Projects

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

60.60   Standard published

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

60.60   Standard published

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

90.92   Standard to be revised

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

90.60   Close of review

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

60.60   Standard published

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

90.92   Standard to be revised

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

90.92   Standard to be revised

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

90.60   Close of review

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

90.92   Standard to be revised

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

60.60   Standard published

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

60.60   Standard published

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

90.93   Standard confirmed

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor

60.60   Standard published

Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

90.20   Standard under periodical review

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

90.92   Standard to be revised

Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

90.60   Close of review

Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

60.60   Standard published

Biological evaluation of medical devices — Part 23: Tests for irritation

90.93   Standard confirmed