BS PD ISO/TR 14969:2004

Cross References: ISO 9000:2000*ISO 13485:2003*ISO 9001:2000 *ISO 9004:2000*ISO 10005:1995*ISO 10007:2003 *ISO 10012:2003*ISO/TR 10013:2001*ISO/TR 10017:2003*ISO 11134:1994*ISO 11135:1994*ISO 11137:1995*ISO 11607:2003*ISO 11737-1:1995*ISO 12891-1:1998*ISO 13408-1:1998*ISO/TS 13409:2002*ISO 13683:1997*ISO 14155-1:2003*ISO 14160:1998*ISO 14644-1:1999*ISO 14644-2:2000*ISO 14644-3*ISO 14644-4:2001*ISO 14644-5:2004*ISO 14644-6*ISO 14644-7:2004*ISO 14644-8*ISO 14937:2000*ISO 14971:2000*ISO 15223:2000*ISO/TR 16142:1999 *ISO 19011:2002*EN 724:1994*EN 928:1995*EN 980:2003*EN 50103:1995*ISO 11607:2001*

Also available as part of KIT 160.



Keywords: Medical equipment; Medical instruments; Medical technology; Quality assurance systems; Quality assurance; Quality management; Quality; Design ; Installation; Maintenance; Production management ; Acceptance (approval)

Product Code(s): 30112807,30112807

This product references:BS EN 980:2003 - Graphical symbols for use in the labelling of medical devices
ISO 14644-3:2005 - Cleanrooms and associated controlled environments - Part 3: Test methods
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14160:1998 - Sterilization of single-use medical devices incorporating materials of animal origin -- Validation and routine control of sterilization by liquid chemical sterilants
ISO 11607:2003 - Packaging for terminally sterilized medical devices
ISO 9004:2000 - Quality management systems -- Guidelines for performance improvements
ISO 19011:2002 - Guidelines for quality and/or environmental management systems auditing
ISO 11137:1995 - Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization
ISO 14971:2000 - Medical devices -- Application of risk management to medical devices
ISO 14644-4:2001 - Cleanrooms and associated controlled environments -- Part 4: Design, construction and start-up
ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 11737-1:1995 - Sterilization of medical devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products
ISO 11135:1994 - Medical devices -- Validation and routine control of ethylene oxide sterilization
ISO 15223:2000 - Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
ISO 14937:2000 - 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 14644-7:2004 - Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14644-5:2004 - Cleanrooms and associated controlled environments - Part 5: Operations
ISO 14644-2:2000 - Cleanrooms and associated controlled environments -- Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO 14644-1:1999 - Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness
ISO 13683:1997 - Sterilization of health care products -- Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 10012:2003 - Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 11134:1994 - Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization
ISO 12891-1:1998 - Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling
ISO 13408-1:1998 - Aseptic processing of health care products -- Part 1: General requirements