GB/T 19973.1-2015 Replaced National standards

GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products

Publish Date: 2015-12-10 Implement Date: 2016-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 19973.1-2015

Standard Type: National standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2015-12-10

Implement Date: 2016-09-01

Pages: 36 pages

Scope

This part of GB/T 19973 specifies the requirements for counting and identifying the total number of viable microorganisms on (or in) medical devices, components, raw materials, and packaging, and provides guidance on the subject.

Development Information

Word Count: 58 Thousand words Pages: 36 pages

Replace the following standards

GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products

Superseded by the following standards

GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products

Referenced Standards

GB/T 27025-2008 General requirements for the competence of testing and calibration laboratories YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes ISO 10012

Adopt standards

ISO 11737-1:2006

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