Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)
Quality system requirements for the production, installation and servicing of medical devices.
This International Standard specifies, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.
This International Standard, in conjunction with ISO 9002, is applicable when there is a need to assess a medical device supplier's quality system.
This standard embraces all the principles of good manufacturing practice (GMP) widely used in the manufacture of medical devices. It can only be used in combination with ISO 9002 and is not an independent standard.
History and related standards
This International Standard supersedes BS EN 46002:1997 which is withdrawn.
This Standard includes the following cross references:
ISO 8402:1994, ISO 9002:1994, ISO 11137:1995.