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YY 1057-2016General specifications for medical foot switches (English PDF)

医用脚踏开关通用技术条件

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Issued by

China Food and Drug Administration

Level / Type

Industry · Mandatory

Issue date

January 26, 2016

Implementation date

January 1, 2018

Scope

YY 1057-2016 is the English-translated version of 医用脚踏开关通用技术条件.

YY 1057-2016 is the Chinese pharmaceutical industry standard giving the general specifications for medical foot switches. It specifies terms and definitions, requirements and test methods for foot switches used as control circuit devices of medical electrical equipment; pneumatic and hydraulic foot switches are excluded, though they may refer to it.

Performance requirements cover the actuating force (not less than 10 N and not more than 50 N, applied over any 625 mm2 of the operating surface), the working resistance of make- and break-contact elements (measured by the Kelvin four-wire method), mechanical strength, mechanical durability (30 000 no-load operating cycles), a bending test of the connecting cable (3 kg load, 90 degree bends held for 1 min) and ingress of liquids to the IPX class declared by the manufacturer under GB 4208-2008; safety follows GB 9706.1 and the particular standards of the equipment concerned.

It replaces YY 91057-1999. Issued on 26 January 2016 by the China Food and Drug Administration, it has been in force since 1 January 2018. Classification: ICS 11.040.40, CCS C 30.

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Document preview — YY 1057-2016

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 30
Replacing: YY 91057-1999

Issued by: China Food and Drug Administration

Foreword3
1 Scope5
2 Normative references5
3 Terms and definitions5
4 Requirements5
5 Test methods7

1 Scope

This standard specifies the terms and definitions, requirements and test methods for medical foot switches.

This standard applies to foot switches used as control circuit devices of medical electrical equipment. Pneumatic and hydraulic foot switches are outside its scope.

Note: foot switches outside the scope of this standard may still refer to its relevant provisions.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB 4208-2008, Degrees of protection provided by enclosure (IP code)

GB 9706.1, Medical electrical equipment - Part 1: General requirements for safety

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1 make-contact element (normally open): a contact element that closes a circuit when the switch is actuated.

3.2 break-contact element (normally closed): a contact element that opens a circuit when the switch is actuated.

4.1 Performance requirements

4.1.1 Actuating force: the actuating force of the foot switch shall be not less than 10 N and not more than 50 N.

4.1.2 Working resistance: for foot switches with make-contact (normally open) or break-contact (normally closed) elements, the working resistance with the contact element closed shall not exceed the value specified in the standard.

4.1.4.1 The foot switch shall have sufficient mechanical durability.

4.1.4.2 After the mechanical durability test, foot switches with make-contact or break-contact elements shall still meet the requirements of 4.1.2.

4.1.5 Bending test of the connecting cable: after the test of 5.1.5, the cable entry of the foot switch shall not be damaged and the function shall be unimpaired.

4.2 Safety requirements

Medical foot switches shall comply with GB 9706.1 and with the relevant requirements of the particular standards applicable to the equipment with which they are used.

5.1 Performance tests

5.1.1 Actuating force: apply the test force, perpendicular to the operating surface, over any 625 mm2 area of the operating surface of the foot switch. Measure the minimum force at which the foot switch performs its intended control function. The result shall meet 4.1.1.

5.1.2 Working resistance: for foot switches with make-contact or break-contact elements, with the contact element closed, measure the working resistance at the far end of the foot switch cable by the Kelvin four-wire method. The result shall meet 4.1.2.

5.1.4.1 Operate the foot switch for 30 000 no-load operating cycles (no operating current); the movable part shall reach its maximum operating position in both directions.

5.1.4.4 After the test of 5.1.4.1, place the foot switch upside down and in every other possible abnormal position on the supporting surface. The control setting of the foot switch shall not change unintentionally.

5.1.5 Bending test of the connecting cable: with the axis of the cable entry vertical, hang a 3 kg mass on the cable 1 m from the entry. Tilt the foot switch so that the cable bends through 90 degrees and hold for 1 min; then tilt it the opposite way so that the cable bends through 90 degrees and hold for 1 min. After the test the cable shall meet 4.1.5.

5.1.6 Ingress of liquids: test the foot switch for ingress of water in accordance with Clause 14 of GB 4208-2008, to the IPX class specified by the manufacturer.

5.2 Safety tests

Compliance with 4.2 is checked by the tests of GB 9706.1 and the relevant tests of the particular standards applicable to the equipment with which the foot switch is used.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

GB 4208-2008

Cited by

Editions of YY 1057

Edition	Title	Revision	Status
YY 1057-2016	General specifications for medical foot switches	current edition	Current
YY 91057-1999	General specifications for medical foot switches	previous edition	Superseded

This page sells the current edition, YY 1057-2016. Earlier editions are listed for reference only.

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