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GB/T 19633.2-2024 Active
GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
Abstract
This document specifies the development and validation requirements for the final sterilization of medical device packaging processes. These processes include the pre-molding of sterile barrier systems, the molding, sealing, and assembly of sterile barrier systems and packaging systems. This document does not apply to the packaging of sterile-manufactured medical devices. For drug-device combinations, there may be additional requirements.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 19633.2-2024 |
| CCS | Public medical equipment |
| ICS | Disinfection and packaging |
| Implement Date | 2025-12-01 |
Price
$ 75
Subtotal
$ 75
Tax
$ 0.00
Order Total (incl. tax)
$ 75