GB/T 44353.2-2024 Active
GB/T 44353.2-2024 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling
Abstract
This document specifies the control requirements for the sourcing, collection, and disposal (including storage and transportation) of animal and tissue materials used in the manufacture of medical devices, and does not apply to in vitro diagnostic medical devices. The risk management process requirements set forth in ISO 22442-1 apply.
Note: The selection of animal sources is particularly important for TSE risk management (when using animal tissues and/or their derivatives from cattle, sheep, goats, deer, elk, minks, and cats).
This document does not apply to medical devices that use human tissues.
This document does not address the requirements for a quality management system controlling all stages of medical device production.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 44353.2-2024 |
| CCS | Medical devices |
| Implement Date | 2025-09-01 |