GB/T 44353.2-2024 Active National standards

GB/T 44353.2-2024 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling

Publish Date: 2024-08-23 Implement Date: 2025-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 44353.2-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2024-08-23

Implement Date: 2025-09-01

Pages: 16 pages

Scope

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.