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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
|
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
|
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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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
|
IEC/ISO 31010:2009
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Risk management - Risk assessment techniques |
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ISO 31000:2009
|
Risk management Principles and guidelines |
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ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
|
ISO 14644-5:2004
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Cleanrooms and associated controlled environments — Part 5: Operations |
|
ISO 14937:2009
|
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/IEC Guide 99:2007
|
International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
|
ISO 14698-1:2003
|
Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
|
ASTM E 2500 : 2013 : REDLINE
|
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
|
ISO 14644-3:2005
|
Cleanrooms and associated controlled environments Part 3: Test methods |
|
ISO 9004:2009
|
Managing for the sustained success of an organization A quality management approach |
|
ISO/TS 11139:2006
|
Sterilization of health care products Vocabulary |
|
ISO 11137-2:2013
|
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
|
ISO 14001:2015
|
Environmental management systems — Requirements with guidance for use |
|
ISO 14644-7:2004
|
Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
|
ISO 10012:2003
|
Measurement management systems — Requirements for measurement processes and measuring equipment |
|
ISO 14644-1:2015
|
Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
|
ISO 9001:2015
|
Quality management systems — Requirements |
|
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
|
ISO 14644-4:2001
|
Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
|
ISO/IEC Guide 2:2004
|
Standardization and related activities General vocabulary |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO/IEC 90003:2014
|
Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
|
ISO 10007:2017
|
Quality management — Guidelines for configuration management |
|
ISO Guide 73:2009
|
Risk management — Vocabulary |