GB/T 45351-2025 Active
GB/T 45351-2025 Manufacture of cell-based medical devices—Control of microbial risks during processing
Abstract
This document specifies the minimum requirements for cell-based medical devices subject to control of microbial contamination when processed using risk-based methods, and provides guidance for them.
This document applies to both cell-based medical devices labeled as "sterile" and those without such labeling. Other cell-based medical products may refer to this document for use.
This document does not apply to:
——the procurement and transfer of cell starting materials used in the processing of cell-based medical devices,
——in vitro diagnostic reagents.
This document does not stipulate biosafety protection requirements.
This document cannot replace regulations related to the production and quality control of cell-based medical devices.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 45351-2025 |
| CCS | Public medical equipment |
| ICS | Integrated disinfection and sterilization |
| Implement Date | 2026-09-01 |