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ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
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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 |
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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 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 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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ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
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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 |
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ISO 20857:2010
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Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
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ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
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ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
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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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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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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/TS 11135-2:2008
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Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
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ISO/IEC 90003:2014
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Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
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ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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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 |