YY/T 1057-2016Genral specifications for medical foot switch (English PDF)
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Issued by
According to the National Medical Products Administration's Medical Device
Level / Type
National · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2018
Scope
YY/T 1057-2016 (Genral specifications for medical foot switch) is available as an English-translated PDF.
YY/T 1057-2016 — 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 components for medical electrical equipment.
The scope of application of this Standard does not include pneumatic and hydraulic foot switches. NOTE. Foot switches that are not within the scope of application of this Standard can still refer to the relevant provisions of this Standard.
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Document preview — YY/T 1057-2016
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 30
Issued by: According to the National Medical Products Administration's Medical Device
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Terms and definitions4
- 4 Requirements4
- 5 Test methods6
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 components for medical electrical equipment. The scope of application of this Standard does not include pneumatic and hydraulic foot switches.
NOTE. Foot switches that are not within the scope of application of this Standard can still refer to the relevant provisions of this Standard.
2 Normative references
The following referenced 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 Degree 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 purpose of this document, the following terms and definitions apply.
make-contact element (normally open) A contact element that closes a circuit when the switch is activated.
break-contact element (normally closed) A contact element that breaks a circuit when the switch is activated.
4 Requirements
4.1 Performance requirements
4.1.1 Starting force
The starting force of the foot switch shall be no less than 10 N and no more than 50 N.
4.1.2 Working resistance
For a foot switch that uses a make-contact element (normally open)/break-contact element (normally closed), when the contact element is closed, the working resistance shall not be greater than 500 mohm.
4.1.3 Mechanical strength
4.1.3.1 The foot switch shall be able to withstand the weight of an adult in the normal position.
4.1.3.2 The foot switch shall not be significantly damaged after an accidental fall.
4.1.3.3 After completing the mechanical strength test, the foot switch shall still meet
the requirements of 4.1.1 and keep the expected function intact.
4.1.3.4 After completing the mechanical strength test, the control setting of the foot
switch shall not change when it is in an abnormal use position.
Example. When a foot switch that uses a make-contact element (normally open) is placed upside down relative to the normal use position, its contact element will not close.
4.1.4 Mechanical durability
4.1.4.1 The foot switch shall have sufficient mechanical durability.
4.1.4.2 After completing the mechanical durability test, the foot switch that uses a
make-contact element (normally open)/break-contact element (normally closed) shall still meet the requirements of 4.1.2.
4.1.4.3 After completing the mechanical durability test, the foot switch shall still meet
the requirements of 4.1.1 and keep the expected function intact.
4.1.4.4 After completing the mechanical durability test, the control setting of the foot
switch shall not change when it is in an abnormal use position.
4.1.5 Bending test of connecting wires
After the test specified in 5.1.5, the port connector of the foot switch connecting wire shall not be damaged and the expected function shall be intact.
4.1.6 Liquid ingress
After completing the tests of 5.1.3, 5.1.4 and 5.1.6, the foot switch shall be tested for water ingress as specified in Clause 14 of GB 4208-2008 according to the liquid ingress
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 6 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.12-1997 — Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
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YY/T 1057-2016
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