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[YY/T 1057-2016] General specifications for medical foot switch
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| YY/T 1057-2016 | English | 130 |
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General specifications for medical foot switch
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YY 1057-2016: General specifications for medical foot switch
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY1057-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
C 30
Replacing YY 91057-1999
General specifications for medical foot switch
Issued on. JANUARY 26, 2016
Implemented on. JANUARY 1, 2018
Issued by. China Food and Drug Administration of China
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Requirements... 5
5 Test methods... 7
1 Scope
This Standard specifies the terms and definitions, requirements and test
methods for medical foot switch.
This Standard is applicable to foot switch for medical electrical equipment as
control circuit device. 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 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, 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 of closing a circuit when the switch is activated
3.2 break-contact element (normally closed)
a contact element of disconnecting 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 10N and no more than 50N.
4.1.2 Working resistance
The working resistance of the foot switch that uses make-contact element
(normally open) / break-contact element (normally closed) shall not exceed
500m when contact element is in closed state.
4.1.3 Mechanical strength
4.1.4 Mechanical durability
4.1.4.1 Foot switch shall have sufficient mechanical durability.
4.1.4.2 The foot switch that uses make-contact element (normally open) /
break-contact element (normally closed), after completing mechanical durability
test, shall still meet the requirements of 4.1.2.
4.1.5 Wire bending test for connection
After the test specified in 5.1.5, the port connection of the foot switch connection
wire shall not be damaged, and the function is expected to be intact.
4.2 Safety requirements
The medical foot switch shall comply with the requirements of GB 9706.1; it
shall comply with the relevant requirements in the professional standards
applicable to the actual equipment of the foot switch.
5 Test methods
5.1 Performance requirements
5.1.1 Starting force
Apply the test force to any 625mm2 area on the operating surface of the foot
switch in a direction perpendicular to the plane of force. Measure the minimum
test force that enables the foot switch to achieve the desired control function.
The results shall meet 4.1.1 requirements.
5.1.2 Working resistance
For the foot switch that uses make-contact element (normally open) / break-
contact element (normally closed), when the contact element of the foot switch
is under closed state, it shall use the Kelvin four-wire method to measure the
working resistance of the foot switch at the far end of the foot switch cable. The
results shall meet 4.1.2 requirements.
5.1.3 Mechanical strength
5.1.4 Mechanical durability
5.1.4.1 Operate the foot switch to perform 30,000 no-load (no operating
current) operation cycle. The movable part of the foot switch shall reach the
maximum operating position in both directions.
5.1.4.2 The foot switch that uses make-contact element (normally open) /
break-contact element (normally closed), after performing the test specified in
5.1.4.1, when the contact element of the foot switch is under closed state, shall
use the Kelvin four-wire method to measure the working resistance of the foot
switch at the far end of the foot switch cable.
5.1.4.4 After the test specified in 5.1.4.1, the foot switch is turned over and
placed on the support surface in various possible abnormal positions. The
control setting of the foot switch shall not be accidentally changed.
5.1.5 Wire bending test for connection
First, let the axis at the connection wire port be in the vertical direction, and
hang an object with a mass of 3kg on the connecting wire 1m from the port.
Tilt the foot switch to bend the connecting wire by 90�� and keep it at this position
for 1min.
Subsequently, the foot switch is tilted in the opposite direction of the vertical
direction, so that the connecting wire is bent by 90��, and held at this position for
1min. After the test, the connecting wires shall meet the requirements of 4.1.5.
5.1.6 Liquid injection
The foot switch shall be tested for water ingress as specified in Clause 14 of
GB 4208-2008 in accordance with the liquid inlet protection (IPX) class
specified by the manufacturer.
5.2 Safety requirements
The compliance with 4.2 requirements shall be checked by the test in GB
9706.1 and the relevant tests in the professional standards applicable to the
actual equipment of the foot switch.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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