Multi-part Document
BS EN ISO 10993 - Biological evaluation of medical devices
https://doi.org/10.3403/BSENISO10993
This is a multi-part document divided into the following parts:
- Part 1 Biological evaluation of medical devices. Evaluation and testing
- Part 2 Biological evaluation of medical devices. Animal welfare requirements
- Part 3 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
- Part 4 Biological evaluation of medical devices. Selection of tests for interactions with blood
- Part 5 Biological evaluation of medical devices. Tests for in vitro cytotoxicity
- Part 6 Biological evaluation of medical devices. Tests for local effects after implantation
- Part 7 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
- Part 8 Biological evaluation of medical devices. Selection and qualification of reference materials for biological tests
- Part 9 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
- Part 10 Biological evaluation of medical devices. Tests for irritation and sensitization
- Part 11 Biological evaluation of medical devices. Tests for systemic toxicity
- Part 12 Biological evaluation of medical devices. Sample preparation and reference materials
- Part 13 Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices
- Part 14 Biological evaluation of medical devices. Identification and quantification of degradation products from ceramics
- Part 15 Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys
- Part 16 Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables
- Part 17 Biological evaluation of medical devices. Establishment of allowable limits for leachable substances
- Part 18 Biological evaluation of medical devices. Chemical characterization of materials
- Part 23 Biological evaluation of medical devices. Tests for irritation