GB/T 42186-2022Operational specification for cold chain logistics of medical laboratory biological samples (English PDF)
医学检验生物样本冷链物流运作规范
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 30, 2022
Implementation date
December 30, 2022
Scope
GB/T 42186-2022 is the English-translated version of 医学检验生物样本冷链物流运作规范.
GB/T 42186-2022 is the Chinese operational specification for the cold chain logistics of biological samples for medical testing.
It covers the organizational requirements, personnel and training, equipment management, the logistics operation itself, risk control, and review and improvement; it defines the samples as material taken or derived from the human body for diagnosis or medical research, listing blood, tissue, secretions, cells, skin, bone marrow, muscle and hair, and it fixes the contents of the biosafety kit, from the risk disposal flow chart to disinfectant containing 75% alcohol, iodophor, swabs, bandages, gauze, tweezers, absorbent cotton and yellow waste bags.
It applies to the service and management of enterprises carrying such samples. Issued on 30 December 2022, it has applied from the same day.
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Document preview — GB/T 42186-2022
National Standard of the People's Republic of China
- ICS
- 03.080.01
- Classification
- A 20
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Organizational Requirements
- 5 Personnel and training
- 6 Device Management
- 7 Logistics Operation
- 8 Risk Control
- 9 Review and Improvement
- Reference
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting.
1 Scope
This document specifies the organizational requirements, personnel and training, equipment management, and logistics operations during the cold chain logistics operation of medical test biological samples. industry, risk control, review and improvement.
This document is applicable to the service and management of medical laboratory biological sample cold chain logistics enterprises.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 34399 Technical specifications for equipment verification performance confirmation of cold chain logistics temperature control facilities for pharmaceutical products
GB/T 37864-2019 General requirements for quality and capacity of biobanks
WB/T 1104 Functional Configuration Requirements for Refrigerated Vehicles for Road Transport of Pharmaceutical Products
3 Terms and Definitions
The following terms and definitions defined in GB/T 37864-2019 apply to this document.
3.3 An incubator for shipping biological samples for medical testing
3.1 biological sample
Biomaterials obtained or derived from the human body for medical research or diagnostic purposes.
Note: including but not limited to blood, tissue, secretions, cells, skin, bone marrow, muscle, hair, etc.
3.2 cold chain logistics
The physical flow process that keeps biological samples for medical testing in the required temperature environment.
3.4 Biosafetytoolkit
Containing composite materials required for emergency disposal in order to minimize possible harm or pollution to personnel and the environment caused by pathogenic microorganisms tool kit.
Note: The biological protection kit includes but is not limited to the following items. biological protection kit configuration table, biosafety risk disposal flow chart, disinfection items containing 75% alcohol, Disinfection items containing iodophor, cotton swabs, bandages, gauze, tweezers, absorbent cotton, yellow garbage bags, etc.
4 Organizational Requirements
4.1 It should have the qualifications of a legal person and engage in relevant activities.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 34399-2025 — Temperature control facilities validation for pharmaceutical products cold chain logistics — Technical specification for performance qualification
GB/T 37864-2019 — General requirements of quality and competence for biobank
GB/T 7251.4-2026 — Low-voltage switchgear and controlgear assemblies - Part 4: Particular requirements for assemblies for construction sites (ACS)
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