10993-11 vs 2006 gap analysis

[MDRexpert]

Can someone share whitepaper or gap analysis for 10993-11. Thanks!

 

[planB]

The foreword to ISO 10993-11:2017 should give you a pretty good overview:

This third edition cancels and replaces the second edition ( ISO 10993-11:2006) , which has been technically revised with the following changes:

1. reduction in group size for chronic toxicity testing in Table 1;
2. a new Annex F was added;
3. the original Annex F was moved to Annex G;
4. a new Annex H was added;
5. the Bibliography was updated.

HTH,

 

[MDRexpert]

Thank you!