EN 556-2:2003

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

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), designating that a medical device is 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (in preparation).

Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als STERIL gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte Medizinprodukte

Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STERILE" - Partie 2: Exigences pour les dispositifs médicaux préparés aseptiquement

La présente Norme européenne fixe les exigences à satisfaire pour qu'un dispositif médical ayant subi une préparation aseptique puisse être étiqueté "STÉRILE".
NOTE   Dans le cadre des Directives UE concernant les dispositifs médicaux (voir Bibliographie), l'apposition d'une étiquette "STÉRILE" sur un dispositif médical n'est admise que si un procédé de stérilisation validé a été utilisé. Les exigences de validation et de contrôle de routine des traitements aseptiques sont spécifiées dans le prEN 13824 (en cours d'élaboration).

Sterilizacija medicinskih pripomočkov – Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" – 2. del: Zahteve za medicinske pripomočke, izdelane v aseptičnem okolju

General Information

• Status: Withdrawn
• Publication Date: 16-Dec-2003
• Withdrawal Date: 01-Sep-2015
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 02-Sep-2015
• 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/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to 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 556-2:2004 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

Relations

• Replaced By: EN 556-2:2015 - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
• Effective Date: 09-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2004
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY±=DKWHYH]DPHGLFLQVNHSULSRPRþNHNL
PRUDMRELWLR]QDþHQLV67(5,/12±GHO=DKWHYH]DPHGLFLQVNHSULSRPRþNH
L]GHODQHYDVHSWLþQHPRNROMX
Sterilization of medical devices - Requirements for medical devices to be designated
"STERILE" - Part 2: Requirements for aseptically processed medical devices
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als STERIL
gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte
Medizinprodukte
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en
vue d'obtenir l'étiquetage "STERILE" - Partie 2: Exigences pour les dispositifs médicaux
préparés aseptiquement
Ta slovenski standard je istoveten z: EN 556-2:2003
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 556-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2003
ICS 11.080.01
English version
Sterilization of medical devices - Requirements for medical
devices to be designated “STERILE” - Part 2: Requirements for
aseptically processed 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 2: Exigences pour les dispositifs Teil 2: Anforderungen an aseptisch hergestellte
médicaux préparés aseptiquement Medizinprodukte
This European Standard was approved by CEN on 1 October 2003.
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,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 556-2:2003 E
worldwide for CEN national Members.

Contents
page
Foreword . 3
Introduction . 4
1 Scope. 5
2 Normative references. 5
3 Terms and definitions. 5
4 Requirements . 6
Annex ZA (informative) Clauses of this European Standard addressing essential
requirements or other provisions of EU Directives. 8
Bibliography . 9
Foreword
This document (EN 556-2:2003) 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 June 2004, and conflicting national standards
shall be withdrawn at the latest by June 2004.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
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
EN 556-1 Sterilization of medical devices - Requirements for medical devices to be
designated "Sterile" - Part 1: Requirements for terminally-sterilized medical
devices
EN 1174 Sterilization of medical devices - Estimation of the population of micro-
organisms on product
EN ISO 14160 Sterilization of single uses medical devices incorporating materials of animal
origin - Validation and routine control of the 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)
prEN 13824 Sterilization of medical devices - Validation and routine control of aseptic
processes - Requirements and guidance (in preparation)
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, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Introduction
Medical devices designated 'STERILE' are prepared using appropriate and validated methods.
Whenever possible, sterile medical devices are terminally-sterilized using a properly validated
and controlled sterilization process (see EN 556-1, EN 550, EN 552, EN 554 and EN ISO 14937).
When a medical device is intended to be sterile but cannot be terminally-sterilized, aseptic
processing is the method of manufacture (see prEN 13824 and EN ISO 14160).
Aseptic processing requires that either
i) the entire product is sterilized and then introduced into a sterilized package; or,
ii) components of the product are sterilized, then further processed/assembled, and the
final product packed into a sterilized package.
Processing and packaging are carried out in a manner that minimizes the opportunity for items to
become recontaminated and in a controlled environment in which microbial and particulate levels
are maintained at or below defined limits and human intervention is minimized.
NOTE: EN 980 specifies the label applied to aseptically processed medical devices as
STERILE A.
1 Scope
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), designating that a
medical device is 'STERILE' is only permissible when a validated sterilization process has been applied.
Requirements for validation and routine control of aseptic processes are specified
...