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GB/T 42186-2022: Operational specification for cold chain logistics of medical laboratory biological samples
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 42186-2022 | English | 199 |
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Operational specification for cold chain logistics of medical laboratory biological samples
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GB/T 42186-2022
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Basic data | Standard ID | GB/T 42186-2022 (GB/T42186-2022) | | Description (Translated English) | Operational specification for cold chain logistics of medical laboratory biological samples | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A20 | | Classification of International Standard | 03.080.01 | | Word Count Estimation | 10,127 | | Date of Issue | 2022-12-30 | | Date of Implementation | 2022-12-30 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42186-2022: Operational specification for cold chain logistics of medical laboratory biological samples
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 03.080.01
CCSA20
National Standards of People's Republic of China
Operational Specifications for Cold Chain Logistics of Biological Samples for Medical Testing
Posted on 2022-12-30
2022-12-30 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Organizational Requirements 1
5 Personnel and training 2
6 Device Management 2
7 Logistics Operation 2
8 Risk Control 4
9 Review and Improvement 4
Reference 5
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.
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed and managed by the National Logistics Standardization Technical Committee (SAC/TC269).
This document was drafted by. China Federation of Logistics and Purchasing, Guangzhou KingMed Medical Laboratory Group Co., Ltd., Beijing Traditional Chinese Medicine Joint Enterprise
Industry Management Co., Ltd., West China Hospital of Sichuan University, Zhongshan Hospital Affiliated to Fudan University, Peking University First Hospital, Peking University People's Hospital,
China Hematopoietic Stem Cell Donor Database Management Center, Jiangsu Provincial Center for Disease Control and Prevention, Shenzhen Huada Medical Laboratory, Dean Clinic
Break Technology Group Co., Ltd., Hangzhou Aidikang Medical Testing Center Co., Ltd., Guangzhou Da'an Clinical Testing Center Co., Ltd., Wuhan
Kangshengda Medical Laboratory Co., Ltd., Changzhou Sinopharm Medical Laboratory Co., Ltd., Shanghai Lanwei Medical Laboratory Co., Ltd.,
Shanghai Qianmai Medical Investment Management Co., Ltd., Beijing Boao Medical Laboratory Co., Ltd., Guangzhou Kaipu Medical Laboratory Development Co., Ltd., Guangzhou
Oumengweiyi Medical Testing Laboratory Co., Ltd., Shenzhen Ping An Good Medicine Medical Testing Laboratory, Tianjin Nuohe Medical Testing Institute Co., Ltd.,
Hangzhou Tongchuang Medical Testing Laboratory Co., Ltd., Guangzhou Huayinkang Medical Group Co., Ltd., Jinan Xingqi Medical Testing Co., Ltd.,
Guangzhou Jinyuda Logistics Co., Ltd., Hangzhou Yunhu Cold Chain Logistics Co., Ltd., Guoke Hengtai (Beijing) Medical Technology Co., Ltd., Beijing
Humanwell Medical Devices Co., Ltd., Shanghai Daochang Medical Technology Co., Ltd., SF Pharmaceutical Supply Chain Co., Ltd., Beijing Shengshihuaren Supply Co., Ltd.
Should Chain Management Co., Ltd., CIMC Lengyun (Beijing) Supply Chain Management Co., Ltd., Shanghai Shengsheng Logistics Co., Ltd., Beijing Yingji Logistics Co., Ltd.
Company, Guangzhou Yilu Logistics Co., Ltd., Shanghai Tengyi Boshi International Freight Forwarding Co., Ltd., Shanghai Datian Logistics Co., Ltd., Zhongjian
Yunkang (Guangzhou) Logistics Supply Chain Co., Ltd., Guizhou Zhier Medical Cold Chain Logistics Co., Ltd., Beijing Youcold Cold Chain Technology Co., Ltd., Jiangsu
Provincial Jingchuang Electric Co., Ltd., Qingdao Haier Biomedical Co., Ltd., Zhenjiang Kangfei Automobile Manufacturing Co., Ltd., Emerson
Environmental Optimization Technology (Suzhou) Co., Ltd.
The main drafters of this document. Qin Yuming, Chen Bingyi, Jia Guibin, Liu Weimin, Wang Xiaoxiao, Su Jun, Pan Baishen, Feng Zhenru, Wang Hui, Gao Dongying,
Xie Jingxin, Li Wenyu, Ding Liping, Wang Zengqiang, Zhang Zhaobao, Yu Zhihan, Chen Jing, Liu Bin, Li Zhiqiang, Gao Ping, Yang Luozhang, Ding Yingjian, Ji Yingchun,
Li Renyi, Xu Wei, Lai Bo, Cheng Shiliang, Zhou Jie, Li Yuqing, Zhong Liang, Zeng Wei, Hou Jia, Yang Zhijie, Qin Jinna, Liu Juan, Liu Chaojun, Wang Zhiyuan,
Yu Songhai, Wu Yu, Yang Yanjun, Xu Yun, Li Huiqun, Li Chaofei, Liu Zhanjie, Jia Chunwu, Wang Xinnan, Lin Bihui, Xiao Yinni, Li Yangyang, Liu Yang.
Operational Specifications for Cold Chain Logistics of Biological Samples for Medical Testing
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.
3.1
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
The physical flow process that keeps biological samples for medical testing in the required temperature environment.
3.3
An incubator for shipping biological samples for medical testing.
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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