Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

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

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

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

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity

Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

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

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

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

Biological evaluation of medical devices — Part 18: Chemical characterization of materials

Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans

Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1

Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices

Biological evaluation of medical devices — Guidance on a risk-management process

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling