Projects

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CEN

Method(s) of test to evaluate mutagenicity

20.60 Close of comment period

CEN/TC 206
CEN

Method(s) of test to evaluate carcinogenicity

20.60 Close of comment period

CEN/TC 206
CEN

Biological testing of medical and dental materials and devices - Method(s) of test to evaluate systemic toxicity (ISO 10993-9)

20.60 Close of comment period

CEN/TC 206
CEN

Biological evaluation of medical devices - Methods of testing for degradation products

10.99 New project approved

CEN/TC 206
CEN

Biological evaluation of medical devices - Glutaraldehyde and formaldehyde residuals

10.99 New project approved

CEN/TC 206
CEN

Residuals of glutaraldehyde

10.99 New project approved

CEN/TC 206
CEN

Residuals of formaldehyde

10.99 New project approved

CEN/TC 206

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 irritation and skin sensitization (ISO 10993-10:2010)

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 10993-15:2000)

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: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

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

60.55 Ratification completed (DOR)

CEN/TC 206