9秒发货/有发票 梧三标准英文版 优质技术翻译  数据库收录:159759 最近更新:2020-02-08  
支付宝/对公账号 首页   询价  购买流程  英文样品 公司简介   购物车

YY 91057-1999

标准搜索结果: 'YY 91057-1999'
标准号码内文价格(元)第2步交付天数标准名称状态
YY 91057-1999 英文版 275 购买 现货,9秒内自动发货PDF,有增值税发票。 医用脚踏开头通用技术条件 作废

   
标准详细信息 YY 91057-1999; YY91057-1999
中文名称: 医用脚踏开头通用技术条件
英文名称: General specifications for medical foot switch
行业: 医药行业标准
中标分类: C30
字数估计: 6,000
发布日期: 28/12/1987
实施日期: 1/3/1988
旧标准 (被替代): ZB C30014-1987
起草单位: Southwest instrumentarija
归口单位: Shanghai Institute of Medical Devices
范围: 本标准适用于脚踏开关, 该产品供医疗器械产品作控制电路用。


YY 91057-1999
YY
PROFESSIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
[Translator note. YY 91057 was renamed from ZB C 30014-87]
General Specifications for Medical Foot Switch
医用脚踏开关通用技术条件
ISSUED ON. DECEMBER 28, 1987
IMPLEMENTED ON. MARCH 01, 1988
Approved by. State Pharmaceutical Administration
Table of Contents
1 Type and basic parameters ... 3 
2 Technical requirements... 3 
3 Testing methods ... 5 
4 Inspection rules ... 7 
5 Mark, package, transportation and storage ... 8 
Additional information. ... 9 
Professional Standard of the People's Republic of China
YY 91057-1999 (ZB C 30014-87)
General specifications for medical foot switch
This Standard is applicable to the foot switch which is used to control electronic circuit of
a medical device product.
1 Type and basic parameters
1.1 The foot switch is divided into ordinary-type foot switch and sealed-type foot switch.
The foot switch used in an operating room shall be the sealed-type foot switch.
1.2 The operating voltage of the foot switch and the gap among contacts under the
“opening” state of the switch shall meet the provisions in Table 1.
Table 1
Voltage, V Gap, mm
≤ 50 ≥ 2
≤380 ≥ 3
≤ 500 ≥4
1.3.The structure, size and other parameters of the foot switch shall be regulated in
product standards or design documents.
2 Technical requirements
2.1 The foot switch shall meet the requirements of this Standard, and manufactured
according to drawings and documents approved by specified procedures.
2.2 The foot switch shall have good spray-proof, splash-proof and waterproof
performances, and pass through voltage-withstanding test after passing through the
following tests.
2.2.1 Ordinary-type. spray-proof and splash-proof tests.
2.2.2 Sealed-type. waterproof test.
2.3 If the high-frequency surgical equipment for operating room adopts two foot switches,
the “cutting” pedal must be on the left side and the “clotting” pedal must be on the right
side, viewed from the operator’s direction.
2.4 The starting force of the foot switch shall not be less than 10N (1.02kgf), and not more
than 50N (5.10kgf).
2.5 The foot switch shall be flexible, without locking and blocking phenomenon. The
contacts shall be able to be closed and opened well.
2.6 The foot switch shall be firm in structure.
2.6.1 The mechanical constituents of the foot switch must be able to withstand the force
of 1350N (138kgf) for 1 minute. There shall not have any over-bent, fractured, or that it
does not occur the force that exceeds the specified limit force at switching part.
2.6.2 After freely dropped for 3 times from the 1m-height position, The foot switch shall
still be operable; and there must not have any electrified component becoming
contactable; and it can pass the voltage-withstanding test.
2.7 The service life of the foot switch shall not be less than 25000 times.
2.8 The wire leading-out position of the foot switch shall be equipped with a clamping
device for preventing the wires from being pull-separated at the connection position, and
a protection sleeve for preventing the wires from being scratched. After the wires are
clamped by the clamping device, the wires shall be able to withstand the pulling force of
59N (6kgf). Use continuous force to pull for 1s every time; pull for 100 times; the
displacement shall not be more than 2mm.
2.9 The foot switch shall be stable when it is placed on the flat ground.
2.10 Electrical safety requirements for foot switch.
2.10.1 The switch shall meet the provisions of I-class B-type equipment in WS 2-295-83
General safety requirements for medical electrical equipment.
