Standards search

Use the form below to find particular standards or projects. Enter your criteria for searching (single or in combination) in the fields below and press the button “Search”. You can also search using the Advance Search facility.

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

60.60 Standard published

CEN/TC 206

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 (ISO 10993-18:2020/Amd 1:2022)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

60.60 Standard published

CEN/TC 206