal sterilization is crucial for ensuring that the sterility of the device is maintained throughout its lifecycle, from manufacturing through to use in clinical settings. One of the key strengths of this standard lies in its robust framework for defining what constitutes 'STERILE' status. The requirement for a validated sterilization process, as stipulated, ensures that manufacturers adhere to a high level of quality control. Furthermore, the reference to additional standards for the validation and routine control-such as EN 550, EN 552, EN 554, EN ISO 14160, and EN ISO 14937-provides a comprehensive guide for compliance and promotes consistency across the industry. The relevance of EN 556-1:2001 extends beyond compliance; it serves as a foundational element in the regulatory landscape for medical devices within the European Union. As medical technology continues to advance, this standard remains vital in guiding manufacturers in the development and implementation of effective sterilization processes. It guarantees that devices marketed as 'STERILE' not only meet the expectations of healthcare providers but also instill confidence in patients regarding their safety. Overall, EN 556-1:2001 stands out as a pivotal standard in the sterilization of medical devices. Its detailed requirements and emphasis on validated processes contribute significantly to protecting public health, maintaining industry standards, and fostering trust in medical devices designated as 'STERILE'.
La norme EN 556-1:2001 est essentielle pour la stérilisation des dispositifs médicaux, spécifiant les exigences nécessaires pour qu'un dispositif médical soit désigné comme "STERILE". Cette norme s'applique exclusivement aux dispositifs qui ont subi une stérilisation terminale, garantissant ainsi leur sécurité et leur efficacité lors de leur utilisation. Un des points forts de cette norme réside dans sa clarté sur le processus de stérilisation. En stipulant qu’un dispositif doit avoir subi un processus de stérilisation validé, elle assure un haut niveau de confiance tant pour les fabricants que pour les utilisateurs des dispositifs médicaux. De plus, la norme mentionne des références spécifiques à d'autres normes importantes, telles que EN 550 et EN ISO 14160, qui renforcent les exigences concernant la validation et le contrôle des processus de stérilisation. La pertinence de EN 556-1:2001 ne se limite pas à la conformité réglementaire, mais s'étend à l'assurance de la qualité et de la sécurité des soins de santé. En définissant précisément les conditions nécessaires à la désignation de "STERILE", la norme protège non seulement les patients mais également les professionnels de santé en réduisant les risques d'infection. Ainsi, EN 556-1:2001 est un document fondamental pour garantir que les dispositifs médicaux stériles répondent aux attentes les plus strictes en matière de sécurité et de qualité, faisant d'elle une norme incontournable dans le domaine de la stérilisation des dispositifs médicaux.
Die Norm EN 556-1:2001 legt die Anforderungen für medizinische Geräte fest, die als "STERIL" bezeichnet werden sollen, nachdem sie einem terminalen Sterilisationsprozess unterzogen wurden. Der Umfang dieser Norm ist von entscheidender Bedeutung, da sie klare und präzise Richtlinien bietet, die sicherstellen, dass nur medizinische Geräte, die diese strengen Kriterien erfüllen, als steril gekennzeichnet werden dürfen. Dies ist besonders wichtig in einem Bereich, in dem die Sicherheit der Patienten oberste Priorität hat. Eine der Stärken der Norm EN 556-1:2001 ist ihre enge Verknüpfung mit der EU-Richtlinie für Medizinprodukte, was die Einhaltung gesetzlicher Vorgaben fördert. Darüber hinaus wird durch diese Norm sichergestellt, dass der Begriff "STERILE" nur verwendet wird, wenn ein validierter Sterilisationsprozess angewendet wurde. Dadurch wird ein hohes Maß an Vertrauen in die Sicherheit und Wirksamkeit medizinischer Geräte geschaffen. Die Relevanz dieser Norm wird auch durch ihren Einfluss auf die Entwicklung und den Markt für medizinische Geräte unterstrichen. Hersteller, die sich an die Anforderungen der EN 556-1:2001 halten, sind in der Lage, die Marktfähigkeit ihrer Produkte zu erhöhen, da die Einhaltung international anerkannter Standards Vertrauen bei Gesundheitsdienstleistern und Patienten schafft. Der Document Name, SIST EN 556-1:2002, bezieht sich auf die implementierte Version der Norm, die zusätzliche Klarheit und Unterstützung für die Umsetzung der geforderten Standards bietet. Insgesamt stellt die EN 556-1:2001 eine fundamentale Norm dar, die sowohl technische Anforderungen als auch Qualitätsstandards für sterile medizinische Geräte definiert und somit einen wichtigen Beitrag zur Verbesserung der Patientensicherheit leistet.
SIST EN 556-1:2002 표준은 의료 기기 분야에서 중요한 역할을 하는 "STERILE"이라는 이름을 부여받기 위한 요구 사항을 명확히 정의하고 있습니다. 이 표준은 최종적으로 멸균된 의료 기기가 "STERILE"로 지정되기 위한 필수 요구 사항을 다루고 있으며, 의료 기기에 대한 안전성과 효과성을 보장하기 위한 기준을 제공합니다. 이 표준의 강점 중 하나는 치밀하게 정의된 멸균 프로세스 요구 사항입니다. EN 556-1:2001에 명시된 대로, "STERILE"로 지정되기 위해서는 검증된 멸균 프로세스가 적용되어야 하며, 이는 의료 기기의 신뢰성을 높이는 데 중요한 요소입니다. 또한 표준은 멸균 방법의 유효성을 보장하기 위해 EN 550, EN 552, EN 554, EN ISO 14160 및 EN ISO 14937과 같은 관련 표준과의 연계성을 강조합니다. 범위 측면에서, 이 표준은 최종적으로 멸균된 의료 기기에 대한 요구 사항만을 다루지만, EN 556 시리즈의 다른 부분들과 함께 aseptically 처리된 의료 기기에 대한 요구 사항도 다루고 있어, 종합적인 멸균 기준 체계를 제공합니다. 이는 의료 기기 제작자들에게 명확한 가이드를 제공하여 제품의 품질과 안전성을 높이는 데 기여합니다. 이러한 이유로 SIST EN 556-1:2002 표준은 의료 기기의 멸균 및 품질 관리에 있어 필수적인 문서로서 그 중요성을 잃지 않습니다. 표준의 명확한 정의와 요구 사항은 의료 기기의 사용 안전성을 증대시키며, 환자의 건강을 우선시하는 모든 분야에서 긍정적인 영향을 미칠 것입니다.
標準EN 556-1:2001は、医療機器の滅菌に関する標準の中で極めて重要な位置を占めています。この標準は、ターミナル滅菌された医療機器が「STERILE」として指定されるための要件を明確に規定しています。具体的には、ターミナル滅菌が行われた医療機器に対する要求事項が含まれており、EU指令で定められた医療機器に関する基準に準拠しています。 EN 556-1:2001の強みは、滅菌プロセスが検証された場合にのみ医療機器を「STERILE」として認めるという厳格な要件を設けている点です。この要求により、安全で効果的な医療機器の提供が確保され、医療現場での感染リスクを軽減する役割を果たしています。また、標準は、滅菌プロセスの検証と日常的な管理に関してEN 550、EN 552、EN 554、EN ISO 14160およびEN ISO 14937に準拠することを求めており、これらはプロセスの信頼性と一貫性を保証します。 この標準の関連性は、医療機器業界における規制や基準が厳格化されている現代の環境においてますます高まっており、医療機器の製造者や供給者が信頼性のある製品を提供するための基盤となります。EN 556-1:2001は、医療機器の安全性を確保し、患者の健康を守るために欠かせない文書です。
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