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GB/T 19633.2-2015 Active
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
Abstract
This part of GB/T 19633 specifies the requirements for the development and validation of the packaging process for terminally sterilized medical devices. These processes include the pre-formed sterile barrier systems, the formation, sealing, and assembly of sterile barrier systems and packaging systems.
This part is applicable to the packaging and sterilization of medical devices in industries and medical institutions.
This part does not include the packaging requirements for sterile manufacturing of medical devices. For combinations of drugs and devices, there may be other requirements as well.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 19633.2-2015 |
| CCS | Public medical equipment |
| ICS | Disinfection and packaging |
| Implement Date | 2016-09-01 |
Price
$ 47
Subtotal
$ 47
Tax
$ 0.00
Order Total (incl. tax)
$ 47