GB/T 29791.2-2013In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use (English PDF)
体外诊断医疗器械 制造商提供的信息 标示 第2部分：专业用体外诊断试剂
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Issued by
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Level / Type
National · Recommended
Issue date
October 10, 2013
Implementation date
February 1, 2014
Scope
GB/T 29791.2-2013 is the English-translated version of 体外诊断医疗器械 制造商提供的信息 标示 第2部分：专业用体外诊断试剂.
GB/T 29791.2-2013 is the Chinese standard "In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use".
Its scope clause reads: This section GB/T 29791 specifies the professional use in vitro diagnostics (IVD) reagent manufacturer's information requirements. This section also applies to professional calibration was expected and in vitro diagnostic medical devices for use with controlled substance information provided by the manufacturer.
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) self-test in vitro diagnostic reagents. Its clauses include terms and definitions; general.
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Document preview — GB/T 29791.2-2013
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 General
- 4.1 Basic requirements
1 Scope
This section GB/T 29791 specifies the professional use in vitro diagnostics (IVD) reagent manufacturer's information requirements.
This section also applies to professional calibration was expected and in vitro diagnostic medical devices for use with controlled substance information provided by the manufacturer.
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) self-test in vitro diagnostic reagents.
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 8601 Data elements and interchange formats - Information interchange the date and time notation (Dataelementsandinterchange formats-Informationinterchange-Representationofdatesandtimes)
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. […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 8601 · ISO 14971 · ISO 15223 · ISO 18113
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Related Standards
GB/T 29791.1-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
GB/T 29791.3-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
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
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