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YY/T 1454-2016General requirements for in vitro diagnostic medical devices for self-testing (English PDF)

自我检测用体外诊断医疗器械基本要求

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1454-2016 is the English-translated version of 自我检测用体外诊断医疗器械基本要求.

YY/T 1454-2016 is the Chinese pharmaceutical industry standard that sets the general requirements for in vitro diagnostic medical devices intended for self-testing.

It fixes the principles by which such a device is designed, the marking and the information the manufacturer must provide to a lay user, the performance evaluation to be carried out and the user verification by which it is shown that a lay person can obtain a correct result from the device and understand it. Issued on 26 January 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1454-2016

National Standard of the People's Republic of China

ICS: 11.100
Classification: C 30

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative reference documents
3 Terms and definitions

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the self-test (hereinafter referred to as self-test) with in vitro diagnostic medical device design principles, manufacturers provide the mark and letter Interest, performance evaluation, user authentication, etc.

This standard applies to self-examination in vitro diagnostic medical equipment.

This standard does not apply to medical characteristics of self-test in vitro diagnostic medical devices.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements

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. Particular requirements External diagnostic (IVD) medical equipment

GB/T 29791.1-2013 Information provided by manufacturers of in vitro diagnostic medical device (marking) Part 1.

GB/T 29791.4 Information provided by manufacturers of in vitro diagnostic medical devices (Labeling) - Part 4. In vitro diagnostic reagents for self-test

GB/T 29791.5 Information provided by manufacturers of in vitro diagnostic medical devices (Labeling) - Part 5. In vitro diagnostic instruments for self-test GB/T 29791.5

YY/T 1441 General requirements for in vitro diagnostic medical device performance evaluation

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 In vitro diagnostic medical device

IVD Medical Devices IVDmedicaldevice Used alone or in combination, is intended by the manufacturer to be used for in vitro examination of human body specimens, to test either simply or primarily to provide diagnosis, monitoring Or compatibility information for the purpose, the instrument includes reagents, calibrators, control substances, sample containers, software and related instruments or devices or other article. [GB/T 29791.1-2013 Definition 3.27]

3.2 Non - professional layperson

People who do not have a professional education background.

3.3 Mark

Permanently attached to medical instruments on the formation of words or graphic symbols. [GB/T 29791.1-2013 Definition 3.37]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 29791.4-2013|GB/T 29791.5-2013|YY/T 0639-2019|YY/T 1579-2018|YY/T 1441-2016|YY/T 0638-2008

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