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Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: requirements for aseptically processed medical devices

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1

Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models

Biological evaluation of medical devices - Part 2: Animal welfare requirements

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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.

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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