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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DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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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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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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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)
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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
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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 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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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)
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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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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
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ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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DIN EN ISO 11737-2:2010-04
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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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DIN EN ISO 22442-2:2016-05
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
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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 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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DIN EN ISO 11138-1:2015-10 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
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DIN EN ISO 22442-3:2008-03
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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
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ISO 11138-1:2017
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Sterilization of health care products — Biological indicators — Part 1: General requirements
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ISO 22442-3:2007
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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
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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
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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 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
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DIN EN ISO 10993-17:2009-08
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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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
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DIN EN ISO 22442-1:2016-05
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
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