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Implantable medical device cleaning validation
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Implantable medical device cleaning validation
Implantable medical device cleaning validation
Implantable medical device cleaning validation
Implantable medical device cleaning validation
Implantable medical device cleaning validation
Implantable medical device cleaning validation
Implantable medical device cleaning validation
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Some Related Topic Tags
cleaning validation, implantable medical devices (imd), medical devices
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  Post Number #1  
Old 14th November 2017, 06:59 PM
ifserav

 
 
Total Posts: 61
Please Help! Implantable medical device cleaning validation

Dear all

We are going to produce a implantable medical device, i want to know if there are any regulation for medical device, i have been reviewing ISO 15883 Part 1, 2 , but i want to know if there are more regulations, or test to satisfy in our process.


Thanks in advance

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  Post Number #2  
Old 14th November 2017, 10:04 PM
Ronen E

 
 
Total Posts: 3,736
Re: Implantable medical device cleaning validation

Start here: Mexico Medical Device Regulations

(I have no affiliation with Emergo)

If you plan to export, the applicable (foreign) regulations depend on your planned destinations.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #3  
Old 14th November 2017, 10:55 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,173
Re: Implantable medical device cleaning validation

Quote:
In Reply to Parent Post by ifserav View Post

Dear all

We are going to produce a implantable medical device, i want to know if there are any regulation for medical device, i have been reviewing ISO 15883 Part 1, 2 , but i want to know if there are more regulations, or test to satisfy in our process.

Thanks in advance
ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and not implantables.

As a start, you can refer to the below threads:

Cleaning of Orthopaedic Implants before Sterilization

Cleaning standards for Medical Devices - Implants - Cleaning Validation
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #4  
Old 15th November 2017, 09:41 AM
pkost

 
 
Total Posts: 809
Re: Implantable medical device cleaning validation

are you providing the device in a sterile state? the sterilisation standards rely on adequate cleaning and therefore will detail requirements in them

you can take a look at the EU harmonised list as a starter for 10: https://ec.europa.eu/growth/single-m...cal-devices_en
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