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GB/T 18268.26-2010 English PDF (GBT18268.26-2010)

GB/T 18268.26-2010 English PDF (GBT18268.26-2010)

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GB/T 18268.26-2010: Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 26: Particular requirements -- In vitro diagnostic (IVD) medical equipment

GB/T 18268.26-2010
Electrical equipment for measuremen, control and laboratory use.EMC requirements.Part 26. Particular requirements.In vitro diagnostic (IVD) medical equipment ICS 25.040.40; 33.100; 17.220
N10
National Standards of People's Republic of China
Electrical equipment for measurement, control and laboratory use
Electromagnetic compatibility requirements-Part 26. Special requirements In vitro diagnostic (IVD) medical devices
Electricalequipmentformeasurement, controlandlaboratoryuse-
EMCrequirements-Part 26. Particularrequirements-
Invitrodiagnostic (IVD) medicalequipment
(IEC 61326-2-6..2005, IDT)
Published on January 14,.2011
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Published by China National Standardization Administration
Foreword
GB/T 18268 "Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use" consists of --- Part 1. General requirements
--- Part 21. Special requirements for test configuration and working conditions of sensitivity testing and measuring equipment for electromagnetic compatibility-free protection And performance criteria
--- Part 22. Special requirements for test configurations, working conditions and test equipment for portable test, measurement and monitoring equipment for low-voltage power distribution systems Performance criteria
--- Part 23. Special requirements for test configurations, operating conditions and performance criteria with integrated or remote signal conditioning transmitters --- Part 24. Special requirements for insulation monitoring devices in accordance with IEC 61557-8 and insulation fault determination in accordance with IEC 61557-9 Test equipment, operating conditions and performance criteria
--- Part 25. Special requirements for test configurations, working conditions and performance of field devices with interfaces in accordance with IEC 61784-1, CP3/2 Criterion
--- Part 26. Special requirements for in vitro diagnostic (IVD) medical devices --- Part 31. Immunity requirements for equipment performing or preparing to perform safety functions (functional safety) General industrial applications --- Part 32. Immunity requirements for equipment performing or preparing to perform safety functions (functional safety) specify in an electromagnetic environment Industrial applications
This part is Part 26 of GB/T 18268.
This section is equivalent to IEC 61326-2-6..2005 (English version).
This section is based on GB/T 1.1-2000 "Guidelines for Standardization Work Part 1. Standard Structure and Rules for Writing" and The relevant provisions of GB/T 20000.2-2001 "Standardization Work Guide Part 2. Rules for Adopting International Standards" modify.
--- Removed the preface and introduction of international standards;
--- "This part of IEC 61326" was changed to "this part of GB/T 18268";
--- The guideline of the original reference file is changed to the guideline of the normative reference file according to the provisions of GB/T 1.1-2000; --- Normative references have been added to the reference documents appearing in Table 1 and Chapter 9 GB/T 17626.2, GB/T 17626.3, GB/T 17626.4, GB/T 17626.5, GB/T 17626.6, GB/T 17626.8, GB/T 17626.11, and GB 4824;
--- Replace the comma "," with a decimal point "." As a decimal point.
In the international standards adopted in this section, the additional contents of each chapter have adopted special numbers, such as 3.101, 3.102, etc., to show the difference. Jian In this section, international standards are equivalently adopted. In order to be consistent with international standards, this section has not changed. This section is proposed by China Machinery Industry Federation.
This section is under the jurisdiction of the National Industrial Process Measurement and Control Standardization Technical Committee (SAC/TC124). This section is responsible for drafting. Shanghai Institute of Industrial Automation Instrumentation. This section participated in the drafting unit. Shanghai Instrumentation Automatic Control System Inspection and Testing Institute, Fujian Shangrun Precision Instrument Co., Ltd. The main drafters of this section. Wang Ying, Ge Jian, Li Minghua, and Hong Jizhen. This section is the first release.
