YY/T 1268-2015: Product adoption and process equivalence for ethylene oxide sterilization

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY/T 1268-2015 (Self-service in 1-minute)
Newer / historical versions: YY/T 1268-2015

Preview True-PDF

Scope

This standard specifies the equivalence of the sterilization process when using
new equipment in the process of adopting new product or changed product into
the originally validated ethylene oxide sterilization process.
This standard applies to medical devices that have been treated by ethylene
oxide (EO) sterilization and that use conventional release or parametric release.
The ethylene oxide sterilization conditions applicable to this standard include.
a) Adding new products to the already validated ethylene oxide sterilization
process;
b) Evaluating the changes to validated products;
c) Transferring the validated process to a different site or equipment;
d) Evaluating the equivalence of the sterilization process.
Although this standard is intended for use in medical devices, its content also
applies to other related products or materials.

Basic Data

Standard ID	YY/T 1268-2015 (YY/T1268-2015)
Description (Translated English)	Product adoption and process equivalence for ethylene oxide sterilization
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	14,118
Date of Issue	2015-03-02
Date of Implementation	2016-01-01
Quoted Standard	GB/T 16886.7; ISO 11135-1-2007
Regulation (derived from)	The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard provides additional new products or product changes in existing ethylene oxide sterilization process identified using different equipment equivalence sterilization process. This Standard applies to ethylene oxide (EO) sterilization process, the traditional release or parametric release of medical devices. This Standard applies to ethylene oxide sterilization conditions include; a) the addition of new products in the ethylene oxide sterilization process has been confirmed; b) change the assessment has confirmed that the product; c) process confirmed the transfer to a different premises or equipment; equivalence d) assessment of the sterilization process. Although this standard applies to the top of the medical device, but it also applies to other products or materials.