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YY/T 1454-2016: General requirements for in vitro diagnostic medical devices for self-testing
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YY/T 1454-2016	English	139	Add to Cart	3 days [Need to translate]	General requirements for in vitro diagnostic medical devices for self-testing

YY/T 1454-2016: General requirements for in vitro diagnostic medical devices for self-testing

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General requirements for in vitro diagnostic medical devices for self-testing ICS 11.100 C30 People's Republic of China Pharmaceutical Industry Standard Self - examination in vitro diagnostic medical equipment basic requirements 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The standard drafting unit. Beijing Medical Device Testing Institute, Guilin You Li Te Medical Electronics Co., Ltd., Johnson & Johnson (Shanghai) medical equipment Limited, Roche Diagnostic Products (Shanghai) Co., Ltd. The main drafters of this standard. Zhang Hong, Zhou Yongqing, Zhuo Xiaofang, Tian Wei, Li Dan. Self - examination in vitro diagnostic medical equipment basic requirements

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 article Pieces. 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. terms, definitions and General requirements 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 invitrodiagnosticmedicaldevice 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 mark Permanently attached to medical instruments on the formation of words or graphic symbols. [GB/T 29791.1-2013 Definition 3.37] ...