ISO 19011:2011
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Guidelines for auditing management systems
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ISO 14644-6:2007
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Cleanrooms and associated controlled environments Part 6: Vocabulary
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ISO 14644-8:2013
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Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
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ISO 14160:2011
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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
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ISO/TR 10017:2003
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Guidance on statistical techniques for ISO 9001:2000
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ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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ISO 14644-2:2015
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Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
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ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 14644-5:2004
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Cleanrooms and associated controlled environments — Part 5: Operations
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ISO 14937:2009
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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
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EN 724 : 1994
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GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
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ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements
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ISO 10005:2005
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Quality management systems Guidelines for quality plans
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ISO/TR 16142:2006
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Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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ISO/TS 13409:2002
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Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
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ISO 14644-3:2005
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Cleanrooms and associated controlled environments Part 3: Test methods
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ISO 9004:2009
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Managing for the sustained success of an organization A quality management approach
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ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements
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ISO/TR 10013:2001
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Guidelines for quality management system documentation
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ISO 14644-7:2004
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Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
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EN 50103 : 1995
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GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
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ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment
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ISO 14644-1:2015
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Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
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ISO 9001:2015
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Quality management systems — Requirements
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EN 928 : 1995
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IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
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ISO 11607:2003
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Packaging for terminally sterilized medical devices
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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary
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ISO 14644-4:2001
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Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
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ISO 11134:1994
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Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 11137:1995
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Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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ISO 10007:2017
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Quality management — Guidelines for configuration management
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EN 980:2008
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Symbols for use in the labelling of medical devices
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ISO 13683:1997
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Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
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ISO 12891-1:2015
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Retrieval and analysis of surgical implants Part 1: Retrieval and handling
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ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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