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DIN EN 556-2:2015-11
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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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DIN EN ISO 20857:2013-08
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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) |
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DIN EN 556-1:2002-03
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES |
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DIN EN ISO 25424:2011-09
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STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
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DIN EN ISO 17664:2016-06 (Draft)
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PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
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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 11137-3:2015-08 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
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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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DIN ISO/TS 17665-2:2009-07
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STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
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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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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 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) |
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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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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 |