ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.
ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.
ISO 19227:2018 applies to in-process cleaning and final cleaning.
ISO 19227:2018 does not apply to liquid or gaseous implants.
ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.
| Edition : | 1st |
| File Size : | 1
file
, 740 KB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 24 |
| Published : | 03/01/2018 |
| Same As : | ISO 19227:2018 |