Medical device repairs (to upholstery)

James

Involved In Discussions
#1
Hi

Just wondered if anyone could point me in the direction of some relevant information or standards. I'm looking for best practices in relation to reupholstering medical devices; specifically examination couches. We have an engineering and upholstery unit capable of undertaking such work, and the recovered items are for use solely by our patients / in our institution in the UK; I'm just not sure of the precise regulatory position.

I cant seem to find any specific clinical upholstery standards by ISO / BSI etc

Thanks

James
 
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#2
Short of trawling the ISO website, I'd ask your customer what standards they would like/mandate you to adhere to - in my industry standards are customer driven so they won't purchase from you unless you meet them.
 

James

Involved In Discussions
#3
Short of trawling the ISO website, I'd ask your customer what standards they would like/mandate you to adhere to - in my industry standards are customer driven so they won't purchase from you unless you meet them.
Thanks.. The slight problem is that we are the customer! We are an NHS institution in the UK. We make stuff for patients, and I'm also thinking that we could extend our manufacturing departments remit to include basic repairs to upholstery within our Trust. We would manage this through our 13485 system, but I cant find expected standards for upholstery of plinths and couches, etc..
 

James

Involved In Discussions
#5
Was there an original specification when new?
Hi Ed - no, we dont make the plinths; we dont have product specifications just product manuals, which dont give instruction for re-upholstery.

Manufacturers aren't being very helpful in terms of what standards they would expect with re-upholstery.
 
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