YY/T 0698.1-2011 Active
YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods
Abstract
This part of YY/T 0698 specifies the requirements and test methods for co-extruded plastic films (hereinafter referred to as "blister films") used for packaging medical devices for final sterilization. This standard applies to co-extruded plastic films used for blister packaging of medical devices in medical device factories.
This part does not add any requirements to the general requirements of ISO 11607-1, so the specific requirements in clauses 4.2 to 4.5 can be used to demonstrate compliance with one or more requirements of ISO 11607-1, but not all of its requirements.
The sterile barrier system of medical devices composed of blister films and other packaging materials enables users to see the contents before opening the packaging, thus facilitating sterile operations.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0698.1-2011 |
| CCS | Generally, it refers to microsurgical instruments |
| ICS | Disinfection and sterilization |
| Implement Date | 2013-06-01 |