BS PD CEN ISO/TR 14969:2005

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): 30156028,30156028

This product references:ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 11134:1994 - Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization
ISO 11135:1994 - Medical devices -- Validation and routine control of ethylene oxide sterilization
ISO 10012:2003 - Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 9004:2000 - Quality management systems -- Guidelines for performance improvements
ISO 11137:1995 - Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization
ISO 13408-1:1998 - Aseptic processing of health care products -- Part 1: General requirements
ISO 14971:2000 - Medical devices -- Application of risk management to medical devices
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 14644-4:2001 - Cleanrooms and associated controlled environments -- Part 4: Design, construction and start-up
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 14160:1998 - Sterilization of single-use medical devices incorporating materials of animal origin -- Validation and routine control of sterilization by liquid chemical sterilants
ISO 13683:1997 - Sterilization of health care products -- Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 12891-1:1998 - Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling
ISO 19011:2002 - Guidelines for quality and/or environmental management systems auditing
ISO 11607:2003 - Packaging for terminally sterilized medical devices
BS EN 980:2003 - Graphical symbols for use in the labelling of medical devices
ISO 15223:2000 - Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
ISO 14644-5:2004 - Cleanrooms and associated controlled environments - Part 5: Operations
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 10007:2003 - Quality management systems - Guidelines for configuration management
ISO 9001:2000 - Quality management systems -- Requirements

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BS EN ISO 11607-1:2006- Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systemsBS EN ISO 11607-2:2006- Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processesBS EN ISO 10993-1:2009- Biological evaluation of medical devices. Evaluation and testing within a risk management processBS EN ISO 14971:2009- Medical devices. Application of risk management to medical devices