NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 25539-2 [CURRENT] references following documents:
Document number | Edition | Title |
---|---|---|
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 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
ISO 14160 | 2020-09 | 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 More |
ISO 14630 | 2012-12 | Non-active surgical implants - General requirements 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 |
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 |