GB/T 19634-2021In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing (English PDF)

Foreword

GB/T 19634 "In vitro diagnostic test systems - General technical requirements for

blood-glucose monitoring systems for self-testing" is not equivalent to ISO 15197.

This Standard was proposed by China Food and Drug Administration.

This Standard shall be under the jurisdiction of the National Clinical Trial Laboratory

and in-Vitro Diagnostic System Standardization Technical Committee.

Drafting organizations of this Standard. Beijing Institute of Medical Device Testing, and

American Johnson & Johnson Ltd.

Main drafters of this Standard. Hu Dongmei, Xu Yong, and John Mahoney.

Introduction

Blood-glucose monitoring systems for self-testing are in vitro diagnostic medical

devices used mainly by lay persons. When used properly, they can help diabetics to

monitor and take action to control the glucose concentration in the blood.

The primary objectives of this Standard are to establish requirements for the design of

blood-glucose monitoring systems that can result in acceptable results when used by

lay persons on the premises that users have accepted certain training, devices have

been properly maintained and operated according to the calibration and quality control

procedures in instructions for use of manufacturers, and to specify procedures for

verifying the conformance of blood-glucose monitoring systems' indicators to this

Standard.

This Standard illustrates general technical requirements for blood-glucose monitoring

systems for self-testing, including the information provided by the manufacturer and

labels and instructions of blood-glucose monitoring systems for self-testing. Since the

self-testing systems are used by lay persons, the information provided by the

manufacturer shall be explicit and easily to be understood, for the convenience of users

to have self-testing according to the operation procedures correctly. At the same time,

it shall provide certain warnings or prompts, to guide the appropriate measures under

abnormal results. This Standard specifies the information provided by the

manufacturer in detail.

In vitro diagnostic test systems - General technical

requirements for blood-glucose monitoring systems for

self-testing

1 Scope

This Standard specifies the terms and definitions, requirements, test methods, labels

and instructions for use, packaging, transportation, and storage for blood-glucose

monitoring systems for self-testing.

This Standard is applicable to the blood-glucose monitoring systems for self-testing

intended for in vitro monitoring the glucose concentration in capillary whole blood

and/or venous whole blood (normally including portable glucose meters, disposable

test strips, and control materials).

2 Normative references

The provisions in following documents become the provisions of this Standard through

reference in this Standard. For dated references, the subsequent amendments

(excluding corrigendum) or revisions do not apply to this Standard, however, parties

who reach an agreement based on this Standard are encouraged to study if the latest

versions of these documents are applicable. For undated references, the latest edition

of the referenced document applies.

GB 4793.1-1995 Safety requirements for electrical equipment for measurement,

control and laboratory use – Part 1.General requirements (idt IEC1010-1.1990)

GB 9706.1-1995 Medical electrical equipment – Part 1.General requirements for

safety (idt IEC 601-1.1988)

GB/T 14710-1993 Environmental requirements and testing methods for medical

electrical equipment

YY 0466-2003 Medical electrical equipment – Symbols for electrical equipment for

label, mark and providing information (ISO 15223.2000, IDT)

3 Terms and definitions

The following terms and definitions apply to this Standard.

[ISO 3534-1.1993, Definition 3.14]

Note 1.The precision degree is expressed in numerical form of the measurement imprecision obtained

by statistical measures, such as standard deviation (SD) and coefficient of variation (CV), that shows

a negative correlation with precision. Quantitative measures of precision depend on the specified

conditions.

Note 2.Precision of a given measurement procedure can be classified according to the clear precision

conditions. Precision under specific conditions are termed as "repeatability" and "reproducibility".

3.5

Repeatability

Consistency between test results obtained with continuous multiple measurements

under the same measurement conditions.

[JJF 1001-1998, Definition 5.6]

3.6

Repeatability conditions

Conditions where independent test results are obtained with the same test method, on

same test object, in the same laboratory, by the same operator, using the same

equipment, and within short intervals of time.

[ISO 3534-1.1993, Definition 3.16]

Note. Essentially constant conditions, intended to represent conditions resulting in test results of

minimum variability.

3.7

Blood-glucose meter

Component of a blood-glucose monitoring system, it can convert the result of a

chemical reaction into the glucose concentration in the sample.

3.8

Label

Printed, written or graphic information placed on a device or container.

3.9

Instructions for use

( > 75 mg/dL)

5 Test method