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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/YY1057-2016YY 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... 71 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 safety3 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 activated4 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.
