GB/T 29791.4-2013 English PDF

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GB/T 29791.4-2013: In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 29791.4-2013	234	Add to Cart	3 days	In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing	Valid

Similar standards

GB/T 29791.3   GB/T 26124   GB/T 21415   GB 19083   GB/T 29791.5   GB/T 29791.1   

Basic data

Standard ID: GB/T 29791.4-2013 (GB/T29791.4-2013)
Description (Translated English): In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 12,150
Quoted Standard: ISO 14971; ISO 15223-1; ISO 18113-1; EN 980
Adopted Standard: ISO 18113-4-2009, IDT
Regulation (derived from): National Standards Bulletin No. 21 of 2013
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies the self-test in vitro diagnostic (IVD) reagent manufacturers to provide information on request. This standard also applies to the self-test is expected to be used in conjunction with in vitro diagnostic medical devices calibrator,

GB/T 29791.4-2013: In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents 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 medical devices Information supplied by the manufacturer (labelling) Part 4. In vitro diagnostic reagents for selftesting ICS 11.100 C44 National Standards of People's Republic of China In vitro diagnostic medical device manufacturers to provide information (labeling) Part 4. In vitro diagnostic reagents for self manufacturer (labeling) -Part 4. Invitrodiagnosticreagentsforselftesting (ISO 18113-4.2009, IDT) Issued on. 2013-10-10 2014-03-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Foreword

GB/T 29791 "in vitro diagnostic medical devices - Information supplied by the manufacturer (labeling)" is divided into five parts. --- Part 1. Terms, definitions and general requirements; --- Part 2. In vitro diagnostic reagents for professional use; --- Part 3. In vitro diagnostic instruments for professional use; --- Part 4. In vitro diagnostic reagents for self; --- Part 5. In vitro diagnostic instruments for self. This section GB/T Part of 429,791. This section drafted in accordance with GB/T 1.1-2009 given rules. This section uses the translation method identical with ISO 18113-4.2009 "in vitro diagnostic medical device manufacturers to provide information (labeling) Part 4. In vitro diagnostic reagents "for self. Consistency correspondence between this part of international documents and normative references of our files are as follows. --- YY/T 0316-2008 medical device risk management to medical devices applications (ISO 14971.2008, IDT) Symbols - Part 1 --- YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information provided. pass With requirements (ISO 15223-1.2007, IDT) Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This part is proposed by the State Food and Drug Administration. This part of the National Medical clinical testing laboratory and in-vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This section is drafted. Beijing Medical Device Testing. The main drafters of this section. Bi Chunlei, Duhai Ou.

Introduction

Self-test (IVD) reagents supplied by the manufacturer to the user is able to use safety equipment and achieve its expected performance in vitro diagnostic information. its The form and level of detail as the intended use and the country-specific regulations vary. Global Harmonization Task Force (GHTF) encourages global regulatory system for medical devices to converge. Eliminate differences between jurisdictions and regulations can be So patients earlier access to new technologies and treatments, see reference [9]. This section provides coordination for self labeling requirements for IVD reagent basis. This section is only concerned about the IVD reagent is expected to use the self-test, calibrators and control materials information provided. This section is intended and GB/T 29791.1 used in combination, the standard contains the definition of common requirements for the information provided by the manufacturer and marked general concepts. This section based on EN376.2002 [5]. In order to comply with ISO /IEC Guide Part 2 [4], the text has been modified, but the requirements, including Enclosed in GB/T 29791.1 requirements substantially identical with the initial harmonized European standards. This section is intended to support all GHTF participating countries, And basic labeling requirements in other countries are implementing or planning to implement IVD medical device labeling regulations. As expected for IVD reagent systems and equipment supplied by the same manufacturer used together, calibrators and (or) controlled substances, present Section also expected with GB/T 29791.1 and GB/T 29791.5 used together. In vitro diagnostic medical device manufacturers to provide information (labeling) Part 4. In vitro diagnostic reagents for self

1 Scope

This section GB/T 29791 provides for self-test use in vitro diagnostics (IVD) reagent manufacturer's information requirements. This section also applies to self-test and is expected to be used in conjunction with in vitro diagnostic medical devices calibrator, control material manufacturer's information. This section also applies to IVD Annex. This section applies to outer and inner packaging label and instructions for use. This section does not apply to. a) in vitro diagnostic instruments or equipment; b) in vitro diagnostic reagents for professional use.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. ISO 14971 Medical Device Risk Management for Medical Device Applications (Medicaldevices-Applicationofriskman- agementtomedicaldevices) Symbols - Part 1 ISO 15223-1 for medical equipment with medical device labels, labeling and information. General requirements (Medicaldevices-Symbolstobeusedwithmedicaldevicelabels, labelingandinformationtobesup- plied-Part 1. Generalrequirements) ISO 18113-1 In vitro diagnostic medical device manufacturers to provide information (labeling) - Part 1. Terms, definitions and general requirements (Invitrodiagnosticmedicaldevices-Informationsuppliedbythemanufacturer (labeling) -Part 1. Terms, definitionsandgeneralrequirements) EN980 medical devices used in the labeling symbol (Symbolsforuseinthelabelingofmedicaldevices)

3 Terms and Definitions

Terms and definitions defined in ISO 18113-1 apply to this document.

4 General

4.1 Basic requirements ISO 18113-1 apply. For the use of symbols, ISO 15223-1 and EN980 requirements apply. International standards specific IVD medical device manufacturers may also contain requests for information. Example. ISO 15197 [1]; ISO 17593 [2]. 4.2 Identification kit components For kits, every component in all labels and instructions for use should be the same way with names, letters, numbers, symbols, colors ......

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