VOTE ON COMMITTEE DRAFT

ISO/CD 10993-18.2

Biological evaluation medical devices - Part 18:

Chemical characterization of materials

We do not agree to the circulation of the draft as a DIS.

The reason for our disagreement are as follows:

1.　We consider the ultimate goal of this part should be to provide a standard procedure of chemical characterization (qualitative and quantitative) of materials for serving biological evaluation, not to provide the overall risk assessment procedure.　In other words, this part must be designed to provide sufficient CHEMICAL information of "MATERIAL CHARACTERIZATION (the first box in Annex C of ISO 10993-1)" to answer the questions given in the following procedures of Annex C of Part 1.

2.　We consider that this part must be technical as far as possible rather than conceptual.

Otherwise a requirement for preparing a new guidance document will be raised.

　
3.　We propose WG14 to reconsider an alternative framework such as the attached flow charts for example:　We provide them only for discussion in WG14, while they are so immature.

　
Yours sincerely,
　

Akitada Nakamura

NIHS/DMD