BS ISO 19227:2018

This standard BS ISO 19227:2018 Implants for surgery. Cleanliness of orthopedic implants. General requirements is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document 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.

This document does not specify requirements for packaging or sterilization which are covered by other International Standards.

This document applies to in-process cleaning and final cleaning.

This document does not apply to liquid or gaseous implants.

This document does not apply to cleaning processes performed by the user or under the responsibility of the user.