GB 18279-2023 Pending National standards force_standard

GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices

Publish Date: 2023-09-08 Implement Date: 2026-10-01 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 18279-2023

Standard Type: National standards

Standard Status: Pending

is_force_gb: yes

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2023-09-08

Implement Date: 2026-10-01

Pages: 60 pages

Scope

This document specifies the requirements for the development, validation, and routine control of the ethylene oxide sterilization process during the manufacturing of medical device products, and is applicable to medical devices that are sterilized with ethylene oxide.

Development Information

Word Count: 116 Thousand words Pages: 60 pages

Replace the following standards

GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB/T 18279.2-2015 Sterilization of health care products—Part 2:Guidance on the application of GB 18279.1

Referenced Standards

GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1:General requirements GB 18281.2-2015 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements GB 18282.1-2015 Sterilization of health care products—Chemical indicator—Part 1:General requirements GB/T 18282.1-2025 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Adopt standards

ISO 11135:2014

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