YY/T 1608-2018 Active Industry standards-Medicine

YY/T 1608-2018 Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits

Publish Date: 2018-06-26 Implement Date: 2019-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1608-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2018-06-26

Implement Date: 2019-07-01

Pages: 14 pages

Scope

This standard specifies an improved method for selecting and reviewing sterilization doses in GB 18280.2-2015. This method not only ensures that the product meets the expected sterility assurance level, but also reduces the number of product units required. It also describes the sampling plan for verification dose experiments and sterilization dose reviews. This standard applies to the sampling of sterilization dose selection and review in GB 18280.2-2015 to ensure that the product meets the expected sterility assurance level.

Development Information

Word Count: 24 Thousand words Pages: 14 pages

Referenced Standards

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 GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 19973.2-2005 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the validation of a sterilization process

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