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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
|
|
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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EN 550 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
|
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ISO 14160:2011
|
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
|
Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
|
|
ISO 13488:1996
|
Quality systems — Medical devices — Particular requirements for the application of ISO 9002
|
|
ISO 10555-2:1996
|
Sterile, single-use intravascular catheters Part 2: Angiographic catheters
|
|
ISO 7198:2016
|
Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
|
|
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes
|
|
EN 868-1 : 1997
|
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
|
|
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
|
|
ISO 14630:2012
|
Non-active surgical implants General requirements
|
|
ISO/TS 15539:2000
|
Cardiovascular implants Endovascular prostheses
|
|
EN 552:1994/A2:2000
|
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
|
|
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
|
|
ISO 11607:2003
|
Packaging for terminally sterilized medical devices
|
|
ISO 14971-1:1998
|
Medical devices Risk management Part 1: Application of risk analysis
|
|
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
|
|
ISO 11137:1995
|
Sterilization of health care products Requirements for validation and routine control Radiation sterilization
|
|
EN 554 : 1994
|
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
|
|
ISO 10555-4:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
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