GB/T 35267.5-2025 Pending National standards

GB/T 35267.5-2025 Washer-disinfectors—Part 5:Performance requirements and test method criteria for demonstrating cleaning efficacy

Publish Date: 2025-12-31 Implement Date: 2027-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 35267.5-2025

Standard Type: National standards

Standard Status: Pending

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2025-12-31

Implement Date: 2027-07-01

Publisher: 国家市场监督管理总局、国家标准化管理委员会

Technical Committee: 全国消毒技术与设备标准化技术委员会(SAC/TC 200)

Pages: 56 pages

Scope

本文件规定了对使用清洗消毒器及其附件清洁可重复使用医疗器械的清洁效果进行测试的程序和试验方法。
本文件适用于清洗消毒器的清洁效果测试。
本文件不适用于可重复使用医疗器械制造商的生产活动。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、山东新华莎罗雅生物技术有限公司、山东新华医疗器械股份有限公司、中国医学科学院北京协和医院、中关村国际医药检验认证科技有限公司、迈柯唯(上海)医疗设备有限公司、广州吉好医疗科技有限公司、北京白象新技术有限公司、新乡市华西卫材有限公司

Drafting Persons:

刘国光、勾长磊、罗庆祥、袁秦、田勇、巩报贤、张青、苏裕心、张洁、汤晓炜、李亚东、崔文波、陈淑贞、冯芷媚、杨文润、刘明明、史庆伦

Word Count: 92 Thousand words Pages: 56 pages

Same series standard

GB/T 35267.4-2025 Washer-disinfectors—Part 4:Endoscope washer-disinfectors

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 ISO 15883(所有部分) ISO 15883-1:2024

Adopt standards

ISO 15883-5:2021

Related Standards

GB 18278-2000 Replaced

GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization

Publish Date: 2000-12-13

GB 18281.1-2000 Replaced

GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General

Publish Date: 2000-12-13

GB 18281.2-2000 Replaced

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Publish Date: 2000-12-13

GB 18281.3-2000 Replaced

GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization

Publish Date: 2000-12-13

GB 18282.1-2000 Replaced

GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Publish Date: 2000-12-13

YY/T 0567.2-2005 Replaced

YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration

Publish Date: 2005-04-05