The challenge to global acceptance of Part 3 of ISO 10993.
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.
Carraway
J
J
NAMSA, Northwood, Ohio 43619, USA. jcarraway@namsa.com
Ghosh
C
C
D004864:Equipment and Supplies / Q000009:adverse effects* / Q000592:standards; D005062:European Union; D017408:Guidelines as Topic; D007564:Japan; D009152:Mutagenicity Tests / Q000379:methods* / Q000592:standards; D009154:Mutation; D014481:United States; D014486:United States Food and Drug Administration