GB/T 16886.7-2015 Active National standards

GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2015-12-10 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.7-2015

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2015-12-10

Implement Date: 2017-01-01

Pages: 80 pages

Scope

This part of GB/T 16886 specifies the allowable limits of residual ethylene oxide (EO) and 2-chloroethanol (ECH) on single-use medical devices sterilized by EO, the testing steps for EO and ECH, and the method for determining whether the devices can be shipped. The informative appendix also provides other background information, including guidelines and a flowchart for the application of this part.
This part does not include EO-sterilized devices that do not come into contact with patients (such as in vitro diagnostic devices).
Note: This part does not specify the limits of ethylene glycol (EG).