T/CIET 1638-2025 Active Group standards

T/CIET 1638-2025 Guidelines for assessing the performance and safety of disposable bioreactors used in biopharmaceutical production

Publish Date: 2025-08-18 Implement Date: 2025-08-18 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: T/CIET 1638-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Other chemical equipment

Publish Date: 2025-08-18

Implement Date: 2025-08-18

Scope

This document specifies the basic requirements, models, performance requirements, safety requirements, and verification and evaluation methods for single-use bioreactors used in biopharmaceuticals. This document is applicable to single-use bioreactors used in biopharmaceuticals. This document specifies the basic requirements, models, performance requirements, safety requirements, and verification and evaluation methods for single-use bioreactors used in biopharmaceuticals. This document is applicable to single-use bioreactors used in biopharmaceuticals.