ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
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 |
DIN EN ISO 14644-1:2016-06
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CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015) |
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 |
DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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 |
DIN EN ISO 11137-1:2015-11
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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) |
DIN EN ISO 14161:2010-03
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
DIN EN ISO 14644-4:2003-06
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Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001) |
DIN EN ISO 11138-2:2015-10 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
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 |
DIN EN ISO 17665-1:2006-11
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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/TS 11139:2006
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Sterilization of health care products Vocabulary |
DIN EN ISO 11135-1:2007-08
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
DIN EN ISO 9000:2015-11
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QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
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) |
ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment |
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
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Quality management systems — Requirements |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
DIN EN ISO 9001:2015-11
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QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
ISO 14644-4:2001
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Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
DIN EN ISO 14160:2011-10
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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 (ISO 14160:2011) |
DIN EN ISO 11737-1:2009-09
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STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
ISO/TS 11135-2:2008
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Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
ISO/IEC 90003:2014
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Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
DIN ISO/TS 11135-2:2010-01
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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 |