YY/T 0681.1-2018 Active Industry standards-Medicine

YY/T 0681.1-2018 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging

Publish Date: 2018-12-20 Implement Date: 2020-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0681.1-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Integrated disinfection and sterilization

Publish Date: 2018-12-20

Implement Date: 2020-01-01

Pages: 14 pages

Scope

This part of YY/T 0681 specifies guidelines for designing accelerated aging programs.
This part is applicable to quickly determining the impact of time on the sterile integrity of the sterile barrier system specified in GB/T 19633.1—2015 and the physical properties of its packaging material components.
Note 1: The information obtained from this part of YY/T 0681 is used to support the validity period (i.e., shelf life) of the sterile barrier system of medical devices.

Development Information

Word Count: 26 Thousand words Pages: 14 pages

Same series standard

YY/T 0681.14-2018 Test methods for sterile medical device package—Part 14:Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air

Replace the following standards

YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging

Referenced Standards

GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 4857.2-1992 Packaging—Transport packages—Temperature and humidity conditioning GB/T 4857.2-2005 Packaging—Basic tests for transport packages—Part 2:Temperature and humidity conditioning

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