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

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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

Pages: 56 pages

Scope

This document specifies the procedures and test methods for testing the cleaning effect of reusable medical devices cleaned with washer-disinfectors and their accessories.
This document is applicable to the cleaning effect test of washer-disinfectors.
This document is not applicable to the production activities of manufacturers of reusable medical devices.

Development Information

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