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GB/T 29791.3-2013 English PDF (GBT29791.3-2013)

GB/T 29791.3-2013 English PDF (GBT29791.3-2013)

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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 29791.3-2013
In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use ICS 11.100
C44
National Standards of People's Republic of China
Information provided by IVD medical device manufacturers (labeling)
Part 3. In vitro diagnostic equipment for professional use
manufacturer (labeling) -Part 3. Invitrodiagnosticinstrumentsfor
professionaluse
(ISO 18113-3..2009, IDT)
2013-10-10 release
2014-02-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Published by China National Standardization Administration
Foreword
GB/T 29791 `` Information provided by manufacturers of in vitro diagnostic medical devices (labeling) ' is divided into 5 parts. --- Part 1. Terms, definitions and general requirements;
--- Part 2. In vitro diagnostic reagents for professional use;
--- Part 3. In vitro diagnostic equipment for professional use;
--- Part 4. In vitro diagnostic reagents for self-test;
--- Part 5. Self-test in vitro diagnostic equipment.
This part is the third part of GB/T 29791.
This section is drafted in accordance with the rules given in GB/T 1.1-2009. This section uses the translation method equivalent to ISO 18113-3..2009 "Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3. In vitro diagnostic equipment for professional use.
The Chinese documents that have a consistent correspondence with the international documents referenced normatively in this section are as follows. --- YY/T 0316-2008 Application of medical device risk management to medical devices (ISO 14971..2008, IDT) --- YY/T 0466.1-2009 Medical devices-Symbols used for labeling, marking and providing information of medical devices-Part 1. General Requirements (ISO 15223-1..2007, IDT)
--- GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 1. General requirements (IEC 61010-1..2001, IDT)
--- YY0648-2008 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 2-101. In vitro diagnostics (IVD) Specific requirements for medical equipment (IEC 61010-2-101..2002, IDT) Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This section is proposed by the State Food and Drug Administration.
This section is under the jurisdiction of the National Medical Clinical Laboratory Laboratory and the Standardization Technical Committee for In vitro Diagnostic Systems (SAC/TC136). This section was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this section. Bi Chunlei, Du Haiou.
introduction
Manufacturers of professional in vitro diagnostic (IVD) equipment provide information to users that enables them to safely use and achieve the expected performance of their devices. its The form and level of detail vary depending on the intended use and country-specific regulations. The Global Harmonization Task Force (GHTF) encourages a global consensus on medical device regulatory systems. Eliminating discrepancies between jurisdictions Make patients get new technology and treatment earlier, see reference [5]. This section provides guidelines for harmonizing the marking requirements of professional IVD instruments. basis.
This section focuses only on the information provided for IVD instruments and equipment intended for professional use. This section aims to align with GB/T 29791.1 For joint use, this section contains the general requirements for the information provided by the manufacturer and the definition of the universal labeling concept. This section is based on EN591 [3]. In order to comply with the ISO /IEC Guide Part 2 [2], the text has been modified, but the requirements, including The requirements in GB/T 29791.1 are basically equivalent to the original European harmonized standards. This section is intended to support all GHTF participating countries, and Basic labeling requirements in other countries that implement or plan to implement IVD medical device labeling requirements. For IVD instruments intended to be used as a system with reagents provided by the same manufacturer, this section also GB/T 29791.1 and GB/T 29791.2 are used together.
Information provided by IVD medical device manufacturers (labeling)
Part 3. In vitro diagnostic equipment for professional use
1 Scope
This part of GB/T 29791 specifies the requirements for information provided by professional in vitro diagnostic (IVD) instrument manufacturers. This section also applies to devices and equipment intended for use with professional in vitro diagnostic medical devices. This section also applies to IVD attachments.