Electrical equipment for measurement, control and laboratory use
Electromagnetic compatibility requirements-Part 26. Special requirements In vitro diagnostic (IVD) medical devices
1 Scope
The scope of GB/T 18268.1 applies to this part. In addition, this part of GB/T 18268 is based on the characteristics of in vitro diagnostic medical devices And its electromagnetic environment, the basic requirements for immunity and emission of electromagnetic compatibility are specified. 2 Normative references
The clauses in the following documents become clauses of this section after being referenced in this part of GB/T 18268. All quotes with date Documents, all subsequent amendments (excluding errata) or revisions are not applicable to this section, however, The parties to the agreement investigate whether the latest versions of these documents are available. For undated references, the latest edition applies In this section.
GB/T 4365-2003 Electromagnetic Terms for Electromagnetic Compatibility (IEC 60050-161..1990, IDT) GB 4824 Limits and measurement methods for electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment (GB 4824-2004, (CISPR11..2003, IDT)
GB/T 17626.2 Electromagnetic compatibility test and measurement technology Electrostatic discharge immunity test (GB/T 17626.2-2006, (IEC 61000-4-2..2001, IDT)
GB/T 17626.3 Electromagnetic compatibility test and measurement technology Radio frequency electromagnetic field radiation immunity test (GB/T 17626.3- 2006, IEC 61000-4-3..2002, IDT)
GB/T 17626.4 Electromagnetic compatibility test and measurement technology Electrical fast transient pulse group immunity test (GB/T 17626.4- 2008, IEC 61000-4-4..2004, IDT)
GB/T 17626.5 Electromagnetic compatibility test and measurement technology Surge immunity test (GB/T 17626.5-2008, (IEC 61000-4-5..2005, IDT)
GB/T 17626.6 Electromagnetic Compatibility Test and Measurement Technology, Immunity to Conducted Disturbances Induced by Radio Frequency Field (GB/T 17626.6- 2008, IEC 61000-4-6..2006, IDT)
GB/T 17626.8 Electromagnetic compatibility test and measurement technology Power frequency magnetic field immunity test (GB/T 17626.8-2006, (IEC 61000-4-8..2001, IDT)
GB/T 17626.11 Electromagnetic compatibility test and measurement technology Immunity test for voltage sags, short interruptions and voltage changes (GB/T 17626.11-2008, IEC 61000-4-11..2004, IDT)
GB/T 18268.1-2010 Requirements for electromagnetic compatibility of electrical equipment for measurement, control and laboratory use. Part 1. General requirements (IEC 61326-1..2005, IDT)
ISO 14971..2000 Application of Medical Device Risk Management in Medical Devices 3 terms and definitions
GB/T 18268.1 and GB/T 4365 established the following terms and definitions apply to this section. 3.1
In vitro diagnostic medical equipment
Devices and equipment for diagnosing a disease or other purpose, including determining a medical condition to treat, reduce pain, treat or prevent a disease Home. Such instruments and devices are mainly used to collect, prepare and inspect samples taken from the human body. 4 General
Chapter 4 of GB/T 18268.1 is applicable to this part, and the following contents are attached. 4.101 Electromagnetic environment of IVD medical equipment
Like conventional medical electrical equipment, in vitro diagnostic medical equipment is widely used in various electromagnetic environments. In vitro diagnostic medical equipment except In addition to working normally in a typical health care environment (hospital, clinic, doctor's office), it should also work normally and safely in a home environment Make. This means that such equipment should have a basic immunity level suitable for these environments. Equipment used in other environments (for example, ambulances, aircraft, cars, or helicopters) may require a higher level of immunity to ensure that Ensure the safety and effectiveness of equipment performance.
5 EMC test plan
5.1 General
GB/T 18268.1-2010 5.1 applies to this section.
5.2 Configuration of the equipment under test
5.2.1 General
GB/T 18268.1-2010 5.2.1 applies to this section.
5.2.2 Composition of the equipment under test
GB/T 18268.1-2010 5.2.2 applies to this section.
5.2.3 Combination of test equipment
GB/T 18268.1-2010 5.2.3 applies to this section.
