ISO/AWI 19227
Implants for surgery — Cleanliness of orthopedic implants — General requirements
Reference number
ISO/AWI 19227
Edition 2
Working draft
ISO/AWI 19227
89264
A working group has prepared a draft.
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

  •  : Under development
    : New project registered in TC/SC work programme [20.00]
  •  : 2
  • ISO/TC 150
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Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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