Approved Work Item
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 19227
Implants for surgery — Cleanliness of orthopedic implants — General requirements
Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 19227
Edition 2
Approved Work Item
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 19227
89264
A working group has prepared a draft.
Will replace Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½± 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.

Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.

Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 applies to in-process cleaning and final cleaning.

Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 does not apply to liquid or gaseous implants.

Ïã¸ÛÁùºÏ²Ê¿ª½± 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.

General information

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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