SN/T 3509-2013Guidelines for samples management in laboratory (English PDF)

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. Beijing Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, Shandong Entry and Exit Inspection of the People's Republic of China Epidemic situation.

Introduction

This standard mainly refers to the ORA laboratory procedure document issued by the US Food and Drug Administration, "5.8 Sample Management" (FDA, ORALaboratoryManual, ORA-LAB.5.8 Sample Management) and Volume 3 Part 2, Sample Management Application Ming (FDA, ORALabManual, Volume III, Section 2-ChainofCustody-SampleHandling).

The expression of this standard follows the general requirements of GB/T 27025, "Testing and Calibration Laboratory Capabilities", 5.8 Testing and calibrating items (like the requirements for the disposal of the product, this standard is applicable to the acceptance, identification and protection of the test and calibration laboratory samples in various fields of the inspection and quarantine system.

The application details for deposit, transfer and disposal are the guiding documents for sample management in the laboratory. At the same time, taking into account the differences between the fields of inspection and quarantine Special requirements for heterogeneity, the laboratory may formulate laboratory internal procedures or work instructions in accordance with this standard to supplement this standard.

Charge, but it should not include additional general requirements not included in this standard.

Laboratory Sample Management Guide

1 Scope

This standard specifies the requirements for receipt, identification, storage, transfer and disposal of laboratory samples.

This standard applies to laboratory sample receiving and storage management.

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.

GB/T 27405 Laboratory Quality Control Specification Food Microbial Testing

3 Terms and definitions

The following terms and definitions as defined in GB/T 27405 apply to this document. For ease of use, the following is a list of GB/T 27405 Related terms and definitions.

Sample

The laboratory is used for inspection, taken from one or more parts of a whole, to provide relevant information about the whole, usually as a judgment the overall foundation.

Subsample samplesubmittedforstorageonly the inspection agency submitted by the customer shall not be used to test the sample used only for sample retention, and shall be confirmed by the customer to be homogeneous with the sample.

Product, if necessary, as a reference, retest or arbitration review.

Keep sample reservesample the laboratory prepares samples for the original characteristics of the sample while preparing samples in the laboratory for the purpose of sample backup.

When there is no secondary sample, the sample can be retained for review, retest or arbitration.

4 Management requirements