GB/T 43286-2023Disposable sampling tube (inactivated type) (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.

Introduction

The effective collection of biological samples containing pathogenic microorganisms, especially viruses, is very important for later nucleic acid detection. One-time collection Sample tubes (inactivated type) are an important product for collecting biological samples. Effective inactivation of viruses in biological samples can reduce sample processing and Biosafety risks during the detection process; at the same time, the nucleic acid contained in the biological sample in the sampling tube maintains sufficient stability and integrity within a certain period of time Capable of providing biological samples that meet nucleic acid testing requirements. Therefore, in order to standardize sampling tube products, this document covers disposable sampling tubes (inactivated type)

Standardized specification requirements are carried out with the purpose of providing standard reference for production enterprises and quality supervision departments.

1 Scope

This document specifies the requirements, test methods, inspection rules, labeling, packaging, transportation and storage of disposable sampling tubes (inactivated type).

This document applies to disposable sampling tubes for collecting biological samples (hereinafter referred to as "sampling tubes").

Note: Sampling tubes are used to store biological samples collected from nasal swabs, throat swabs and environmental swabs, and to inactivate viruses in biological samples to meet the requirements of the collected biological samples. Detection of viral nucleic acids in samples.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 191 Packaging, storage and transportation pictorial mark

GB/T 2828.1-2012 Enumeration sampling inspection procedures Part 1: Batch-by-batch inspection sampling retrieved by acceptance quality limit (AQL) plan

GB/T 9969 General Principles of Instructions for Use of Industrial Products

GB/T 37875 Technical specifications for quality evaluation of nucleic acid extraction and purification kits

GB 41918-2022 Biological safety cabinet

YY/T 0242 Special polypropylene materials for medical infusion, blood transfusion and injection equipment

3 Terms and definitions

The following terms and definitions apply to this document.