We have a "Contract Sterilizer" to gamma irradiate our medical devices. When I asked him for his ISO 13485 certificate, I saw that their BSI certificate mentions the scope to comply per EN ISO 11137-1:2006.
The EN ISO 11137-1 is just one of the 3 parts of the EN ISO 11137 standard and has 3 parts -
Part 1 - Requirements for development, validation and routine control of a sterilization process for medical devices
Part 2 - Establishing the sterilization dose
Part 3 - Guidance on dosimetric aspects
So if the ISO 13485 certificate has the scope of just ISO 11137-1, would that be construed that Parts 2 and 3 are also covered ?
Or would the scope should have been just EN ISO 11137 and not mention the Parts ?
Thank you !
The EN ISO 11137-1 is just one of the 3 parts of the EN ISO 11137 standard and has 3 parts -
Part 1 - Requirements for development, validation and routine control of a sterilization process for medical devices
Part 2 - Establishing the sterilization dose
Part 3 - Guidance on dosimetric aspects
So if the ISO 13485 certificate has the scope of just ISO 11137-1, would that be construed that Parts 2 and 3 are also covered ?
Or would the scope should have been just EN ISO 11137 and not mention the Parts ?
Thank you !