YY/T 1613-2018 Active Industry standards-Medicine

YY/T 1613-2018 Requirements for process characterization and control in radiation sterilization of medical devices

Publish Date: 2018-09-29 Implement Date: 2019-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1613-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2018-09-29

Implement Date: 2019-10-01

Pages: 42 pages

Scope

This standard specifies the characteristics and control requirements of the irradiation sterilization process for medical devices, and sets forth specific requirements for establishing and meeting the installation, operation, performance, and routine control of γ, electron beam, and X-ray irradiation devices as stipulated in GB 18280.1—2015.
This standard applies to the irradiation sterilization process of medical device products.

Development Information

Word Count: 79 Thousand words Pages: 42 pages

Referenced Standards

GB/T 16841-2008 Guide for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV 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 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects ISO/ASTM 51608 ISO/ASTM 51702

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