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ISO 11070:2014
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Sterile single-use intravascular introducers, dilators and guidewires |
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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 25539-2:2012
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Cardiovascular implants Endovascular devices Part 2: Vascular stents |
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CFR 21(PTS200-299) : 0
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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
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EN 556-1:2001/AC:2006
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES |
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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 16054:2000
|
Implants for surgery Minimum data sets for surgical implants |
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ISO 13960:2010
|
Cardiovascular implants and extracorporeal systems Plasmafilters |
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ISO 5840:2005
|
Cardiovascular implants Cardiac valve prostheses |
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EN 556-2:2015
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Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
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ISO 10555-2:1996
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Sterile, single-use intravascular catheters Part 2: Angiographic catheters |
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ISO 7198:2016
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Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
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ASTM F 2503 : 2013 : REDLINE
|
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
|
ISO 17475:2005
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Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements |
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ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
|
ISO 14937:2009
|
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 |
|
CFR 21(PTS800-1299) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
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ISO 10993-2:2006
|
Biological evaluation of medical devices — Part 2: Animal welfare requirements |
|
ISO 25539-1:2017
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Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
|
ISO 14630:2012
|
Non-active surgical implants General requirements |
|
ISO 5841-2:2014
|
Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads |
|
ISO/TR 14283:2004
|
Implants for surgery Fundamental principles |
|
ISO/TS 17137:2014
|
Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
|
ASTM F 2052 : 2015 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
|
ISO/TS 15539:2000
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Cardiovascular implants Endovascular prostheses |
|
ISO 13781:2017
|
Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
|
ISO 7199:2016
|
Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators) |
|
ASTM F 2213 : 2017 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
|
ISO 10993-7:2008
|
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
|
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
|
ISO 10555-3:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
|
CFR 21(PTS1-99) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
|
ISO 10555-1:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
|
ISO 15814:1999
|
Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing |
|
ISO 25539-3:2011
|
Cardiovascular implants Endovascular devices Part 3: Vena cava filters |
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
|
ISO 16428:2005
|
Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
ISO 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
|
ASTM D 638 : 2014 : REDLINE
|
Standard Test Method for Tensile Properties of Plastics |
|
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 |
|
ISO 10555-4:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
|
ISO 16429:2004
|
Implants for surgery Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods |