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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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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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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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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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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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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 |