Harmonized Standards


EN ISO 10993-1

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

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EN ISO 10993-03

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

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EN ISO 10993-04

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

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EN ISO 10993-05

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

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EN ISO 10993-06

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

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EN ISO 10993-07

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

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EN ISO 10993-09

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

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EN ISO 10993-11

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

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EN ISO 10993-12

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

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EN ISO 10993-13

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

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