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ISO 13408-4:2005
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Aseptic processing of health care products — Part 4: Clean-in-place technologies
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EN ISO 14644-4:2001
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Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
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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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EN 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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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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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 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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EN ISO 13408-3:2011
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Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
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EN ISO 13408-4:2011
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Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
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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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EN 556-2:2015
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Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
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EN ISO 13408-5:2011
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Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
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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 13408-2:2003
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Aseptic processing of health care products Part 2: Filtration
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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
|
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/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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EN 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 (ISO 11135:2014)
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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 13408-3:2006
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Aseptic processing of health care products Part 3: Lyophilization
|
|
ISO 14698-1:2003
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Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
|
|
EN ISO 11137-2:2015
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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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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|
EN ISO 9001:2015
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Quality management systems - Requirements (ISO 9001:2015)
|
|
ISO 9004:2009
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Managing for the sustained success of an organization A quality management approach
|
|
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary
|
|
ISO 11137-3:2017
|
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
|
|
EN ISO 14698-2:2003/AC:2006
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CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
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|
EN ISO 14644-5:2004
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Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
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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 14644-1:2015
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Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
|
|
ISO 9001:2015
|
Quality management systems — Requirements
|
|
EN ISO 11137-1:2015
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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 (ISO 11137-1:2006, including Amd 1:2013)
|
|
EN ISO 14971:2012
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary
|
|
ISO 14644-4:2001
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Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
|
|
EN 1822-1:2009
|
High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
|
|
EN ISO 13408-6:2011/A1:2013
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
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|
EN 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 (ISO 17665-1:2006)
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
EN ISO 14644-2:2015
|
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
|
|
EN ISO 20857:2013
|
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
|
|
ISO 13408-6:2005
|
Aseptic processing of health care products Part 6: Isolator systems
|
|
EN ISO 14644-1:2015
|
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
|
|
EN ISO 14160:2011
|
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 (ISO 14160:2011)
|
|
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
|
|
ISO 13408-5:2006
|
Aseptic processing of health care products Part 5: Sterilization in place
|
|
EN ISO 14644-3:2005
|
CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
|
|
ISO 15223:2000
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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