YY/T 1838-2022Disposable capillary blood collection device (English PDF)

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 of Standardization Documents" drafted.

Introduction

Peripheral blood is mainly used for complete blood cell analysis, blood type, blood sugar, erythrocyte sedimentation rate, and newborn screening. With the development of laboratory medicine technology With the continuous development and improvement of modernization, micro-quantification and facilitation, some projects that used a large amount of blood in the past have also established rapid micro-quantification methods, such as micro-quantification methods.

Elements, infectious markers, antibodies to infectious diseases, and point-of-care testing items, etc., the clinical application of peripheral blood has broad prospects. corresponding Yes, the demand for peripheral blood collection devices will also increase.

There are many kinds of peripheral blood collection devices, and the material structure is also different. At present, there is no universal international standard in the world, and most countries have also There are no industry standards and national standards. At present, the peripheral blood collection device and the blood collection pen are generally supplied separately on the market, and the two can be used as two types of products.

Register individually. There are three types of common blood collection devices. "hand-held blood collection device", "semi-automatic blood collection device" and "automatic blood collection device".

1 Scope

This document specifies the product classification, requirements, test methods, signs, packaging, Transportation and storage.

This document applies to lancing devices that puncture the skin to collect peripheral blood samples from humans.

2 Normative references

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

GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process

GB/T 18457-2015 Manufacturing of stainless steel needle tubes for medical devices

YY 0174-2019 Surgical blade

YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1: General Requirements

3 Terms and Definitions

The following terms and definitions apply to this document.