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YY/T 0291-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Replacing YY/T 0291-2007
Environmental requirements and test
methods for medical X-ray equipment
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and definitions ... 5
4 Environment grouping ... 6
5 Requirements ... 6
6 Test methods ... 8
Annex A (Normative) Test requirements and test items ... 12
Annex B (Informative) Environment test sequence chart ... 14
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Compared with YY/T 0291-2007, the major technical changes of this Standard are as
follows.
-- it adds in the normative references JTG B01-2014, Technical Standard of
Highway Engineering;
-- it adds the clause of terms and definitions;
-- it modifies the expression of environment grouping (see 4; and see 3 of 2007
edition);
-- it modifies the expression of requirements (see 5; and see 4.1, 4.2 and 4.3 of
2007 edition);
-- it modifies the expression of special circumstances (see 6.3; and see 5.1 of edition
2007);
-- it modifies the expression of test sequence (see 6.1.2; and see 5.2.2 of 2007
edition);
-- it modifies the expression of test content (see 6.2; and see 5.2.3 of edition 2007);
-- it modifies the expression of environment test methods (see 6.2; and see 5.3 of
2007 edition);
-- it modifies the expression of requirements for recovery time and requirements for
power supply adaptability (see Table A.1; and see Table A.1 of 2007 edition);
-- it adds the environment test sequence chart Annex B as an informative annex.
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuer of this document shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of Subcommittee 1 on Medical X-ray
Equipment and Tools of National Technical Committee 10 of Standardization
Administration of China (SAC/TC 10/SC 1).
The drafting organizations of this Standard. Liaoning Medical Device Test Institute,
Shanghai Siemens Medical Device Co., Ltd.
The main drafters of this Standard. Jin Yubo, Zhao Jin, Liu Congzhi, Mei Weiming.
Environmental requirements and test
methods for medical X-ray equipment
1 Scope
This Standard specifies the environment grouping, requirements and test methods for
medical X-ray equipment (hereinafter referred to as equipment).
This Standard applies to medical X-ray equipment.
2 Normative References
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to This Standard.
GB 9706.1-2007, Medical electrical equipment – Part 1. General requirements for
safety
GB 9706.3-2000, Medical electrical equipment – Part 2. Particular requirements for
the safety of high-voltage generators of diagnostic X-ray generators
GB 9706.18-2006, Medical electrical equipment - Part 2. Particular requirements for
the safety of X-ray equipment for computed tomography
GB 9706.24-2005, Medical electrical equipment - Part 2-45. Particular requirements
for the safety of mammographic X-ray equipment and mammographic sterotactic
devices
GB/T 10149-1988, Terminology and symbol for medical X-ray equipment
GB/T 14710-2009, Environmental requirement and test methods for medical
electrical equipment
JTG B01-2014, Technical Standard of Highway Engineering
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB/T 10149-
1988 apply.
After test, the fasteners of equipment shall not become loose, which shall be tested in
accordance with the test items specified in product standard.
5.2.4 Power supply adaptability
5.2.4.1 The power supply of equipment is set at 110% and 90% of rated working
voltage, supply frequency 50 Hz ± 1 Hz (if necessary). Maintain the voltages for at
least 15 min and then test the relevant test items specified in product standard.
5.2.4.2 For equipment having special requirements for power supply frequency and
voltage, its working range of frequency and voltage can be specified otherwise in
product standard.
6 Test methods
6.1 Test procedure and test sequence
6.1.1 Test procedure
Each test normally includes the following procedures.
a) pretreatment (if necessary);
b) initial detection (if necessary);
c) test;
d) intermediate detection (if necessary);
e) recovery (if necessary);
f) final detection.
6.1.2 Test sequence
When multiple tests are conducted for the same equipment, tests shall be normally
conducted in the following sequence.
a) rated working low temperature test;
b) low temperature storage test;
c) rated working high temperature test;
d) high temperature storage test;
e) rated working damp heat test;
f) damp heat storage test;
Under the condition of normal package of equipment, equipment shall be fixed to the
rear part of truck in accordance with the sign “UP” location. The load of truck during
test is 1/3 of the rated load.
Test can be conducted using truck or transportation test apparatus.
After test, test whether equipment fasteners become loose and conduct test items in
accordance with product standard.
6.2.4 Power supply adaptability test
This test is normally conducted during rated working low temperature test and rated
working high temperature test. During test, connect the power cord of equipment to an
adjustable power supply; maintain the output frequency of the adjustable power supply
at the rated product frequency; set voltages at 110% and 90% of rated product voltage;
maintain the voltages at least 15 min; and then conduct relevant test items specified
in product standard.
