NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 25539-2 [CURRENT] references following documents:

Document number Edition Title
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 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ASME V&V 40 2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices More 
ASTM F 2079 2009 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents More 
ASTM F 2081 2006 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents More 
ASTM F 2182 2019 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging More 
ASTM F 2394 2007 Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System More 
ASTM F 2743 2011 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems More 
ASTM F 2914 2012 Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices More 
ASTM F 3067 2014 Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents More