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ISO 11070:2014
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Sterile single-use intravascular introducers, dilators and guidewires |
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DIN EN ISO 11607-1:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.: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 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
|
ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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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 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
|
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 |
|
DIN EN ISO 11137-1:2015-11
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
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ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
|
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
|
ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
|
ISO 14630:2012
|
Non-active surgical implants General requirements |
|
DIN EN ISO 14155-1:2009-11
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
|
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
|
Cardiovascular implants Endovascular prostheses |
|
DIN EN ISO 14630:2013-03
|
Non-active surgical implants - General requirements (ISO 14630:2012) |
|
DIN EN ISO 11607-2:2014-11
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
|
DIN EN ISO 11135-1:2007-08
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
|
ASTM F 2213 : 2017 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
|
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
|
EN 12006-3:1998+A1:2009
|
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
|
ISO 10555-3:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
|
ISO 10555-1:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
|
EN 14299 : 2004
|
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
|
ISO 11134:1994
|
Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
|
DIN EN ISO 14160:2011-10
|
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/TS 11135-2:2008
|
Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
|
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 |
|
DIN EN ISO 14155-2:2009-11
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
|
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 |