ISO 13408-4:2005
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Aseptic processing of health care products — Part 4: Clean-in-place technologies |
ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
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 |
ISO 14698-2:2003
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Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
IEC 60812:2006
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Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
EN 556-2:2015
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Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
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 |
ISO 13408-2:2003
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Aseptic processing of health care products Part 2: Filtration |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 14644-5:2004
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Cleanrooms and associated controlled environments — Part 5: Operations |
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 |
ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 13408-3:2006
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Aseptic processing of health care products Part 3: Lyophilization |
ISO 14698-1:2003
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Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
ISO 14644-3:2005
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Cleanrooms and associated controlled environments Part 3: Test methods |
ISO 9004:2009
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Managing for the sustained success of an organization A quality management approach |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
ISO 11137-3:2017
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Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
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) |
ISO 14644-1:2015
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Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 14644-4:2001
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Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
EN 1822-1:2009
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High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 13408-6:2005
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Aseptic processing of health care products Part 6: Isolator systems |
ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 13408-5:2006
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Aseptic processing of health care products Part 5: Sterilization in place |
ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |