GB/T 44876-2024 Active National standards

GB/T 44876-2024 Implants for surgery—Cleanliness of orthopedic implants—General requirements

GB/T 44876-2024 Implants for surgery—Cleanliness of orthopedic implants—General requirements

Publish Date: 2024-10-26 Implement Date: 2025-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 44876-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-10-26

Implement Date: 2025-11-01

Pages: 20 pages

Scope

This document, based on the risk management process, specifies the cleanliness requirements for orthopaedic implants (hereinafter referred to as implants) and the requirements for test methods used in the confirmation and control of cleaning processes.
This document does not specify requirements for packaging and sterilization, which are covered by other documents.
This document applies to process cleaning and final cleaning.
This document does not apply to liquid and gaseous implants.
This document does not apply to cleaning processes performed by or under the responsibility of users.

Development Information

Word Count: 31 Thousand words Pages: 20 pages

Referenced Standards

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products ISO 9377-2 ASTM D7066-04

Adopt standards

ISO 19227:2018

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