GB/T 14710-2009 PDF English
US$85.00 · In stock · Download in 9 secondsGB/T 14710-2009: Environmental requirement and test methods for medical electrical equipment Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB/T 14710: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 14710-2009 | English | 85 |
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Environmental requirement and test methods for medical electrical equipment
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| GB/T 14710-1993 | English | 399 |
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The environmental requirements and test methods for medical electrical equipment
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GB/T 14710-2009: Environmental requirement and test methods for medical electrical equipment---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT14710-2009
GB
ICS 11.040
C 30
National Standard
of the People’s Republic of China
Replacing GB/T 14710-1993
Environmental Requirement and Test Methods for
Medical Electrical Equipment
Issued on. NOVEMBER 15, 2009
Implemented on. MAY 1, 2010
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.
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Environment grouping... 4
4 Transportation test... 6
5 Adaptability to power supply... 6
6 Reference test conditions... 7
7 Special circumstances... 7
8 Test procedures... 8
9 Test sequence... 8
10 Test requirements... 9
11 Test Methods... 11
Annex A... 19
1 Scope
This Standard specifies the medical electrical equipment’s (hereinafter referred to as
equipment) environment test purposes, environment grouping, transportation test,
adaptability to power supply, reference test conditions, special circumstances, test
procedures, test sequence, test requirements, test methods, and detailed-rules that
need to be specified when quoting this Standard.
This Standard is applicable to all electrical equipment or electrical systems in
conformity with the definitions of medical equipment.
Note. E.g. that medical electrical equipment as defined in GB 9706.1, the electrical equipment for
laboratory as specified in GB 4793.1, and medical electrical system as defined in GB 9706.15.
This Standard aims at evaluating the adaptability of equipment to various service
environment, and simulated storage and transportation environment.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Standard, however, parties
who reach an agreement based on this Standard are encouraged to study if the latest
versions of these documents are applicable. For undated references, the latest edition
of the referenced document applies.
3 Environment grouping
3.1 Equipment grouping according to climatic environment
Equipment is classified into three basic groups according to the service conditions.
3.2 Equipment grouping according to mechanical environment
Equipment is classified into three basic groups according to the transportation and
circulation conditions.
3.3 Environment test condition grouping
Environment test condition grouping is detailed in Table 1.
4 Transportation test
Under normal exit-factory packaging conditions, the equipment shall be bundled at
the back of motor truck according to the mark "This Side UP". In the test, load
capacity of the truck shall be 1/3 of the rated load capacity.
5 Adaptability to power supply
5.1 For the equipment that is powered by grid power source, its test voltage is 110% or 90% of the rated value.
5.2 For the equipment that has special requirements to the power supply frequency
and the power supply voltage, the operating frequency, voltage working-range, and
test methods may be otherwise stated in the product standard.
6 Reference test conditions
Reference value or range and allowable tolerance under reference test conditions are
detailed in Table 2.
7 Special circumstances
7.1 If the test condition of test group specified by the manufacturer are not quite
consistent with those specified in Table 1, then it shall be conducted according to
those specified by the manufacturer.
7.2 If individual influence quantity fails to be tested according to the reference test
conditions specified in this Standard, then it shall conduct the test according to the
conditions specified by the manufacturer.
7.3 When the overall test is infeasible, the equipment may be tested partially (dozens
of parts), and the manufacturer shall specify which critical component or part is to be
tested.
7.4 When some environment test items (e.g. rated operating low temperature test,
rated operating high temperature test, rated operating damp heat test) are not
applicable to the equipment, the specific test requirements shall be provided by the
manufacturer and stated in the product standard.
7.5 When other national or professional standards are applicable to the equipment
and state the requirements of environment tests, environment tests shall be carried
out according to the requirements of these standards.
8 Test procedures
Generally, each test includes the following procedures.
a) Preconditioning (if necessary);
b) Initial examination and measurement (if necessary);
c) Test;
d) Intermediate examination and measurement (if necessary);
e) Operation test (if necessary);
f) Recovery (if necessary);
g) Final examination and measurement.
9 Test sequence
When carrying out multiple tests for the same equipment successively, the test is
generally carried out in the sequence as follows.
10 Test requirements
10.1 Requirements for the test chamber (room)
10.1.1 Requirements for the test chamber (room) for temperature test
Requirements for the test chamber (room) for temperature test are as follows.
10.1.2 Requirements for the test chamber (room) for damp heat test
Requirements for the test chamber (room) for damp heat test are as follows.
10.2 Requirements for the equipment
Requirements for the equipment are as follows.
11 Test Methods
11.1 Rated operating low temperature test
11.1.1 Preconditioning
PLACE the equipment under the reference test conditions to stabilize temperature.
11.1.2 Initial examination and measurement
After the equipment is at stable temperature, switch on the power of the equipment.
After preheating, inspect the equipment according to the inspection items specified in
the product standard.
11.1.3 Test
PLACE the equipment in the test chamber (room). REDUCE the temperature in the
test chamber (room) to the corresponding values specified in Table 1 at an average
speed of 0.3°C/min~1°C/min. SWITCH on or load according to the requirements of the
product standard. Test duration only needs to maintain the equipment to reach stable
temperature, but shall not be lower than 1 h.
11.1.4 Final examination and measurement
After test duration, immediately inspect the equipment at that temperature according
to the inspection items specified in the product standard.
11.1.5 Details to be specified for quoting this Standard
Details to be specified for quoting this Standard are as follows.
11.2 Low temperature storage test
11.3 Rated operating high temperature test
11.3.1 Preconditioning
PLACE the equipment under the reference test conditions to stabilize temperature.
11.3.2 Initial examination and measurement
After the equipment is at stable temperature, switch on the power of the equipment.
After preheating, inspect the equipment according to the inspection items specified in
the product standard.
11.3.3 Test
PLACE the equipment in the test chamber (room). RAISE the temperature in the test
chamber (room) to the corresponding values specified in Table 1 at an average speed
of 0.3°C/min~1°C/min. SWITCH on or load according to the requirements of the
product standard. Test duration only needs to maintain the equipment to reach stable
temperature, but shall not be lower than 1 h.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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