Draft
International Standard
ISO/DIS 19227
Implants for surgery — Cleanliness of orthopedic implants — General requirements
Reference number
ISO/DIS 19227
Edition 2
© ISO 2026
Draft International Standard
Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 19227:2018

Abstract

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.

General information

  • Status
     : Under development
    Stage
    : DIS registered [40.00]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 150
    ICS :
    11.040.40 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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