YY/T 1057-2016 PDF EnglishUS$130.00 · In stock · Download in 9 seconds
YY/T 1057-2016: Genral specifications for medical foot switch Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 1057: Historical versions
YY/T 1057-2016: Genral 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/YYT1057-2016YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.40 C 30 YY/T 1057-2016 Replacing YY 91057-1999 General specifications for medical foot switch According to the National Medical Products Administration’s Medical Device Industry Standard Announcement (No. 76 of 2022), this Standard will become a recommended standard from September 7, 2022 and will no longer be mandatory. Issued on: JANUARY 26, 2016 Implemented on: JANUARY 01, 2018 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Terms and definitions... 4 4 Requirements... 4 5 Test methods... 6 General specifications for medical foot switch1 ScopeThis 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 referencesThe 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 safety3 Terms and definitionsFor the purpose 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 activated. 3.2 break-contact element (normally closed) A contact element that breaks a circuit when the switch is activated.4 Requirements4.1 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 mΩ. 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 ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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