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) |
ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
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 |
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 |
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 |
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 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
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) |
ISO 25539-1:2017
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Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices |
ISO 14630:2012
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Non-active surgical implants General requirements |
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 |
ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements |
DIN EN ISO 14630:2013-03
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Non-active surgical implants - General requirements (ISO 14630:2012) |
ISO 532:1975
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Acoustics Method for calculating loudness level |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
ISO 5840-3:2013
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Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
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 |
ISO/TS 12417:2011
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Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
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) |
ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
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) |
ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
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 |
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) |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 5840-2:2015
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Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV
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Sound level meters |