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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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DIN EN ISO 10993-2:2006-10
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Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006) |
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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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ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements |
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ISO 5840-1:2015
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Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
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ISO 25539-1:2017
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Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
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IEC 62366:2007+AMD1:2014 CSV
|
Medical devices - Application of usability engineering to medical devices |
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ISO 14630:2012
|
Non-active surgical implants General requirements |
|
DIN EN ISO 5840-1:2015-12
|
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
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ASTM F 2052 : 2015 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
|
ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants General requirements |
|
DIN EN ISO 16061:2015-09
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
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ISO 8601:2004
|
Data elements and interchange formats Information interchange Representation of dates and times |
|
DIN EN ISO 14630:2013-03
|
Non-active surgical implants - General requirements (ISO 14630:2012) |
|
ISO 532:1975
|
Acoustics Method for calculating loudness level |
|
ISO/TS 11139:2006
|
Sterilization of health care products Vocabulary |
|
ASTM F 2213 : 2017 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
|
ISO/TS 12417:2011
|
Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
|
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
|
DIN EN ISO 14155:2012-01
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
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ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
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IEC 60651:1979+AMD1:1993+AMD2:2000 CSV
|
Sound level meters |
|
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |