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WB/T 1115-2021Specification for in vitro diagnostic reagent temperature control logistics service (English PDF)

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Issued by

National Development and Reform Commission of the People's Republic of China

Level / Type

National · Recommended

Issue date

May 31, 2021

Implementation date

July 1, 2021

Scope

WB/T 1115-2021 (Specification for in vitro diagnostic reagent temperature control logistics service) is available as an English-translated PDF.

WB/T 1115-2021 — This document specifies the basic requirements, personnel and training, facilities and equipment, logistics operations, and temperature monitoring of temperature-controlled logistics services for in vitro diagnostic reagents and control, traceability and application, and emergency treatment.

This document is applicable to the temperature-controlled logistics service of in vitro diagnostic reagents in accordance with the management of medical devices.

This document does not apply to in vitro diagnostic reagent temperature control logistics service.

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Document preview — WB/T 1115-2021

National Standard of the People's Republic of China

ICS: 11.040.01
Classification: C 30

Issued by: National Development and Reform Commission of the People's Republic of China

Document data1

Document data

Chinese classification (CCS): C30.

Estimated length of the Chinese original: 7,780 words.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 5 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 34399Temperature control facilities validation for pharmaceutical products cold chain logistics — Technical specification for performance qualification

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