YY Translated English of Chinese Standard: YY PHARMACEUTICAL INDUSTRY STANDARD

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1 Translated English of Chinese Standard: YY Buy True-PDF Auto-delivery. PHARMACEUTICAL INDUSTRY STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS C 30 YY Replacing YY General specifications for medical foot switch 医用脚踏开关通用技术条件 Issued on: January 26, 2016 Implemented on: January 1, 2018 Issued by: China Food and Drug Administration of China Buy True-PDF Auto-delivery. Page 1 of 9

2 Table of Contents Foreword Scope Normative references Terms and definitions Requirements Test methods Buy True-PDF Auto-delivery. Page 2 of 9

3 Foreword This Standard was drafted in accordance with the rules given in GB/T This Standard replaces YY "General specifications for medical foot switch. The main technical changes are as follows: - modified the application scope of the standard; - modified the requirements for mechanical strength, fluid protection and connecting wires; - added "4.2 Safety requirements"; - deleted "2.1 Manufacture" of YY ; - deleted "2.9 Stationarity" of YY ; - deleted "2.10 Electrical safety" of YY ; - deleted "2.11 Mechanical and climatic environment test" of YY ; - deleted "2.12 Shell paint" of YY ; - deleted "2.13 Requirements for repair or replacement" of YY ; - deleted "4 Inspection rules" of YY ; - deleted "5 Requirements for marks, packaging, transport, storage" of YY Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by China Food and Drug Administration of China. This Standard shall be under the jurisdiction of Subcommittee on Medical Electronic Equipment of National Technical Committee on Medical Appliance of Standardization Administration of China (SAC/TC 10/SC 5). The drafting organizations of this Standard: Shanghai Medical Device Testing Institute. Main drafters of this Standard: He Jun, Hu Sheng. Version of standard substituted by this Standard is: Buy True-PDF Auto-delivery. Page 3 of 9

4 General specifications for medical foot switch 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 , Degrees of Protection Provided By Enclosure (IP Code) GB , 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 Buy True-PDF Auto-delivery. Page 5 of 9

5 possible abnormal positions. The control setting of the foot switch shall not be changed accidentally Mechanical durability 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. The foot switch shall be free from damage after the test and the function is expected to be intact The foot switch that uses make-contact element (normally open) / break-contact element (normally closed), after performing the test specified in , 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 After the test specified in is carried out, the starting force of the foot switch shall be measured according to the test method of 5.1.1, and the requirements of shall be met. Simulate the expected function of the foot switch to verify its integrity After the test specified in , 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 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 Liquid injection The foot switch shall be tested for water ingress as specified in Clause 14 of GB in accordance with the liquid inlet protection (IPX) class specified by the manufacturer. After the test, check if the foot switch still achieves the desired function. 5.2 Safety requirements The compliance with 4.2 requirements shall be checked by the test in GB and the relevant tests in the professional standards applicable to the Buy True-PDF Auto-delivery. Page 8 of 9