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Article

The challenge to global acceptance of Part 3 of ISO 10993.

Medical device technology - 1 Jun 2006

Carraway J, Ghosh C

Abstract excerpt

ISO 10993, Part 3: Testing for Genotoxicity, Carcinogenicity and Reproductive Effects, is not a globally recognised standard. The differences in these testing requirements in Europe, the United States and Japan are explained together with guidance on when to test and efficient strategies to adopt when marketing products in these regions.

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PMID: 16903383

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PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 5 Sept 2026. Manifest publication-graph-cohort-2026-09-05.1.

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