Standard for protective equipment
I try to download the standard for "Personal Protective Equipment" and Medical Device. I am not sure I found what standard the manufacturer might to comply with.
If we are wholesale and distributor, I also need to know how kind of certificate we have to request from our suppliers.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
It depends, first of all, what protective equipment manufacture produce, because on that list are standards for both masks, gloves and protective cloths. Therefore, the manufacturer must declare on its Declaration of Conformity the standards by which his products are made.
If you are distributor and wholesale, your suppliers are responsible for placing medical devices on the market. Your suppliers must provide you CE certificate of the medical device and optionaly ISO 13485 certificate.
Which standards are now free to donwload, please see the following link: EU standards for protective equipment – available now for free https://advisera.com/13485academy/blog/2020/04/14/free-access-to-iso-13485/
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Apr 05, 2020