2.10.2 The voltage-withstanding test between the switch power supply part and the shell
shall meet the provisions of WS 2-295-83.
2.10.3 The earth leakage current of the switch shall not be more than 0.5mA under a
2.11 The climate and mechanical environment test of the foot switch shall meet the
provisions of WS 2-283-83 Environmental requirements and testing methods for medical
electrical equipment.
2.12 The painted parts on the shell of the foot switch shall meet the provisions of ZBC
30003.1-85 Classification and technical conditions for medical instrument paint coating.
Force is applied onto the stress point at where the foot switch is normally operated, so
that the switch can be steadily connected. It shall meet the provisions in Article 2.4.
3.3.4 Contact performance test
The contact performance is tested by simulating use-actions. The switch is treaded for 3
3.3.5.Mechanical structure fastness test
3.3.5.1 Strength test
The shell of the switch is applied with a pressure of 1350N (138kgf); last for 1min. It shall
meet the provisions of Article 2.6.1.
3.3.5.2 Drop test
The switch is freely dropped onto the 50mm-thickness hard wood block from the
1m-height position. The wood plate is horizontally placed on a hard substrate (concrete
block); every time, the switch is dropped from different positions, total 3 times. Then the
voltage-withstanding test is executed. It shall meet the provisions of Article 2.6.2.
The foot switch is in the loading state; the service life test is performed according to the
operation frequency of 30 times/min. It shall meet the provisions of Article 2.7.
3.3.7 Wire compression test
The wire compression test is executed according to the provisions of Article 3.2 in JB
846-66 Indoor lighting switch. It shall meet the provisions of Article 2.8.
3.3.8 Steadiness test
The foot switch is placed on the flat ground; tread by food; observe whether the switch is
stable. It shall meet the provisions of Article 2.9.
3.3.9 Test of electrical safety requirements
The voltage-withstanding test is executed according to the provisions of Article 3.6.5 in
WS 2-295-93. It shall meet the provisions of Article 2.10.2.
3.3.9.2 Earth leakage current test
The earth leakage current test is executed according to provisions of Articles 3.5.2.1 and
3.5.4.6 in WS 2-295-83. It shall meet the provisions of Article 2.10.3.
4.5 After reclassification-rectification, the products can be re-submitted for inspection.
During re-inspection, the double quantity of products shall be sampled and inspected
according to the provisions of Article 4.2. If it does not meet the provisions of Article 4.4,
this batch of products is deemed as not-acceptable.
qualified, it may be arbitrated by relevant organization.
4.7 Routine test shall be executed under the following conditions.
a. Before new product is launched into production (including transferring old
products);
b. Products, during continuous production, shall be regularly sampled-tested for not
less than once a year;
c. When re-launching the production after more than one year;
d. When design, process or material is changed significantly.
4.8.Except for all acceptance’s inspection items, routine test must also be subject to
5 Mark, package, transportation and storage
5.1 The foot switch which leaves the factory along with the matched complete-machine is
allowed without a nameplate, and the package requirements may be executed according
to the package requirements of the complete-machine.
5.2 The foot switch which individually leaves the factory shall be packed according to the
following provisions.
5.2.1 The switch shall be fixed with one nameplate at the obvious position; the following
marks shall be arranged on the nameplate.
a. Name or trademark of manufacturing factory;
c. Rated voltage;
d. Rated current;
e. Identification number;
f. Date of production.
   
宁德梧三商贸有限公司 | 纳税人识别号:91350900MA32WE2Q2X | 营业执照:营业执照证书
点击联络我们 联系电邮郑文锐销售经理: Sales@gb-gbt.cn | Sales@ChineseStandard.net | 电话郑经理: 18059327808 | 增值税普通发票 / 增值税专用发票样品
对公开户银行:中国建设银行古田支行 | 账户名称:宁德梧三商贸有限公司 | 账号:35050168730700000955 对公银行账号证书
翻译支持:全资母公司新加坡场测亚洲公司(https://www.ChineseStandard.net 卖欧美后再内销)
网站备案许可:闽ICP备19012676号
隐私   ·  优质产品   ·  退款政策   ·  公平交易   ·  关于我们