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SN/T 4738-2016 English PDF

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SN/T 4738-2016: General procedure and requirements of quality assessment on the diagnostic kits used in entry-exit animal quarantine
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Basic data

Standard ID SN/T 4738-2016 (SN/T4738-2016)
Description (Translated English) General procedure and requirements of quality assessment on the diagnostic kits used in entry-exit animal quarantine
Sector / Industry Commodity Inspection Standard (Recommended)
Classification of Chinese Standard B41
Word Count Estimation 6,667
Date of Issue 2016-12-12
Date of Implementation 2017-07-01
Regulation (derived from) State-Quality-Inspection-Accredidation (2016) No.590
Issuing agency(ies) General Administration of Customs

SN/T 4738-2016: General procedure and requirements of quality assessment on the diagnostic kits used in entry-exit animal quarantine


---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.
(General procedures and requirements for quality assessment of animal and poultry quarantine kits) People's Republic of China Entry-Exit Inspection and Quarantine Industry Standard Quality of entry and exit animal quarantine kit General procedures and requirements for evaluation work Released on December 12,.2016 2017-07-01 implementation People's Republic The General Administration of Quality Supervision, Inspection and Quarantine issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Certification and Accreditation Administration. This standard was drafted. China Academy of Inspection and Quarantine, Beijing Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, the Chinese people Heguo Shenzhen Entry-Exit Inspection and Quarantine Bureau, Shanghai Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China. The main drafters of this standard. Wang Qin, Lin Xiangmei, Liu Jian, Ma Guiping, Qin Zhifeng, Li Jian, Wu Shaoqiang, Li Xiaolin, Liu Xiaofei, Qiu Songyu, Feng Chunyan, Mei Lin, Liu Dandan. Quality of entry and exit animal quarantine kit General procedures and requirements for evaluation work

1 Scope

This standard specifies the objects, principles and procedures for the quality evaluation of entry and exit animal quarantine kits. This standard is applicable to the quality evaluation of the animal quarantine kit for inbound and outbound.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. SN/T 2435-2010 Quality Assessment Procedure for Entry-Exit Animal Quarantine Diagnostic Kit

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Quality assessment of entry and exit animal quarantine reagents qualityassessmentondiagnostickitsusedinentry-exitanimal Quarantine Applicability and stability evaluation of commercial kits for quarantine of inbound and outbound animals.

4 Evaluation object

The subject of quality assessment of inbound and outbound animal quarantine reagents is the kit used in the quarantine of inbound and outbound animals, including approval Animal quarantine kits for sale and use in China also include kits with special requirements in animal quarantine work.

5 Evaluation principles

5.1 The basic principle of quality assessment of animal quarantine reagents for entry and exit is “scientific, fair, rigorous and efficient”. 5.2 The evaluation laboratory shall be authorized by the entry and exit animal quarantine authorities to meet the corresponding qualification requirements.

6 Evaluation procedures

6.1 Document review 6.1.1 The client shall provide the following materials. kit name, product manual, kit sensitivity and specific supporting materials, product details Operating procedures, and other supporting materials. 6.1.2 Formal review. A formal review of the authenticity and integrity of the materials provided by the client. Complete material access to the laboratory evaluation process Preface, materials are incomplete and need to complete the material.

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