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GB/T 19634-2021 English PDF

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Q: Should I purchase the latest version GB/T 19634-2021?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 19634-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 19634-2021: In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testing
Status: Valid

GB/T 19634: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 19634-2021	279	Add to Cart	3 days	In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testing	Valid
GB/T 19634-2005	125	Add to Cart	Auto, < 3 mins	[Including 2006XG1] In vitro diagnostic test systems -- General technical requirement for blood-glucose monitoring systems for self-testing	Obsolete

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Basic data

Standard ID: GB/T 19634-2021 (GB/T19634-2021)
Description (Translated English): In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testing
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C44
Word Count Estimation: 14,195
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 19634-2021: In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testing

---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.
In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testing ICS 11.100 CCSC44 National Standards of People's Republic of China Replace GB/T 19634-2005 In Vitro Diagnostic Test System General technical conditions of blood glucose monitoring system for self-test (ISO 15197.2013,Invitrodiagnostictestsystems-Requirementsfor melitus, NEQ) Released on 2021-10-11 and implemented on 2023-05-01 State Administration of Market Supervision and Administration Issued by the National Standardization Management Committee

Foreword Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements 3 5 Test method 5 6 Labels and instructions for use 9 7 Packaging, transportation and storage 9 Reference 10

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" Drafting. This document replaces GB/T 19634-2005 "General technical conditions for blood glucose monitoring systems for self-testing in vitro diagnostic test systems", and Compared with GB/T 19634-2005, in addition to editorial changes, the main technical changes are as follows. ---Added the non-applicable scope (see Chapter 1); ---Modified the normative reference documents (see Chapter 2, Chapter 2 of the.2005 edition); ---In terms and definitions, the definition of "self-test" has been added (see 3.1), and "accuracy", "precision", "repeatability", "batch", and "label" have been modified Definition (see 3.9, 3.10, 3.11, 3.13, 3.16, 3.1, 3.4, 3.5, 3.8, 3.12 in the.2005 edition); ---Modified the "accuracy of blood glucose meter and blood glucose test strip system" requirements, modified the test range and allowable deviation (see 4.3,.2005 edition 4.3); ---Added hematocrit requirements (see 4.4); ---Modified the safety requirements for blood glucose meters (see 4.8, 4.7 of the.2005 edition); ---Added the electromagnetic compatibility requirements for blood glucose meters (see 4.9); ---Modified the requirements for blood glucose samples in the accuracy test of the blood glucose meter and blood glucose test strip system (see Table 5, Table 4 of the.2005 edition); ---Added the hematocrit test method (see 5.5); ---Modified the safety test method of blood glucose meter (see 5.9, 5.8 in.2005 edition); ---Added the electromagnetic compatibility test method (see 5.10); ---Modified the labeling and instruction manual requirements (see Chapter 6, Chapter 6 of the.2005 edition). This document refers to ISO 15197.2013 ``In vitro diagnostic testing system blood glucose monitoring system for self-testing in the management of diabetes "Requirements" are drafted, and the degree of consistency is non-equivalent. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed by the State Drug Administration. This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this document. Beijing Medical Device Inspection Institute, Beijing Huayi Jingdian Biotechnology Co., Ltd., Sannuo Biosensing Co., Ltd. Co., Ltd., Hunan Medical Device Inspection and Testing Institute, Roche Diagnostics (Shanghai) Co., Ltd., Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd., Guilin Unitech Medical Electronics Co., Ltd. The main drafters of this document. Xu Yong, Song Wei, Zhao Guangyu, Zhou Qian, Cao Li, Tian Wei, Jin Liang, Li Qiuping. The previous versions of this document and the documents replaced are as follows. ---First published as GB/T 19634-2005 in.2005; ---This is the first revision.

Introduction

The blood glucose monitoring system for self-test is mainly an in vitro diagnostic medical device used by non-professionals, which can be convenient when used correctly Diabetic patients monitor and take measures to control the concentration of glucose in the blood. The main purpose of this document is to ensure that the user has received appropriate training, the instrument has been properly maintained, and the manufacturer’s instructions have been followed. Under the premise of the operation of the calibration and quality control procedures, it is established that the blood glucose monitoring system designed for use by non-professionals can be acceptable The result requirements also stipulate the procedures for verifying the compliance with the performance standards of the blood glucose monitoring system. In Vitro Diagnostic Test System General technical conditions of blood glucose monitoring system for self-test

1 Scope

This document specifies the terms and definitions, requirements, test methods, labels and instructions for use, packaging, and transportation of blood glucose monitoring systems for self-testing. And storage. This document is applicable to the self-testing blood glucose monitoring system for monitoring the glucose concentration in human capillary blood in vitro (usually including portable Blood glucose meters, disposable test strips and quality control substances). This document does not apply to. ---Determination of blood glucose concentration for the purpose of diagnosing diabetes; ---Measurement procedures with graded measurement values (such as visual semi-quantitative measurement procedures), non-invasive blood glucose monitoring system, continuous blood glucose monitoring system.

2 Normative references

The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to This document. GB/T 191 Packaging, storage and transportation pictorial signs GB/T 14710 Environmental requirements and test methods for medical electrical appliances GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use-Part 1.General requirements GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 26.Special requirements External diagnostic (IVD) medical equipment GB/T 29791.4 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 4.In vitro diagnostic reagents for self-testing GB/T 29791.5 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 5.In vitro diagnostic devices for self-testing

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Self-testing A test performed by a non-professional to assess the health of an individual. Note. Usually the inspection is carried out at home or in other places outside the medical institution, without the guidance of professional medical staff. [Source. GB/T 29791.1-2013, 3.65] 3.2 Non-professional layperson Individuals who have not received formal training in related fields or disciplines. Note. In this document, users of blood glucose monitoring systems refer to people who do not have special medical, scientific or technical knowledge related to blood glucose monitoring. [Source. GB/T 29791.1-2013, 3.34] ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 19634-2021_English be delivered?

Answer: Upon your order, we will start to translate GB/T 19634-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 19634-2021_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 19634-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version GB/T 19634-2021?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 19634-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.