NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 25539-1 [CURRENT] references following documents:

Document number Edition Title
ISO 7198 2016-08 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches More 
ISO 11135 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-1 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-1 AMD 1 2013-07 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1 More 
ISO 11137-2 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More 
ISO 11137-3 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 14937 2009-10 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 More 
ASTM F 2213 2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment More 
ASTM F 2394 2007 Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System More