GB 18280.1-2015 Active National standards force_standard

GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

Publish Date: 2015-12-31 Implement Date: 2017-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 18280.1-2015

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2015-12-31

Implement Date: 2017-07-01

Pages: 31 pages

Development Information

Word Count: 57 Thousand words Pages: 31 pages

Same series standard

GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects

Replace the following standards

GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization

Referenced Standards

GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes ISO 10012-1 ISO 11737-1 ISO 11737-2

Adopt standards

ISO 11137-1:2006

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