SIST EN 556-1:2002
(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
SIST EN 556-1:2002 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 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.
SIST EN 556-1:2002 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 556-1:2002 has the following relationships with other standards: It is inter standard links to SIST EN 556:2000, SIST EN 556-1:2002/AC:2006, SIST EN 556-1:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 556-1:2002 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 SIST EN 556-1:2002 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.
The standard SIST EN 556-1:2002 addresses the sterilization requirements for medical devices, specifically identifying the criteria necessary for a medical device to be designated as "STERILE" when terminally sterilized. The scope of this standard is crucial as it provides comprehensive guidelines that ensure safety and effectiveness in medical practice, reaffirming the necessity of applying a validated sterilization process. One of the primary strengths of SIST EN 556-1:2002 is its clear delineation of the requirements for terminally sterilized medical devices, thereby promoting consistency and safety across the medical device industry. This standard not only enhances the quality of medical devices but also helps manufacturers comply with EU directives, which is essential for legal market entry in various countries. Furthermore, the relevance of this standard extends beyond its immediate scope; it also complements other important documents related to the validation and routine control of sterilization processes, such as EN 550, EN 552, EN 554, EN ISO 14160, and EN ISO 14937. This interconnectedness ensures that stakeholders in the medical industry have access to a cohesive framework for the development, testing, and approval of sterilized medical devices. In summary, SIST EN 556-1:2002 serves as a foundational standard that underlines the importance of validated sterilization processes in the designation of medical devices as "STERILE". Its rigorous requirements not only enhance device safety but also support manufacturers in meeting regulatory expectations, making it a vital component of medical device quality assurance.
SIST EN 556-1:2002は、医療機器の滅菌に関する欧州規格であり、特に「STERILE」として指定されるための端末滅菌医療機器の要件を詳細に規定しています。この標準の範囲は、製品が「STERILE」として認識されるために必要な基準を明確にすることで、医療機器の安全性と有効性を確保することにあります。 この規格の強みは、滅菌が適切に実施された医療機器が患者に与える影響を最小限に抑えることに重点を置いている点です。具体的には、滅菌プロセスの検証及び日常的な管理に関する要件が明示されており、これにより医療機器の製造業者は、その製品が安全であることを顧客に証明するための基盤を持つことができます。また、関連する他の規格（EN 550、EN 552、EN 554、EN ISO 14160、EN ISO 14937）との整合性が取れているため、規格全体の適用性と信頼性が高まっています。 SIST EN 556-1:2002は、EU指令に準拠した医療機器の滅菌基準を確立しており、医療機器の設計、製造、管理に携わる専門家にとって極めて重要な標準です。この規格が求める滅菌プロセスの検証は、製品の市場流通を可能にし、患者の安全を守るための重要なステップとなっています。したがって、医療業界におけるこの標準の関連性は、今後ますます重要になると考えられます。
SIST EN 556-1:2002 표준은 'STERILE'로 지정된 의료 기기에 대한 요구 사항을 규정하는 중요한 문서입니다. 이 표준은 최종 멸균 절차를 통해 제작된 의료 기기가 'STERILE'로 인정받기 위해 충족해야 하는 요구 사항을 명확하게 정의하고 있습니다. 본 문서의 주요 강점은 의료 기기의 안전성과 신뢰성을 보장하기 위한 체계적인 접근 방식을 제공한다는 점입니다. 유럽 표준에 따라, 의료 기기가 'STERILE'로 지정되기 위해서는 검증된 멸균 과정이 반드시 적용되어야 하며, 이는 환자 안전을 최우선으로 생각하는 의료 기기 제조업체들에게 중요한 기준이 됩니다. 또한, SIST EN 556-1:2002 표준은 멸균 의료 기기에 대한 요구 사항 외에도 EN 550, EN 552, EN 554, EN ISO 14160, EN ISO 14937 등의 추가 규격을 참조하여 멸균 공정의 검증과 정기적 관리에 대한 요구 사항을 포함하고 있습니다. 이러한 연계로 인해 표준의 실효성이 더욱 강화되며, 의료 기기의 품질 관리와 일관성을 촉진합니다. 따라서 SIST EN 556-1:2002 표준은 의료 기기의 멸균 과정과 관련하여 필수적이고 포괄적인 지침을 제공하며, 업계의 변화와 요구에 능동적으로 대응할 수 있는 강력한 근거를 마련합니다. 이 표준은 의료 기기 제조업체들이 국제적으로 신뢰받는 제품을 생산하는 데 기여하는 필수적인 도구입니다.
