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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) |
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DIN EN ISO 11607-1:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
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ISO 25539-2:2012
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Cardiovascular implants Endovascular devices Part 2: Vascular stents |
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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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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 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 |
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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 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
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ISO 25539-1:2017
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Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
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ISO 14630:2012
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Non-active surgical implants General requirements |
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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 EN ISO 25539-2:2013-05
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Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
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ISO 12417-1:2015
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Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
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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 14630:2013-03
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Non-active surgical implants - General requirements (ISO 14630:2012) |
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DIN EN ISO 14155:2012-01
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
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DIN EN ISO 25539-1:2015-07 (Draft)
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CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
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ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
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DIN EN ISO 12417-1:2016-02
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
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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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ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |