YY/T 0291-2016Environmental requirements and test methods for medical X-ray equipment (English PDF)
医用X射线设备环境要求及试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 0291-2016 is the English-translated version of 医用X射线设备环境要求及试验方法.
YY/T 0291-2016 is the Chinese pharmaceutical industry standard that sets the environmental requirements and the test methods for medical X-ray equipment: the groups of climatic and mechanical conditions such equipment must withstand in transport, storage and use, the tests for temperature, humidity, low pressure, vibration and shock, and the checks of function and appearance that follow each test. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 0291-2016
National Standard of the People's Republic of China
- Replacing
- YY/T 0291-2007
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope5
- 2 Normative References5
- 3 Terms and definitions5
- 4 Environment grouping6
- 5 Requirements6
- 6 Test methods8
- Annex A (Normative) Test requirements and test items12
- Annex B (Informative) Environment test sequence chart14
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.
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 Requirements
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;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 10149-1988Terminology and symbol for medical X-ray equipment
- GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment
GB 9706.3-2000 · GB 9706.18-2006 · GB 9706.24-2005
Cited by
- YY/T 1959-2025Particular specifications for digital intraoral X-ray imaging system
- YY/T 1307-2024Medical digital X-ray image detector used in mammography
- YY/T 0740-2022Particular specifications for medical X-ray angiography equipment
- YY/T 0795-2022Particular specification for dental cone-beam computed tomography equipment
- YY/T 0933-2022Digital medical X-ray image detector used in general radiography
- YY/T 0934-2022Dynamic digital medical X-ray image detectors
Similar standards
Editions of YY/T 0291
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0291-2016 | Environmental requirements and test methods for medical X-ray equipment | current edition | Current |
| YY/T 0291-2007 | Environmental requirements and test methods for medical X-ray equipment | previous edition | Superseded |
This page sells the current edition, YY/T 0291-2016. Earlier editions are listed for reference only.
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Related Standards
GB/T 10149-1988 — Terminology and symbol for medical X-ray equipment
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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