6.3 Special circumstances
Consider the following circumstances.
a) climatic environment test only applies to those parts or components which may
be subjected to the climatic conditions simulated by test;
b) equipment shall be placed in test chamber unpackaged, in the ready-for-use
state, at a normal working position;
c) equipment accessories shall be tested along with equipment, unless they are
specified otherwise in product standard;
d) the components which can be detached without using tools shall be detached
and tested along with major parts;
e) if test can’t be conducted without disassembling and reassembling, the time
intervals between treatment and test and between test and detection shall be
decided in accordance with the time of equipment handling, assembling and
debugging;
f) if equipment (such as large equipment or equipment having special
requirements for service environment) is inappropriate for some environment
test items (such as rated working low temperature test, rated working high
temperature test, rated working damp heat test and so on), the manufacturer
shall provide specific test requirements and indicate in product standard;
g) if product standard has special requirements for environment test conditions,
they shall be implemented as specified in product standard. When it is
impossible to test the whole machine, product standard shall specify which key
parts or components are to be tested;
......
YY/T 0291-2007
YY
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Replacing YY/T 0291-1997
Environmental requirements and test methods for
medical X-ray equipment
ISSUED ON. JANUARY 31, 2007
IMPLEMENTED ON. JANUARY 1, 2008
Issued by. China State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Environmental groups ... 5
4 Requirements ... 6
5 Test methods ... 7
6 Test results ... 11
Annex A ... 12
Foreword
This Standard replaces YY/T 0291-1997 Environmental requirements and test
methods for medical x-ray equipment.
Compared with YY/T 0291-1997, the main changes are as follows.
- rearranged clauses of Standard, according to requirements of GB/T 1.1-
2000;
- modified certain clauses of GB/T 14710-1993 in Clause 1 and 4.2 of this
Standard;
- added requirements for power supply in GB 9706.1 and GB 9706.3;
- modified requirements for “driving road”, “driving distance” and “driving
speed”;
- modified requirements for high temperature storage test from 70°C to
55°C, according to GB/T 14710-1993;
- modified storage recovery time to not less than 4 h or determined by
product standard, according to GB/T 14710-1993; modified recovery time
in Table A.1 in Annex A;
- specified “this test” as “climatic environment test” in the 1st dash in 5.1;
deleted examples; modified the 5th dash to “it shall perform according to
provisions of product standard, if product standard has special
requirements for environment test conditions”;
- modified the initial detection, middle or final detection items and
requirements in the 1st dash in 5.3.1.7 to “specified by product standard”;
- split Figure 1 and Figure 2 into 4 figures, according to different
requirements of Group I and Group II; moved text description of relevant
test in figure to right above the test sequence segment; deleted electrifying
test requirements when temperature changes;
- changed Annex A from informative to normative;
- added instructions on initial detection in Footnote c(1) in Table A.1 of
Annex A.
Annex A of this Standard is normative.
This Standard was proposed by China State Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee
Environmental requirements and test methods for
medical X-ray equipment
1 Scope
This Standard specifies the purpose of environment test, test items,
environment group, transport test, adaptability to power supply, standard test
conditions, special situations, test procedures, test sequence, test requirements
and test methods of medical X-ray equipment.
This Standard is to evaluate the adaptability of equipment under various
working environments and stimulation of storage and transport environment.
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references,
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 9706.1-1995 Medical electrical equipment - Part 1. General
requirements for safety (idt IEC 60601.1998)
GB/T 9706.3-2000 Medical electrical equipment Part 2. Particular
requirements for the safety of high-voltage generators of diagnostic X-ray
generators (idt IEC 60601-2-7.1998)
GB/T 14710-1993 Environmental requirement and test methods for
medical electrical equipment
3 Environmental groups
3.1 Classify the equipment according to climatic environment and
mechanical environment
Classify the equipment into Group I and Group II according to climatic
environment and mechanical environment, as shown in 2.1, 2.2 of GB/T 14710-
During the test, power supply network shall meet requirements of 10.2.2 in GB
9706.1-1995 and 10.2.2a) in GB 9706.3-2000.
4.2 Adaptability to power supply
For equipment of network power supply, the power supply frequency is 50 Hz
± 1 Hz (if necessary); voltage is 220 V ± 22 ± or 380 V ± 38 V.
For equipment which has special requirements for power supply frequency and
power supply voltage, the working range of its frequency and voltage is
specified in product standard.
4.3 Test requirements
4.3.1 Climatic environment test requirements
See climatic environment group requirements in Table 1.
4.3.2 Mechanical environment test requirements
See mechanical environment group requirements in Table 1.
4.3.3 Transport test requirements
The equipment shall be tied in the back of heavy-duty truck for transport test
according to normal exit-factory packaging conditions.
After the test, carry out the detection to the equipment according to detection
items specified in product standard.
5 Test methods
5.1 Special situations
The test shall consider the following special situations.
