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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