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GB/T 16886.7-2015 Active
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
Abstract
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).
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 16886.7-2015 |
| CCS | Medical devices |
| ICS | Laboratory medicine |
| Implement Date | 2017-01-01 |
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