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ISO 19227:2018

Implants for surgery — Cleanliness of orthopedic implants — General requirements

Publication date:   Mar 21, 2018

General information

90.92 Standard to be revised   Mar 28, 2024

ISO

ISO/TC 150 Implants for surgery

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 19227:2018
90.92 Standard to be revised
Mar 28, 2024

REVISED BY

IN_DEVELOPMENT
ISO/AWI 19227