Grouping Products and Testing Sterile and Biocompatibility - Validating Products


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Dear Everyone..

i have another problem concerning about the validation on our product. Grouping products and testing-sterile and biocompatibility)

1) if i have a product that have the same intended used but have different raw material. can it be registered under one cert or need to separate it? (Sputum Cup- 2 type of raw material)

2) we have product that different intended used but but have same component in the product. (EXAMPLE-PROCEDURE SET)

anyone can elaborate to me pls..


Ronen E

Problem Solver
Re: Grouping products and testing sterile and biocompatibility - Validating Product


You are actually asking 3 separate questions:

1. Can 2 different devices be certified under the same certification
2. Do these devices need separate biocompatibility evaluations
3. Do these devices need separate sterility testing (I assume you mean sterilization validation)

WRT case A - sputum cups made of different materials (I assume all the rest is identical): Probably they can be certified together. Separate biocompatibility evaluation (not necessarily testing) will be required. Separate sterilization validation most likely won't be required unless the nature of the materials is such that necessitates a different sterilization method (e.g. one is Gamma compatible but the other isn't).

WRT case B - procedure sets that are identical content-wise but with different intended use: Separate certifications will be required. Separate biocompatibility evaluation will be required only if the duration of contact and/or type of tissue being contacted are different for the different intended uses. A single sterilization validation could be used for both.



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thank you for your explanation. :agree:

but im still Confucius. :confused::confused:

let me give another example that :bonk: me
(procedure set) blood giving set and basic dressing set have same content (dressing forceps, cotton ball and gauze swabs)

did we need to do a separate Biocompatibility - Validating Products.

can anyone elobrate to me more on this validation kind.. and the law of it in simple way to understand..


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One more thing..

Please clarify Biocompatibility evaluation component other than testing..

I need a further understanding on this part..

Another question for which I need your assistance.

Where to get GMDN code...

for gamma sterile
we buy dose mapping on A product.
can we used this dose mapping on B products that about +- 10% of weight and same material used and same packaging..
can we used dose mapping on Product A on the Product B??
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