Biocompatibility Test of Blue Gown vs Blue Drape

[regfocus]

Question:

We have blue Surgical Drapes (EO sterilized) and blue Surgical Gowns (EO sterilized) with the same material, color and manufacturing process (everything is same, the only difference is just one is drape and another is gown).

If blue surgical gown (EO sterilized) has been tested for biocompatibility and complies with ISO 10993 standards, can we claim the blue surgical drapes (EO sterilized) complies with biocompatibility based on biocompatibility tests of blue surgical gown (EO sterilized)?

 

[MIREGMGR]

Probably. It'll depend on exactly how the lab report was written. If the material is described sufficiently well (i.e. non generically), the examiner might accept it.

Note however that PB70 also is relevant, and different test methods apply to gowns.