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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ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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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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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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ASTM F 2503 : 2013 : REDLINE
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Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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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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DIN EN ISO 5840-2:2016-05
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Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
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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 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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IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices
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ISO 14630:2012
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Non-active surgical implants — General requirements
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ASTM F 2052 : 2015 : REDLINE
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Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
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ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements
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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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ISO 532:1975
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Acoustics Method for calculating loudness level
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ISO/TS 11139:2006
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Sterilization of health care products Vocabulary
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ISO 5840-3:2013
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Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
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ASTM F 2213 : 2017 : REDLINE
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Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
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ISO/TS 12417:2011
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Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
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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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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 5840-3:2013-06
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Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
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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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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 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 5840-2:2015
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Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
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IEC 60651:1979+AMD1:1993+AMD2:2000 CSV
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Sound level meters
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