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DS/EN ISO 10993-1:2009

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 0.00
Legislation:

DS/EN ISO 10993-1/AC:2010

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


Status:
Current
Type:
Correction sheet
Language:
English
Subject:
Under revision:
Price from:
€ 0.00
Legislation:

DS/EN ISO 10993-2:2006

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 60.97

DS/EN ISO 10993-3:2014

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.55
Legislation:

DS/EN ISO 10993-4:2017

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.74
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/EN ISO 10993-5:2009

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.55
Legislation:

DS/EN ISO 10993-6:2016

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 85.95
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 123.55
Legislation:

DS/EN ISO 10993-7/AC:2009

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals


Status:
Current
Type:
Correction sheet
Language:
English
Subject:
Price from:
€ 0.00
Legislation:

DS/EN ISO 10993-9:2010

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 60.97
Legislation:

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