Implantable medical device cleaning validation

[ifserav]

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

 

[Ronen E]

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.

 

[Ajit Basrur]

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

 

[pkost]

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-market/european-standards/harmonised-standards/medical-devices_en