GB/T 14710-2009 (GB/T14710-2009, GBT 14710-2009, GBT14710-2009) & related versions
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Environmental requirement and test methods for medical electrical equipment
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The environmental requirements and test methods for medical electrical equipment
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GB/T 14710-2009: PDF in English (GBT 14710-2009)
GB/T 14710-2009
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
Foreword
This Standard replaces GB/T 14710-1993 "The Environmental Requirements and Test
Methods for Medical Electrical Equipment".
Compared with GB/T 14710-1993, major changes of this Standard are as follows.
— ADD requirements that the transportation test equipment can be used in the
transportation test;
— MODIFY requirements for the reference test conditions;
— MODIFY requirements for relevant special circumstances;
— MODIFY requirements and test methods for adaptability to power supply;
— ADD Annex A “Test requirements and inspection items”.
Annex A of this Standard is informative.
This Standard was proposed by the State Food and Drug Administration.
This Standard shall be under the jurisdiction of the National Technical Committee 10
on Medical Electrical Equipment of Standardization Administration of China (SAC/TC
10).
Responsible drafting organization of this Standard. Shanghai Testing & Inspection
Institute for Medical Devices.
Main drafters of this Standard. He Jun, and Shi Daifeng.
The previous edition of the standard replaced by this Standard is as follows.
— GB/T 14710-1993.
Environmental Requirement and Test Methods for Medical
Electrical Equipment
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.
JTG B01-2003 Technical Standard of Highway Engineering
3 Environment grouping
3.1 Equipment grouping according to climatic environment
Equipment is classified into three basic groups according to the service conditions.
a) Group I
In good environment. Generally, Group I equipment refers to those used in
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.
a) Rated operating low temperature test;
b) Low temperature storage test;
c) Rated operating high temperature test;
d) High temperature storage test;
e) Rated operating damp heat test;
test chamber (room) for monitoring test conditions;
— Temperature and humidity in the effective work space of test chamber (room)
shall remain the corresponding specified values in Table 1, with a temperature
difference no more than ± 2°C.
In order to keep required humidity, temperature fluctuation at control point shall
be kept within the range of ± 0.5°C.
Note. ± 2°C allowable temperature tolerance shall include measuring absolute error as well as
temperature uniformity and fluctuation in effective work space.
— Condensed water in test chamber (room) shall be discharged uninterruptedly.
Before purification treatment, the discharged condensed water shall not be used
as moisture source water;
— Water used for generating humidity shall have a resistivity not less than 500
Ω·m;
— The temperature in the effective work space inside the test chamber (room)
shall remain uniform and approach the values at the control points as much as
possible;
— Test equipment shall have such properties and electrical loads as generating no
obvious effects to the conditions in the test chamber (room);
— Water condensing on the side or top of test chamber (room) shall not drip on the
test sample;
— Test chamber (room) shall be equipped with observation window and lighting
device.
10.2 Requirements for the equipment
Requirements for the equipment are as follows.
— The equipment accessories shall be tested together with the equipment, unless
otherwise specified in the product standard;
— Equipment shall be put into the test chamber (room) at unpacking, ready-for-use
conditions and the normal operating position;
— If the work space of test chamber (room) is not large enough to carry out overall
test, if feasible to the equipment, partial machine may form a system with the
complete machine for separate test. Test methods shall be specified in the
product standard.
Note. this requirement is applicable to the equipment conducts rated operating low temperature
11.2.1 Preconditioning
PLACE the equipment under the reference test conditions to stabilize temperature.
11.2.2 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.
11.2.3 Test
PLACE the equipment in the test chamber (room). DISCONNECT the power supply.
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, and keep at the above
values for 4 h.
11.2.4 Recovery
At the end of the test, keep the equipment in the test chamber (room), and raise the
temperature of test chamber (room) to the reference test conditions. In order to
ensure no water condensing in the equipment, it shall reduce the temperature
recovery rate, or take other measures without prejudice to temperature test objective
to stabilize the equipment temperature. Recovery time shall be specified in the
product standard.
11.2.5 Final examination and measurement
After the equipment is recovered within specified time, switch on the power of the
equipment. After preheating, inspect the equipment according to the inspection items
specified in the product standard.
11.2.6 Details to be specified for quoting this Standard
Details to be specified for quoting this Standard are as follows.
a) Initial examination and measurement items and requirements;
b) Recovery time;
c) Final examin...
......
| Standard ID | GB/T 14710-2009 (GB/T14710-2009) | | Description (Translated English) | Environmental requirement and test methods for medical electrical equipment | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040 | | Word Count Estimation | 13,125 | | Date of Issue | 2009-11-15 | | Date of Implementation | 2010-05-01 | | Older Standard (superseded by this standard) | GB/T 14710-1993 | | Quoted Standard | JTG B01-2003 | | Drafting Organization | Shanghai Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Medical Electrical | | Regulation (derived from) | National Standard Approval Announcement 2009 No.13 (Total No.153) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | | Summary | This standard specifies the purpose of medical electrical equipment (hereinafter referred to as Equipment) environmental testing, environmental groups, transport test, ability to adapt to the power supply, benchmark test conditions, special circumstances, test procedures, test sequence, test requirements, test methods and references to the standards should be stipulated rules. This standard applies to all medical devices comply with the definition of electrical equipment or electrical system. |
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