Projects

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

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

60.60   Standard published

Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

60.60   Standard published

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

90.92   Standard to be revised

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

60.60   Standard published

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

90.93   Standard confirmed

Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

60.60   Standard published