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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 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)
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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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EN 556:1994 + A1:1998
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
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DIN EN ISO 17475:2008-07
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CORROSION OF METALS AND ALLOYS - ELECTROCHEMICAL TEST METHODS - GUIDELINES FOR CONDUCTING POTENTIOSTATIC AND POTENTIODYNAMIC POLARIZATION MEASUREMENTS
|
|
DIN EN ISO 15223-1:2015-08 (Draft)
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MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
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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
|
|
DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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|
ISO 11135:2014
|
Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
|
|
DIN EN ISO 7198:2017-07
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Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
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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
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|
ISO/TR 37137:2014
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Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
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|
DIN EN ISO 10555-4:2013-11
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Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
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|
ISO 17475:2005
|
Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements
|
|
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 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
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|
ASTM F 3044 : 2014
|
Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
|
|
ISO 5840-1:2015
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Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
|
|
ASTM F 3067 : 2014
|
Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
|
|
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)
|
|
DIN EN ISO 11070:2015-03
|
STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
|
|
ISO/TS 17137:2014
|
Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
|
|
DIN EN ISO 17665-1:2006-11
|
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 17665-1:2006)
|
|
ASTM F 2052 : 2015 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
|
|
DIN EN ISO 14630:2013-03
|
Non-active surgical implants - General requirements (ISO 14630:2012)
|
|
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
|
|
DIN EN ISO 14155:2012-01
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
|
|
ISO 10555-1:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
|
|
ASTM F 2942 : 2013
|
Standard Guide for <emph type="bdit">in vitro</emph> Axial, Bending, and Torsional Durability Testing of Vascular Stents
|
|
ISO 80369-7:2016
|
Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
|
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice
|
|
ASTM F 2914 : 2012
|
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
|
|
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 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 10555-1:2013-11
|
INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013 + AMD 1:2017)
|
|
ISO 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
|
|
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
|
|
ASTM F 640 : 2012 : REDLINE
|
Standard Test Methods for Determining Radiopacity for Medical Use
|
|
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
|
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