This section does not apply to.
a) instructions for servicing or repairing the instrument;
b) in vitro diagnostic reagents, including calibrators and control substances used to control the reagents; c) In vitro diagnostic equipment for self-test.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. ISO 14971 Medical Device Risk Management for Medical Devices (Medicaldevices-Applicationofriskman- agementtomedicaldevices)
ISO 15223-1 Medical devices. Symbols for labelling, labelling, and providing information in medical devices. Part 1. General requirements (Medicaldevices-Symbolstobeusedwithmedicaldevicelabels, labelingandinformationtobesup- plied-Part 1. Generalrequirements)
Information from ISO 18113-1 manufacturers of in vitro diagnostic medical devices (labelling) Part 1. Terms, definitions and general requirements [Invitrodiagnosticmedicaldevices-Informationsuppliedbythemanufacturer (labeling) -Part 1. Terms, definitionsandgeneralrequirements]
IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 1. General requirements mentsforelectricalequipmentformeasurement, controlandlaboratoryuse-Part 1. Generalrequire- ments)
IEC 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 2-101. In vitro diagnostic (IVD) medical Special requirements for equipment used [Safetyrequirementsforelectricalequipmentformeasurement, controlandlabora- toryuse-Part 2-101. Particular requirements for invitrodiagnostic (IVD) medicalequipment] IEC 61326-2-6 Requirements for electromagnetic compatibility of electrical equipment for measurement, control and laboratory use-Part 2-6. Special requirements Diagnostic (IVD) medical equipment [Electricalequipmentformeasurement, controlandlaboratoryuse-EMCre- quirements-Part 2-6. Particular requirements-Invitrodiagnostic (IVD) medicalequipment] IEC 62366 Medical Device-Application of Medical Devices
usabilityengineeringtomedicaldevices)
EN980 Symbols for use in the labeling of medical devices
3 terms and definitions
The terms and definitions defined in ISO 18113-1 apply to this document. 4 Basic requirements
The requirements of ISO 18113-1 apply.
5 Labels and tags
5.1 General
The requirements of IEC 61010-1, IEC 61010-2-101 and IEC 61326-2-6 regarding labels and markings apply. For the use of symbols, the requirements of ISO 15223-1 and EN980 apply. 5.2 Identification of IVD instruments
5.2.1 IVD Instrument Name
The name of the IVD instrument should be given.
When the name cannot uniquely identify the IVD instrument, an additional identification method should also be given. Example. catalog number, product code.
5.2.2 Serial number
The IVD instrument should be given a unique serial number.
All instruments covered by the IEC 61010 series of standards require serial numbers. When the serial number of the device, equipment or accessory used with the IVD instrument is not suitable, the batch number can be used instead. Example. The original sample container is assigned a lot number.
5.2.3 In vitro diagnostic uses
The instrument's in vitro diagnostic use should be indicated when required by regulations. Example. "For in vitro diagnostic use" or graphic symbol. "In vitro diagnostic medical device". 6 Elements of instructions
Where appropriate, the instructions for use of professional instruments should include the following. a) directory;
b) overview of operational elements;
c) diagram of instrument structure;
d) synthesis and arrangement of texts and diagrams;
e) pictorial emphasis of warnings;
f) examples of how to use the instrument;
g) a diagram of the operation steps;
h) list of accessories;
i) relevant scientific references;
j) index;
k) Version control identification and date of first use.
Electronically searchable instrument guides do not require a catalog or index. The information provided by in vitro diagnostic instruments should at least cover. safety, installation and environmental requirements. 7 Contents of the instructions
7.1 Manufacturer
The name and address of the manufacturer shall be given.
Note. In the European Union, if the legal manufacturer is not located in the European Union, the name and address of the manufacturer's "EU Authorized Representative" should be given, see reference [4]. 7.2 Identification of IVD instruments
7.2.1 Name of IVD instrument
The name of the IVD instrument should be given.
When the name cannot uniquely identify the IVD instrument, an additional identification method should also be given. Examples. catalog number, product code.
7.2.2 Module and software identification
Individual instrument modules and/or software shall be identified by name and version (where applicable). 7.3 Intended use
The intended use of the in vitro diagnostic device should be described. Example. Use the reagents and calibrants expected for this instrument to measure analytes in biological raw samples. Where appropriate, the benefits and limitations of the intended use of in vitro diagnostic medical devices should be stated. 7.4 Storage and handling
Any instructions regarding special environmental requirements, handling and/or storage conditions should be provided. 7.5 Warnings and precautions
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