Die SIST EN 556-1:2002 ist eine entscheidende europäische Norm, die die Anforderungen für medizinische Geräte festlegt, die als "STERIL" bezeichnet werden. Der Fokus dieser Norm liegt speziell auf terminal sterilisierten medizinischen Geräten. Ein wesentlicher Aspekt dieser Norm ist die klare Definition und Festlegung der Kriterien, die erfüllt werden müssen, um die Bezeichnung "STERIL" zu legitimieren. Die Stärke der SIST EN 556-1:2002 liegt in ihrer strengen Regulierung bezüglich der Validierung von Sterilisationsprozessen. Die Norm betont, dass eine medizinische Einrichtung nur dann ein Gerät als "STERIL" bezeichnen darf, wenn ein validierter Sterilisationsprozess erfolgreich angewendet wurde. Dies stellt sicher, dass die Sicherheit der Patienten jederzeit gewährleistet ist, da die Norm präzise Vorgaben zur Validierung und zur routinemäßigen Kontrolle solcher Prozesse enthält. Ein weiterer positiver Aspekt dieser Norm ist die klare Abgrenzung zu anderen Normen, die sich mit der Sterilisation und der Konformität medizinischer Produkte befassen. Die Verweise auf relevante Normen wie EN 550, EN 552, EN 554, EN ISO 14160 und EN ISO 14937 liefern zusätzliche Informationen zur Standardisierung von Sterilisationsverfahren, was ihre Relevanz für die gesamte Branche unterstreicht. Insgesamt ist die SIST EN 556-1:2002 von zentraler Bedeutung für die Gewährleistung von Standards in der Sterilisation medizinischer Geräte. Ihre strengen Anforderungen und präzisen Vorgaben tragen nicht nur zur Sicherheit im Gesundheitswesen bei, sondern fördern auch das Vertrauen der Verbraucher in die Qualität und Sicherheit von medizinischen Produkten, die als "STERIL" klassifiziert sind.
La norme SIST EN 556-1:2002 joue un rôle crucial dans l'assurance qualité des dispositifs médicaux en définissant les exigences nécessaires pour qu'un dispositif médical soit désigné comme "STERILE". Son champ d'application se concentre spécifiquement sur les dispositifs médicalement stérilisés terminalement, garantissant ainsi que les produits mis sur le marché respectent des critères de sécurité et d'efficacité rigoureux. L'un des principaux atouts de cette norme est son approche systématique de la validation des processus de stérilisation. Elle établit des conditions précises en s'appuyant sur des processus validés, ce qui assure que tout dispositif médical, une fois désigné "STERILE", a subi des contrôles rigoureux. Cela renforce la fiabilité des dispositifs aux yeux des professionnels de la santé et des patients, en minimisant le risque de contamination. De plus, la norme fait partie d'un ensemble de directives européennes sur la stérilisation, s'inscrivant dans une continuité avec le travail réalisé au sein des autres normes, telles que EN 550, EN 552, et EN ISO 14160. Cette interconnexion garantit une cohérence dans les exigences de stérilisation, favorisant ainsi une harmonisation au niveau européen. La pertinence de la norme SIST EN 556-1:2002 est donc indéniable dans le cadre des réglementations sur les dispositifs médicaux, car elle établit un cadre clair pour le design et le contrôle des produits stériles. En intégrant cette norme dans leurs pratiques, les fabricants peuvent non seulement respecter les exigences légales, mais également assurer une sécurité optimal à leurs utilisateurs.
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