YY/T 1733-2020 Active Industry standards-Medicine

YY/T 1733-2020 Radiation sterilization of medical devices—Guide for dose mapping in irradiation processing facilities

Publish Date: 2020-09-27 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1733-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2020-09-27

Implement Date: 2022-06-01

Pages: 20 pages

Scope

This standard specifies the requirements for dose distribution testing of radiation sterilization agents for medical devices and the methods for analyzing the test data.
This standard applies to dose distribution testing of gamma irradiation devices, electron beam irradiation devices, and X-ray (bremsstrahlung) irradiation devices.
This standard does not apply to dose distribution testing of unpackaged fluid products.

Development Information

Word Count: 32 Thousand words Pages: 20 pages

Referenced Standards

GB/T 16509-1996 Standard guide for estimating uncertainties in dosimetry for radiation processing GB/T 16509-2008 Standard guide for estimating uncertainties in dosimetry for radiation processing GB/T 16640-1996 Standard guide for selection and calibration of dosimetry systems for radiation processing GB/T 16640-2008 Standard guide for selection and calibration of dosimetry systems for radiation processing 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 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices

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