IEC 61025:2006
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Fault tree analysis (FTA)
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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 19011:2011
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Guidelines for auditing management systems
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ISO 14644-8:2013
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Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
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ISO 14698-2:2003
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Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
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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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IEC 60812:2006
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Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
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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
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ISO 31000:2009
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Risk management Principles and guidelines
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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 14644-5:2004
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Cleanrooms and associated controlled environments — Part 5: Operations
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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 14698-1:2003
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Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
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ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards
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ASTM E 2500 : 2013 : REDLINE
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Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
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ISO 14644-3:2005
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Cleanrooms and associated controlled environments Part 3: Test methods
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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/TS 11139:2006
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Sterilization of health care products Vocabulary
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ISO 14001:2015
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Environmental management systems — Requirements with guidance for use
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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/IEC Guide 2:2004
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Standardization and related activities General vocabulary
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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/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 10007:2017
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Quality management — Guidelines for configuration management
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IEC 60601-1-4:1996+AMD1:1999 CSV
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Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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ISO/IEC Guide 98-3:2008
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Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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