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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 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 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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CSA Z314.2 : 2009
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EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS
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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 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 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/IEC Guide 99:2007
|
International vocabulary of metrology Basic and general concepts and associated terms (VIM)
|
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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/TS 11139:2006
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Sterilization of health care products Vocabulary
|
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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 14001:2015
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Environmental management systems — Requirements with guidance for use
|
|
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
|
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
|
Quality management systems — Fundamentals and vocabulary
|
|
ISO 11138-1:2017
|
Sterilization of health care products — Biological indicators — Part 1: General requirements
|
|
ISO 22442-3:2007
|
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
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
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
|
|
ISO/IEC 90003:2014
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Software engineering Guidelines for the application of ISO 9001:2008 to computer software
|
|
ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
|
|
IEC 61010-1:2010+AMD1:2016 CSV
|
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
|
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ISO 14040:2006
|
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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