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YY/T 0291-2007

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YY/T 0291-2007 英文版 345 购买 现货,9秒内自动发货PDF,有增值税发票。 医用X射线设备环境要求及试验方法 作废

   
标准详细信息 YY/T 0291-2007; YY/T0291-2007; YYT 0291-2007; YYT0291-2007
中文名称: 医用X射线设备环境要求及试验方法
英文名称: Environmental requirements and test methods for medical X-ray equipment
行业: 医药行业标准 (推荐)
中标分类: C43
国际标准分类: 11.040.50
字数估计: 10,000
发布日期: 2007-01-31
实施日期: 2008-01-01
旧标准 (被替代): YY/T 0291-1997
引用标准: GB 9706.1-1995; GB 9706.3-2000; GB/T 14710-1993
起草单位: 上海西门子医疗器械有限公司
归口单位: 全国医用X线设备及用具标准化分技术委员会
标准依据: 食品药品监督管理总局公告(2016年第74号)
提出机构: State Food and Drug Administration
发布机构: China Food and Drug Administration
范围: 本标准规定了医用X射线设备(以下简称设备)环境试验的目的、试验项目、环境分组、运输试验、对电源的适应能力、基准试验条件、特殊情况、试验程序、试验顺序、试验要求及试验方法等。本标准的目的是评定设备在各种工作环境和模拟贮存、运输环境下的适应性。

YY/T 0291-2007
Environmental requirements and test methods for medical X-ray equipment
ICS 11.040.50
C43
中华人民共和国医药行业标准
YY/T0291-2007
代替 YY/T 0291-1997
医用X射线设备环境要求及试验方法
2007-01-31发布
2008-01-01实施
国家食品药品监督管理局 发 布
目次
前言 Ⅰ
1 范围 1
2 规范性引用文件 1
3 环境分组 1
4 要求 2
5 试验方法 2
6 试验结果 5
附录A(规范性附录) 试验要求及检验项目 6
图1 Ⅰ组环境试验温度时间曲线 3
图2 Ⅱ组环境试验温度时间曲线 3
图3 Ⅰ组环境试验湿度时间曲线 4
图4 Ⅱ组环境试验湿度时间曲线 4
表1 环境试验条件分组 1
YY/T0291-2007
前言
本标准代替YY/T 0291-1997《医用X射线设备环境要求及试验方法》。
本标准与YY/T 0291-1997相比主要变化如下:
---按GB/T 1.1-2000的要求,对标准的条款作了重新编排;
---第1章和4.2按GB/T 14710-1993相关章的条文作了修改;
---4.1中增加了GB 9706.1和GB 9706.3的有关电源的章节的要求;
---5.3.3运输试验修改了“行车路面”、“行车距离”和“行车速度”的要求;
---高温贮存试验的要求按GB/T 14710-1993由70℃改为55℃;
---贮存恢复时间按GB/T 14710-1993改为不小于4h或由产品标准规定,并且相应更改了附
录A表A.1中的恢复时间;
---5.1中第一个破折号中的“该项试验”明确为“气候环境试验”,并删去了举例部分。第五个破
折号改为“如果产品标准对环境试验条件有特殊要求时,应按产品标准规定执行。”
---5.3.1.7中第一个破折号中初始检测、中间或最后检测的项目及要求,改为“由产品标准规
定”。
---按Ⅰ组和Ⅱ组不同的要求,将图1和图2分拆成4个图,并将图中相关试验的文字说明移到该
试验时序段的正上方,并删去了温度变化时的通电试验要求;
---附录A由资料性附录更改为规范性附录;
---附录A中表A.1中脚注c(1)增加了对初始检测的说明。
本标准的附录A为规范性附录。
本标准由国家食品药品监督管理局提出。
本标准由全国医用X线设备及用具标准化分技术委员会归口。
本标准起草单位:上海西门子医疗器械有限公司、辽宁省医疗器械产品质量监督检验所。
本标准主要起草人:梅伟铭、王寿民。
本标准所代替标准的历次版本发布情况为:YY/T 0291-1997。
YY/T0291-2007
医用X射线设备环境要求及试验方法
1 范围
本标准规定了医用X射线设备(以下简称设备)环境试验的目的、试验项目、环境分组、运输试验、
对电源的适应能力、基准试验条件、特殊情况、试验程序、试验顺序、试验要求及试验方法等。
本标准的目的是评定设备在各种工作环境和模拟贮存、运输环境下的适应性。
2 规范性引用文件
下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有
的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究
是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。
GB 9706.1-1995 医用电气设备 第一部分:安全通用要求(idt IEC 60601:1988)
GB 9706.3-2000 医用电气设备 第2部分:诊断X射线发生装置的高压发生器安全专用要求
(idt IEC 60601-2-7:1998)
GB/T 14710-1993 医用电气设备环境要求及试验方法
3 环境分组
3.1 设备按气候环境、机械环境分组
设备按气候环境、机械环境分组为Ⅰ组和Ⅱ组。见GB/T 14710-1993的2.1、2.2。
Ⅰ组:见GB/T 14710-1993的2.1.1,2.2.1。例如:医用X射线计算机体层摄影装置、大中型医
用X射线机、医用X射线影像增强器电视系统等固定安装X射线设备。
Ⅱ组:见GB/T 14710-1993的2.1.2,2.2.2。例如:移动式X射线机、可携带式X射线机等。
3.2 环境试验条件分组
环境试验条件分组见表1。
表1 环境试验条件分组
试 验 项 目 试 验 条 件
试 验 分 组
Ⅰ组 Ⅱ组
额定工作低温试验
低温贮存试验
额定工作高温试验
高温贮存试验
湿热贮存试验
温度/℃
温度/℃
相对湿度/(%)
温度/℃
相对湿度/(%)
10
-20
30 40
30 40
75+2-3
40±2
93±3
YY/T0291-2007

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
医用 X射线设备环境要求及试验方法
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
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
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
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
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
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.
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.
5.3.1 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
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
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
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.
   
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