Y
ybs80
Are there any cleaning standards available for medical device, specifically implants? I need them for my company's cleaning validation.
Cleaning standards for Medical Devices - Implants - Cleaning Validation
Also refer -
AAMI TIR No. 12: 2004 - Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers.
AAMI TIR No. 30: 2003 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
Refer FDA article under Sources of Additional Information (bottom of page)
and MHRA Guidance Documents
AAMI TIR No. 12: 2004 - Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers.
AAMI TIR No. 30: 2003 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
Refer FDA article under Sources of Additional Information (bottom of page)
and MHRA Guidance Documents
Are implants reusable?
M
MIREGMGR
Are implants reusable?
At least with the FDA, that would be a challenging Pre Market Approval process, I'd think.
Plus, ummm...who in the clinical-care chain would do the implant removal and return-to-vendor once it, ummm, was no longer needed?
Are implants reusable?
My mistake Al. I only focussed on "Are there any cleaning standards available for medical device" but missed the word, "specifically implants" in the OP. :mg:
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Y
ybs80
My device is single-use.
M
MIREGMGR
As Al suggested, does EN556 answer your questions?
D
dhansbalaa
. Also residual spec details.
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