Any standards for fabrics & materials in medical devices

Le Chiffre

Quite Involved in Discussions
#1
Anyone know of any 60601 or similar standard that applies to shoulder straps, clips and bag materials that would help with safety issues as well as bio-compatibility and ease of cleaning/disinfecting. This is not a sterile medical device but is reusable, think of a camera bag for medical electronics.
Thanks.
 
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J

Jimmy the Brit

#3
Anyone know of any 60601 or similar standard that applies to shoulder straps, clips and bag materials that would help with safety issues as well as bio-compatibility and ease of cleaning/disinfecting. This is not a sterile medical device but is reusable, think of a camera bag for medical electronics.
Hi Le Chiffre,

I think everyone is scared of replying because of what your namesake did to James Bond in Casino Royale! :ko:

I have done a little digging and think that there are a couple of standards/guidance docs that might apply to your situation:

ANSI/AAMI ST35 (2003) Safe handling and biological decontamination of reuseable medical devices in health care facilities and non-clinical settings

AAMI TIR12 (2004) Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

AAMI TIR30 (2003) A compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices (This one has the test soils section for validating the cleaning process)

ANSI/AAMI ST65 (2000) Processing of reusable surgical textlies for use in health care facilities (this one is very tailored to drapes and bed-linen, but may have something you can use)

ANSI/AAMI ST58 (2005) Chemical sterilization and high-level disinfection in health care facilities

This is an interesting area to investigate - technically the bag is not a medical device, but if there is potential for biological cross contamination through its routine use there could be a tacit requirement for ensuring that you at least provide guidelines for cleaning and disinfection. Who knows there could be a source of competitive advantage in supplying sterilizable bags and straps with your products, especially in these increasing litigious times.

I hope this helps, if nothing else these documents will ensure you will be able to sleep at night; thrilling they are not!! :lol:

Enjoy,

Jim
 

Le Chiffre

Quite Involved in Discussions
#4
Thanks Jimmy, those are exactly what I was looking for :D

Funnily enough I picked my username before the Bond film came out, and I hadn't read the book either... honest!
 
J

Jimmy the Brit

#5
Thanks Jimmy, those are exactly what I was looking for :D

Funnily enough I picked my username before the Bond film came out, and I hadn't read the book either... honest!
I believe you, just keep away from those cane bottomed chairs!
 
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