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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Pages:
Publication date: 2012-07-01
Clinical investigation of medical devices - Corrigendum 1
Publication date: 2011-07-15
Clinical investigation of medical devices for human subjects - Good clinical practice
Pages: 66
Publication date: 2011-02-01
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Pages: 74
Publication date: 2010-08-01
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Publication date: 2010-06-15
Biological evaluation of medical devices - Part 1: Guidance on selection of tests - Corrigendum
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Publication date: 2010-02-15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Publication date: 2009-12-15
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Corrigendum 1
Publication date: 2009-11-15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Pages: 28
Publication date: 2009-10-15