ISO/TC194WG3報告書
WG3主査
黒澤努
Document: ISO/TC 194

N 840

Date: 2014-04-26 ISO/TC

Animal protection

194/WG 3

aspects

The meeting was attended by 11 delegates from 4 countries.
The meeting was chaired by Dr. Tsutomu Miki Kurosawa.
WG3 for the ISO 10993-2 Biological evaluation of medical devices – Part 2: Animalwelfare requirements, discussed about following subjects.
1) Revision of Bibliography of ISO 10993-2 Animal Welfare Requirement
2) Roadmap for future revision of ISO 10993-2
3) Expansion of WG3 activities and ISO 10993-2 to other WGs4) Expansion of TC 194/WG3 activities and ISO 10993-2 to other ISOs
In resolution, minor revision should be needed after consideration of following issues.
1) Addition of “Note” in Scope for minor revision
For expansion of ISO 10993-2 activities to other ISOs, description for application of thispart of ISO should be included in Scope. Draft description of “Note” is that “Standards
developed by ISO/TC194 are intended to be applied to medical devices. Users of thispart of ISO 10993 will need to consider whether this part of ISO 10993 can be used inother application area.”
2) Review and update of bibliography for minor revision
New 4 references should be considered to be added to Bibliography, and 3 references
shall be updated.
3) Addition of ISO 10993-2 in Normative Reference of other parts of ISO 10993
It is necessary that ISO 10993-2 shall be included in Normative References of various
parts of ISO 10993 documents using animal models to recognize importance of animalwelfare.
E-group meeting among experts will be held for this WG3 through official ISO
procedures to discuss about minor revision of ISO 10993-2.
Respectfully submitted,

Dr. Tsutomu Kurosawa
Convener ISO/TC 194/WG 3

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