5.2.4 I/O Port
GB/T 18268.1-2010 5.2.4 applies to this section.
5.2.5 Auxiliary equipment
GB/T 18268.1-2010 5.2.5 applies to this section.
5.2.6 Cable connection and ground
GB/T 18268.1-2010 5.2.6 applies to this section.
5.3 Working conditions of the equipment under test during the test
GB/T 18268.1-2010 5.3 applies to this section, and the following are attached. 5.3.101 Working conditions
The operating conditions of the equipment shall be set according to the manufacturer's specifications. When there are different input power modes (for example, optional battery or AC power supply), the manufacturer should specify the Operating mode, which should cover the most adverse working conditions. 5.4 Performance criteria
GB/T 18268.1-2010 5.4 applies to this section.
5.5 Test description
GB/T 18268.1-2010 5.5 applies to this section.
6 Immunity requirements
6.1 Test conditions
In addition to the following, GB/T 18268.1-2010 6.1 applies to this section. The test report shall accurately record the configuration and working mode during the test. The test shall be applied to the relevant ports specified in Table 1.
The test shall be performed in accordance with the provisions of the basic standards of GB/T 17626 series. Each test shall be performed separately. Other tests if needed Methods, test methods and principles should be recorded.
6.2 Immunity test requirements
The following replaces 6.2 of GB/T 18268.1-2010.
6.2.101 Risk assessment and EMC immunity requirements
In some environments, high-power electromagnetic emission sources can cause nearby medical equipment to malfunction. Different types of medical electrical equipment are Different failure risk levels. Because IVD medical devices are not used for patient life support or resuscitation, malfunctions do not directly cause patient death or severely injured. Malfunctions in IVD medical electrical equipment may cause erroneous indications, leading to erroneous medical diagnosis (misdiagnosis). for Some analytes and in some cases, wrong conclusions can cause serious harm to patients. For large IVD medical equipment, electricity Magnetic disturbances can also cause malfunctions that directly threaten the operator, for example, unexpected mechanical movements. Guidance on direct hazard risk assessment is provided in ISO 14971. Guidance for assessing risks to patients from incorrect findings Annex H of ISO 14971..2000.
Note. Generally, conclusions made by IVD medical devices are checked by medical personnel for their credibility, or further decisions are made by health care professionals. For ordinary users Self-tested IVD medical devices often recommend actions to be taken without a clear conclusion. Users are required to contact their doctor before making a decision. The risks of using IVD medical devices are similar to those of non-life-supporting medical devices. Therefore, the immunity test given in Table 1 requires The requirements are similar to those for non-life-supporting medical devices. Table 1 Minimum immunity requirements for in vitro diagnostic (IVD) medical devices Port test item EMC basic standard test value
shell
Electrostatic discharge (ESD) GB/T 17626.2
Air discharge. 2kV, 4kV, 8kV,
Contact discharge. 2kV, 4kV
Radiated electromagnetic field GB/T 17626.3 3V/m, 80MHz ~ 2.0GHz, 80% AM Rated power frequency magnetic field a GB/T 17626.8 3A/m, 50/60Hz
AC power
Voltage sag d GB/T 17626.11 0% per cycle; 40% at 5/6 cycles; 70% at 25/30 cycles Voltage interruption d GB/T 17626.11 5%, duration. 250/300 cycles
Pulse group GB/T 17626.4 1kV (5/50ns, 5kHz)
Surge GB/T 17626.5 line-to-ground. 2kV/line-to-line. 1kV
RF conducted GB/T 17626.6 3V, 150kHz ~ 80MHz, 80% AM
DC power supply c
Pulse group GB/T 17626.4 1kV (5/50ns, 5kHz)
Surge GB/T 17626.5 line-to-ground. 2kV/line-to-ground. 1kV
RF conducted GB/T 17626.6 3V, 150kHz ~ 80MHz, 80% AM
I/O signal b
Pulse group GB/T 17626.4 0.5kV (5/50ns, 5kHz)
Surge GB/T 17626.5
RF conducted GB/T 17626.6 3V, 150kHz ~ 80MHz, 80% AM
Connected to mains
I/O signal
Pulse group GB/T 17626.4 1kV (5/50ns, 5kHz)
Surge GB/T 17626.5
RF conducted GB/T 17626.6 3V, 150kHz ~ 80MHz, 80% AM
a The test applies only to potentially magnetically sensitive equipment. CRT shows that the interference value is allowed to be greater than 1A/m. b Only applicable when the cable is longer than 3m.
