YY 91057-1999 English PDF (YY91057-1999)

This Standard is applicable to the foot switch which is used to control electronic circuit of a medical device product.

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
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 normal state, and not more than 1mA under single fault state.
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 times by foot. It shall meet the provisions of Article 2.5.
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. 3.3.6 Service life test
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
3.3.9.1 Voltage-withstanding test
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.
4.6 During acceptance, when both parties have dispute on whether the product quality is 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 provisions of Articles 2.2, 2.4, 2.6, 2.7, 2.8 and 2.11.
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;
b. Product name;
c. Rated voltage;
d. Rated current;
e. Identification number;
f. Date of production.