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FprEN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: requirements for aseptically processed medical devices
ISO 10993-4 DAM 1
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1
ISO 10993-12 DAM 1
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1
ISO 10993-17 DAM 1
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1
ISO 10993-23 DAM 1
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models
ISO/AWI 10993-2
Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO/AWI 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO/AWI TS 17664-3
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 3: Guidance on the designation of a reusable medical device to a cleaning classification.
ISO/CD 10993-3
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO/CD 10993-11
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity