DIN EN ISO 11135:2014-10
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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) |
DIN ISO 8601:2006-09
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DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
DIN EN ISO 15223-1:2015-08 (Draft)
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MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
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 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 14161:2010-03
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements |
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 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment |
ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
DIN EN ISO 18472:2006-10
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
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 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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 |
DIN EN ISO 11140-1:2015-03
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Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |