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YY/T 1838-2022 English PDF

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YY/T 1838-2022: Disposable capillary blood collection device
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PDF similar to YY/T 1838-2022


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Basic data

Standard ID YY/T 1838-2022 (YY/T1838-2022)
Description (Translated English) Disposable capillary blood collection device
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Word Count Estimation 12,138
Issuing agency(ies) State Drug Administration

YY/T 1838-2022: Disposable capillary blood collection device

---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.
Disposable capillary blood collection device ICS 11.040.10 CCSC30 People's Republic of China Pharmaceutical Industry Standard Disposable peripheral blood collection device Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration

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. Please note that some content of this document may be patented. Publication of this document Institutions do not assume responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Infusion Devices (SAC/TC106). This document is drafted by. Tianjin Huahong Technology Co., Ltd., Shandong Medical Device Product Quality Inspection Center, Suzhou Shilai Medical Equipment Co., Ltd., Bidi Medical Equipment (Shanghai) Co., Ltd., Tianjin Medical Equipment Review and Inspection Center. The main drafters of this document. Zhang Libo, Sun Jianjun, Shi Guoping, Zhou Tingli, Dong Meicheng, Jia Yufei, Sun Juanjuan, Wang Ying, Chen Yong, Han Naishui.

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". The "movable lancing device" must be used in conjunction with the lancing pen, and the other two can be used independently (see 4.1). Disposable peripheral 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. 3.1 blood collection device bloodcolectiondevice Instruments for puncturing or cutting for peripheral blood collection. 3.2 puncturecomponents Parts or components used for puncturing or cutting human peripheral blood vessels. 3.3 Needlebase A part or component attached to the other end of the piercing or cutting site of the piercing member. 3.4 Primary package primarypackage Packaging that is in direct contact with the product. 3.5 single package unitpackage Packaging of a single product, a set of process-related components, or a series of products supplied as a set. It is the basic unit of product sales. [Source. YY/T 0313-2014, Definition 3.3, with modifications] 3.6 lancingdevice The launch device used with the blood collection device can be pen-shaped or non-pen-shaped, and can be reused.

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