c Not applicable for input ports that are intended to be connected to a battery or rechargeable battery that will be removed or disconnected from the device when recharging. With DC power output Equipment (using AC-DC power adapter) should be tested at the AC input port of the AC-DC power adapter specified by the manufacturer. Check. If not specified, a typical AC-DC power adapter should be used. This test is applicable to DC power input intended to permanently connect long distance lines port.
d "5/6 cycle" means "5 cycles at 50Hz test" and "6 cycles at 60Hz test". The performance criteria should be determined based on the test items, and comprehensive consideration should be given to the working mode of the test equipment that may affect the data results and the possible impact The working mode of the device under test which influences sample processing and user interface. The applicable immunity test items in Table 1 shall be applied to each of the equipment under test. Kinds of work modes.
After the test, the test results of the equipment under test may appear as performance criteria A, B, or C, but should not impair the residual risk to remain accessible Subject to the required performance characteristics within range. Guidance on the assessment of residual risk acceptability is given in ISO 14971. The test report shall include performance criteria.
6.3 Contingency
GB/T 18268.1-2010 6.3 applies to this section.
6.4 Performance criteria
GB/T 18268.1-2010 6.4 applies to this section.
7 Launch requirements
Chapter 7 of GB/T 18268.1-2010 is applicable to this part.
8 Test results and test reports
Chapter 8 of GB/T 18268.1-2010 is applicable to this part.
9 Instructions for use
The following replaces Chapter 9 of GB/T 18268.1-2010.
9.101 Requirements for the instructions for use of IVD equipment
The instructions for use included with the IVD equipment should include the following information. Note 1. It is the responsibility of the manufacturer to provide customers or users with EMC information for the equipment. Note 2. It is the user's responsibility to ensure the equipment's electromagnetic compatibility environment so that the equipment can work normally. 9.102 Instructions for use of IVD equipment for self-test
The instructions should include the following precautionary warnings related to electromagnetic compatibility, such as. a) "When using the device in a dry environment, especially in the presence of artificial materials (man-made fabrics, carpets, etc.), it is possible Will cause damaging electrostatic discharge, leading to wrong conclusions. " b) "Do not use this equipment near strong radiation sources, or it may interfere with the normal operation of the equipment." 9.103 Instructions for use of professional IVD equipment
The instructions should include the following.
a) Declare that the IVD equipment meets the emission and immunity requirements specified in this part of GB/T 18268. b) If the emission complies with Class A requirements, declare the following cautionary content. "This equipment is designed and tested in accordance with Class A equipment in GB 4824. In a domestic environment, this equipment may cause radio interference, which requires protective measures. " c) It is recommended to evaluate the electromagnetic environment before using the equipment. In addition, the instructions should include the following cautionary content related to electromagnetic compatibility. For example, "Prohibit Radio frequency sources), otherwise it may interfere with the normal operation of the equipment. " references
[1] AAMITIRNo.18..1997 GuidanceonElectromagneticCompatibilityofMedicalDevices forClinical/BiomedicalEngineers-Part 1. RadiatedRadio-FrequencyElectromagneticEnergy check Guide for electromagnetic compatibility of medical equipment for laboratory/biomedical technicians. Part 1. Radiated radio frequency electromagnetic energy [2] ANSIC63.18..1997 RecommendedPracticeforanOn-Site, AdHocTestMethodfor EstimatingRadiatedElectromagneticImmunityofMedicalDevicestoSpecificRadio-FrequencyTrans- mitters Recommendations for operating procedures for special field test methods for assessing the immunity of medical equipment to electromagnetic radiation from specific RF transmitters

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