Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 (ISO 10993-10:2002/Amd 1:2006)
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Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
