Clause 7.5.2 of ISO 13485:2016

[bimeri]

Is wiping considered cleaning the product?

We are producing an electronic mechanic prosthesis. During the manufacturing, there are two steps which I am not sure whether they should be considered under clause 7.5.2(e) of ISO 13485

1. The ballscrew is wiped, to avoid grease coming from the supplier. However, there is no acceptance limit for the grease. We are just wiping generally.
2. During the strain gauge installation, we apply a neutralizer and use a cotton stick to wipe it.

Should I draft a procedure for the cleanliness of the product?

 

[yodon]

Would the presence of grease or whatever you're wiping down after strain gauge installation impact safety or efficacy? Would presence make use more difficult?

 

[DanMann]

I'd cover in your risk management for production something along the lines of "What if all the grease gets wiped off" and "What if the grease isn't sufficiently wiped" and determine what risk controls you need to put in place for this. I think this would likely fall under that clause in the view of most auditors.