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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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 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly 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 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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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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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 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements
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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 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 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 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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ISO 14001:2015
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Environmental management systems — Requirements with guidance for use
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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 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment
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ISO 9001:2015
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Quality management systems — Requirements
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ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary
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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 22442-3:2007
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Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
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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 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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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 14040:2006
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Environmental management Life cycle assessment Principles and framework
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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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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
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