- climatic environment test is only applicable to those parts or components
which might be affected by the stimulated climatic conditions;
- when test for the whole equipment is not feasible, it shall specify in
product standard that which key parts or components are available to the
test;
- if decomposition or re-assembly is essential to the test, the interval
between treatment and test, or the interval between test and inspection
shall be determined according to equipment transport, assembly and
adjustment time;
- the components which can be opened without tools must be opened and
tested together with main components;
- it shall specify in product standard if product standard has special
requirements for environment test conditions.
5.2 Test specification
5.2.1 Test procedure
Every test usually contains the following programs.
a) pre-treatment (when necessary);
b) initial inspection (when necessary);
c) test;
d) middle inspection (when necessary);
e) recovery (when necessary);
f) final inspection.
5.2.2 Test sequence
It shall perform according to the provisions in Clause 8 of GB/T 14710-1993.
5.2.3 Test requirements
It shall perform according to the provisions in Clause 9 of GB/T 14710-1993.
5.3 Environment test methods
5.3.1 Climatic environment test method
See temperature test timing diagrams (Figure 1, Figure 2) and humidity test
timing diagrams (Figure 3, Figure 4).
- Recovery time. the recovery time of storage test shall not be less than 4
h or specified by product standard.
- Thermal equilibrium. it shall make the equipment or parts reach to thermal
equilibrium during inspection. The thermal equilibrium shall not be less
than 1 h.
5.3.2 Mechanical environment test methods
5.3.2.1 Vibration test
It shall perform according to the provisions of 10.7 in GB/T 4710-1993. The
parts for test shall at least include the controller, the high voltage transformer
assembly (excluding a component with an X-ray tube).
5.3.2.2 Impact test
It shall perform according to the provisions of 10.8 in GB/T 14710-1993. The
parts for test shall at least include the controller, the high voltage transformer
assembly (excluding a component with an X-ray tube). The test direction shall
simulate the part easy to touch at normal working position.
5.3.2.3 Transport test
Under normal exit-factory packaging conditions, the equipment shall be tied in
the back of heavy-duty truck according to “upward” sign. The load of truck
during the test shall be about 1/3 of rated load.
Driving road. secondary road;
Driving distance. 600 km;
Driving speed. 60 km/h ~ 80 km/h.
After the test, detect the equipment according to the inspection items specified
by the product standard.
6 Test results
After the aforementioned test procedure is completed, in addition to the
functional examination according to 5.3.1.7, it shall also carry out visual
inspection on the equipment or parts. There shall be no corrosion, cracks,
peeling or other damages to the coating layer. The texts and marks should be
clear. Control mechanism should be flexible. There should be no tightening
parts or overflowing perfusion.
Annex A
(Normative)
Test requirements and inspection item
Test requirements and inspection items are listed in the Annex for the
modification of the product standard.
......
| Standard ID | YY/T 0291-2016 (YY/T0291-2016) | | Description (Translated English) | Environmental requirements and test methods for medical X-ray equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 10,173 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | YY/T 0291-2007 | | Drafting Organization | Liaoning Province, medical equipment testing, Shanghai Siemens Medical Devices Co., Ltd. | | Administrative Organization | (SAC/TC 10/SC 1) National Standard Committee on Medical Electrical Appliances Standardization Technical Committee for Medical X-ray Equipment and Appliances Standardization Subcommittee (SAC/TC 10/SC 1) | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Proposing organization | State Administration of Food and Drug Administration | | Issuing agency(ies) | State Administration of Food and Drug Administration | | Standard ID | YY/T 0291-2007 (YY/T0291-2007) | | Description (Translated English) | Environmental requirements and test methods for medical X-ray equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 10,171 | | Date of Issue | 2007-01-31 | | Date of Implementation | 2008-01-01 | | Older Standard (superseded by this standard) | YY/T 0291-1997 | | Quoted Standard | GB 9706.1-1995; GB 9706.3-2000; GB/T 14710-1993 | | Drafting Organization | Siemens Shanghai Medical Equipment Co., Ltd. | | Administrative Organization | National Standardization Technical Committee of medical X-ray equipment and utensils | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the medical X-ray equipment (hereinafter referred to as the device) Environmental testing purposes, pilot projects, environmental groups, transportation test, ability to adapt to the power, the benchmark test conditions, special cases, test procedures, test sequence, the test requirements and test methods. This standard applies to assess the work environment in a variety of devices and analog storage, transport environment adaptability. | | Standard ID | YY/T 0291-1997 (YY/T0291-1997) | | Description (Translated English) | Environmental requirements and test methods for medical X-ray equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 8,840 | | Date of Issue | 1997/7/30 | | Date of Implementation | 1997/10/1 |
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