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EN ISO 11737-2:2009
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Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
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IEC 61010-2-040:2015
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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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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EN 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 14937:2009)
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EN 61010-2-040:2015
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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ISO 11138-3:2017
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Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
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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 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 11737-2:2009
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Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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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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EN ISO 10993-17:2009
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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EN ISO 11138-3:2017
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Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
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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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EN ISO 11138-2:2017
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Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
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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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EN ISO 11138-1:2017
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Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
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ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 11138-1:2017
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Sterilization of health care products — Biological indicators — Part 1: General requirements
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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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EN 61010-1:2010
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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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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IEC 61010-1:2010+AMD1:2016 CSV
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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ISO/TR 7871:1997
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Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques
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ISO 10012-1:1992
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Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
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ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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EN ISO 10993-1:2009/AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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