YY/T 1544-2017 Active Industry standards-Medicine

YY/T 1544-2017 Ethylene oxide sterilization safety and effectiveness basic supply requirements

Publish Date: 2017-05-02 Implement Date: 2018-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1544-2017

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2017-05-02

Implement Date: 2018-04-01

Pages: 12 pages

Scope

This standard specifies the quality management system, management responsibilities, personnel requirements, infrastructure, working environment, design of ethylene oxide sterilization systems, and environmental monitoring requirements for ethylene oxide sterilization systems.
This standard applies to ethylene oxide sterilization, providing a basic guarantee for safe and effective ethylene oxide sterilization.
This standard does not apply to regulating the performance of ethylene oxide sterilizers, their use, or the requirements of the ethylene oxide sterilization process.

Development Information

Word Count: 20 Thousand words Pages: 12 pages

Referenced Standards

GB/T 19001-2000 Quality management systems—Requirements GB/T 19001-2008 Quality management systems—Requirements GB/T 19001-2016 Quality management systems—Requirements GB 30000.3-2013 Rules for classification and labelling of chemicals—Part 3:Flammable gases GB 30000.18-2013 Rules for classification and labelling of chemicals—Part 18:Acute toxicity YY 0503-2005 Ethylene oxide sterilizer YY 0503-2016 Ethylene oxide sterilizer YY 0503-2023 Ethylene oxide sterilizer YY/T 0822-2011 Ethylene oxide liquefied gas for sterilization GB 50016-2014 Code for fire protection design of buildings GB 50058-2014 Code for design of electrical installations in explosive atmospheres GB 50116-2013 Code for design of automatic fire alarm system GB 50057-2010 Code for design protection of structures against lightning GB 50257-2014 Electrical installation engineering Explosion and fire hazardous environment electrical installation construction and acceptance specifications

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