T/SDCA 007-2021 Active Group standards

T/SDCA 007-2021 The Tai Shan quality pre-filled syringe assembly

Publish Date: 2021-11-01 Implement Date: 2021-12-01 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: T/SDCA 007-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 2021-11-01

Implement Date: 2021-12-01

Scope

Main technical content: The pre-filled syringe is a disposable, sealed container packaging system used for packaging and storing injectable drugs and directly used for injection. It simultaneously has the functions of storing drugs and ordinary injection, and belongs to high-risk packaging containers. This standard aims to regulate its naming and classification, production and manufacturing processes, production environment, packaging and storage, quality control, and other life cycle elements, becoming a common technical requirement that all parties involved in production and use must abide by, ensuring that the production of pre-filled syringes is standardized, the quality is controllable, and the existing risks are reduced.