EN 556-1:2001

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

• Status: Published
• Publication Date: 02-Oct-2001
• Withdrawal Date: 29-Apr-2002
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 6 - Microbiological quality of processed medical devices
• Current Stage: 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
• Completion Date: 05-Jun-2022
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 556-1:2002 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Relations

• Replaces: EN 556:1994 + A1:1998 - Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"
• Effective Date: 22-Dec-2008
• Corrected By: EN 556-1:2001/AC:2006 - Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
• Effective Date: 22-Dec-2008
• Revised: FprEN 556-1 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 556-1:2002
01-maj-2002
1DGRPHãþD
SIST EN 556:2000
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY±=DKWHYH]DPHGLFLQVNHSULSRPRþNHNL
PRUDMRELWLR]QDþHQLV67(5,/12±GHO=DKWHYH]DNRQþQRVWHULOL]LUDQH
PHGLFLQVNHSULSRPRþNH
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
SIST EN 556-1:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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.

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EN 556-1:2001 (E)
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
2

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EN 556-1:2001 (E)
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
...