IEC 18562-1 report

[AnnaSokolowska]

Dear All,

we're manufacturers of mesh and compressor nebulizers and preparing for re-certification on MDR.
Our devices need to confirm with ISO 18562 standards.
We are wondering if we could prepare a report for IEC 18562-1 by ourselves, without laboratory services and how to do it. The other parts of the standards will be evaluated by labs.
Have you got any advice, what such a report should contain and how to prepare it? Are there any templates?

Thank you in advance!

 

[planB]

Yes, principally you could prepare a such a report on your own and only outsource the bare testing to qualified laboratories. Just be beware that ISO 18562-1 requires competence and experience per section 4.1:

The biocompatibility evaluation shall be planned, carried out and documented by knowledgeable and experienced professionals.

and per section 4.6:

All tests shall be conducted according to recognized current/valid best laboratory/quality practices and the data shall be evaluated by competent, informed professionals.

HTH,

 

[Billy Milly]

In general, when testing against a certain standard is done, testing lab should be accredited. If there is no accreditation, also testing procedures are scrutinized (validation, training...). It can be done but the NB review time can extend significantly due to additional reviews.

 

[AnnaSokolowska]

Thank you!
Do you, or anyone here, know if there are any templates or guidance on how to prepare such a report on ISO 18562-1? What is mandatory information to be included?

 

[Billy Milly]

I am not familiar with this specific standard. You should start by obtaining and reading it, requirements are in there.

 

[planB]

[...] any templates or guidance on how to prepare such a report on ISO 18562-1? [...]

You may want to have a look into ISO 18562-1, section 4.5, Biocompatibility evaluation plan, and this thread; the related FDA guidance on biocompatibility evaluations also contains guidance on Attachment E: Contents of a Test Report and Attachment F: Component and Device Documentation Examples.

I definitely do not want to curb your enthusiasm, but without previous exposure to biocompatibility evaluations, I would strongly recommend to seek professional support.