NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 10993-6 [available pre-publication] references following documents:

Document number Edition Title
ISO 10993-12 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials More 
ISO 10993-1 2025-11 Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process More 
ISO 10993-16 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More 
ISO 10993-2 2022-11 Biological evaluation of medical devices - Part 2: Animal welfare requirements More 
ISO 10993-4 2017-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More 
ISO 10993-9 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More 
ASTM F 1635 2024 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants More 
ASTM F 1983 2023 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications More 
ASTM F 3268 2026 Standard Guide for in vitro Degradation Testing of Absorbable Metals More 
ASTM F 748 2025 Standard Practice for Selecting Biological Test Methods for Materials and Devices More