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 El...