Do we need ISO 13485?
We are a manufacturer of cleaning chemicals, some of which are used in the medical industry, for cleaning medical devices, apparatus, equipment, etc.
We have always been led to believe that we needed to adhere to ISO 13485 however, upon reading the document, I am not sure that it applies to us. Can your expert provide further clarification please?
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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
According to the MDR 2017/745, Annex VIII Classification rules, Rule 16 covers the disinfectant and states the following:
All devices intended specifically to be used for disinfecting or sterilizing medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.
So, if your cleaning chemicals are used to disinfect those devices (mentioned in rule 16), they are either class IIa or class IIb. This means that you need to have certified your cleaning chemicals according to the MDR and your quality management system according to the ISO 13485:2016.
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Sep 15, 2022