Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2006

Publisher

British Standards Institution

This European Standard specifies the requirements for a terminally-sterilized medical device to be designated \'STERILE\'. Part2 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 EN550 , EN552 , EN554 , EN ISO14160 and EN ISO14937.

Committee	CH/198
DevelopmentNote	Supersedes 99/565209 DC and BS EN 556 (12/2001)
DocumentType	Standard
Pages	12
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN 556:1995 99/565209 DC : OCT 99

Standards	Relationship
NBN EN 556-1 : 2001 COR 2006	Identical
SN EN 556-1 : 2001 CORR 2006	Identical
NF EN 556-1 : 2002	Identical
NEN EN 556-1 : 2001 C1 2006	Identical
DIN EN 556-1:2002-03	Identical
NS EN 556-1 : 2002 AC 2006	Identical
UNE-EN 556-1:2002	Identical
I.S. EN 556-1:2002	Identical
UNI EN 556-1 : 2002	Identical
EN 556-1:2001	Identical
EN 556-1:2001/AC:2006	Identical

EN 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN ISO 14937:2009	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 14937:2009)
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 13488:1996	Quality systems — Medical devices — Particular requirements for the application of ISO 9002
EN ISO 13488 : 2000	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009	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
EN ISO 9002:1994/AC:1997	QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
ISO 9002:1994	Quality systems — Model for quality assurance in production, installation and servicing
EN 552:1994/A2:2000	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
EN ISO 9001:2015	Quality management systems - Requirements (ISO 9001:2015)
ISO 9001:2015	Quality management systems — Requirements
EN ISO 14971:2012	Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN 980:2008	Symbols for use in the labelling of medical devices
EN ISO 14160:2011	Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
EN 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT