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YY 0900-2013: Walk training platform with suspension---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/YY0900-2013YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.60 C 42 Walk Training Platform with Suspension Issued on. OCTOBER 21, 2013 Implemented on. OCTOBER 1, 2014 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative References... 4 3 Terms and Definitions... 4 4 Classification... 5 5 Requirements... 5 6 Test Methods... 8 7 Inspection Rules... 11 8 Marking and Operation Instruction... 12 9 Packaging, Transportation and Storage... 14ForewordThis Standard was drafted in accordance with the rules in GB/T 1.1-2009. The safety requirements in this Standard comprehensively implement the content in GB 9706.1-2007 Medical Electrical Equipment - Part 1.General Requirements for Safety. In terms of all equipment or components whose materials or structural forms are different from what is stipulated in this Standard, if it can be proved that they reach an equivalent safety level, they shall be approved. Please be noted that certain content in this document might involve patents. The institution that issues this document shall not undertake any responsibility of identifying these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee 10 on Medical Electrical Equipment of Standardization Administration of China, Physical Therapy Equipment Subcommittee (SAC/TC 10/SC 4). The main drafting organizations of this Standard. China Food and Drug Administration, Tianjin Medical Devices Quality Supervision and Testing Center, Changzhou Qianjing Rehabilitation Co., Ltd. The main drafters of this Standard. Li Yanan, Yang Jiangang, Hu Zhiwei, Zhangyun, Wangying, Fan Jincheng, Xue Hufang. Walk Training Platform with Suspension1 ScopeThis Standard specifies the terms, definitions, classification, requirements, test methods, inspection rules, marking, operation instruction, packaging, transportation and storage of walk training platform with suspension (hereinafter referred to as equipment). This Standard is applicable to equipment stipulated in 3.1.2 Normative ReferencesThe following documents are indispensable to the application of this Standard. In terms of references with a specified date, only versions with a specified date are applicable to this Standard. The latest version (including all the modifications) of references without a specified date is also applicable to this Standard. GB/T 191 Packaging - Pictorial Marking for Handling of Goods GB 9706.1-2007 Medical Electrical Equipment - Part 1.General Requirements for Safety GB 9706.15 Medical Electrical Equipment - Part 1.General Requirements for Safety - 1.Collateral Standard. Safety Requirements for Medical Electrical Systems GB/T 14710 Environmental Requirement and Test Methods for Medical Electrical Equipment3 Terms and DefinitionsThose defined in GB 9706.1-2007 AND the following terms and definitions are applicable to this document. 3.1 Walk Training Platform with Suspension Walk training platform with suspension refers to medical electric-driven rehabilitation equipment, which is constituted of frame for suspension and walk training platform. 3.3 Walk Training Platform Walk training platform is an auxiliary device for patients’ walk training; it is generally electric-driven.4 ClassificationIn accordance with whether the frame for suspension is movable, the equipment can be classified into stationary and movable.5 Requirements5.1 Frame for Suspension 5.1.1 Lifting stroke Frame for suspension’s lifting stroke shall satisfy the requirements stipulated by the manufacturer; the deviation shall not be more than ± 5%. 5.1.5 Suspension belt 5.1.5.1 Adjustment and locking The suspension belt shall be equipped with adjustment and locking device, and easily operable. Locking shall be safe and reliable; easily recognizable and safely operated. It shall be manually operated without the help of any instruments. 5.2 Walk Training Platform 5.2.1 Timing setting The walk training platform shall have timing function; the timing error shall not be more than ± 1% of the set value, and not more than ± 1 min at the maximum. 5.2.3 Gradient setting In terms of walk training platform which has the function of gradient adjustment, gradient shall be continuously adjustable. It shall also have the function of adjustment indication; the deviation of gradient indication shall not exceed ± 10%. 5.2.4 Static load The walk training platform shall be able to maintain intact after supporting 6 times of the normal load stipulated by the manufacturer. 5.2.5 Safety of unexpected power outage As power supply recovers after unexpected power outage, the walk training platform would not automatically operate. 5.2.6 Emergency stop device Except from the power switch, the equipment shall also provide an emergency stop button, which can stop the training program at any time. This button shall take effect with just one action. This emergency stop button shall also be set up in a position accessible to patients during their training. 5.3 Overall Requirements of Equipment 5.3.1 Stability The whole equipment shall have smooth landing; the difference between the footing and the horizontal plane shall not be more than 2 mm. In addition, during usage, the equipment shall not waggle or generate any displacement; the angle of overturn shall not be less than 10°. After reliably positioning it, there shall be no displacement. 5.3.2 Operating noise During normal operation, the noise of the equipment shall not be more than 60 dB (A- weighted). 5.4 Operation Instruction The operation instruction shall satisfy the requirement in 6.8.2 in GB 9706.1-2007. Meanwhile, it shall also include the following content. 5.5 Safety Requirements The equipment shall satisfy the requirement in GB 9706.1-2007. If it is operated under medical electrical system, the equipment shall satisfy the requirement in GB 9706.15. 5.6 Environmental Test Requirements The equipment’s environmental test shall be conducted in accordance with the stipulation in GB/T 14710.6 Test Methods6.1 Frame for Suspension 6.1.1 Lifting stroke Respectively adjust the lifting stroke to the lowest end and the highest end. Measure its height; it shall comply with the requirement in 5.1.1. 6.1.5 Suspension belt 6.1.5.1 Adjustment and locking device Conduct the test in practical operation; it shall comply with the requirement in 5.1.5.1. 6.1.5.2 Width Conduct the test in practical measurement; it shall comply with the requirement in 5.1.5.2. 6.2 Walk Training Platform 6.2.1 Timing setting Select an appropriate timing, which shall not be less than 30 min; if the maximum set timing is less than 30 min, select the maximum set timing. Conduct the test in practical measurement; it shall comply with the requirement in 5.2.1. 6.2.3 Gradient setting Conduct the test in practical operation and measurement; it shall comply with the requirement in 5.2.3. 6.2.4 Static load Conduct the test in accordance with the requirement in 6.6 in GB 17498.6-2008; it shall comply with the requirement in 5.2.4. 6.2.5 Safety of unexpected power outage Conduct the test in practical operation; it shall comply with the requirement in 5.2.5. 6.2.6 Emergency stop device Conduct the test in visual inspection and practical operation; it shall comply with the requirement in 5.2.6. 6.2.7 Fatigue test In the test, simulate the equipment’s moving components in 100,000 times of no-load operation. After that, the equipment’s function shall still satisfy the requirement in 5.2.7. 6.3 Overall Requirements of Equipment 6.3.1 Stability Place the overall equipment on a flat surface; use a feeler gauge to measure the distance between the footing and the flat surface. 6.3.2 Operating noise Place the equipment on a hard table and at a distance of at least 3 m from the walls or other reflectors. Under the environment where background noise is 10 dB lower than the measuring point in the sound pressure level, operate the equipment under normal working state where the maximum noise might be generated; measure A-weighted sound level in the front, the back, the left, the right and the top of the host device of the equipment; they shall all satisfy the requirement in 5.3.2.If the manufacturer stipulates equipment’s special installation or arrangement conditions in the attached documents, the equipment can be arranged merely in accordance with the method stipulated by the manufacturer. 6.5 Safety Requirements Conduct the test through visual inspection and practical operation; it shall comply with the requirement in 5.5. 6.6 Environmental Test Requirements Conduct the test through visual inspection and practical operation; it shall comply with the requirement in 5.6. 6.7 Biocompatibility Consult relevant documents; it shall comply with the requirement in 5.7.7 Inspection Rules7.1 Inspection Classification Equipment’s quality inspection shall be classified into exit-factory inspection and type inspection. 7.2 Exit-factory inspection 7.3 Type Inspection 7.3.1 Type inspection shall be conducted under one of the following circumstances. 7.3.2 Determination of type inspection. if products are qualified in all the inspection items, then, they shall be determined as qualified in type inspection. Otherwise, they shall be determined as unqualified in type inspection.8 Marking and Operation Instruction8.1 Marking 8.1.1 Nameplate marking Nameplate shall be set up in an appropriate location on the equipment. Nameplate marking shall at least include the following content. 8.1.2 Marking on external packaging When equipment has external packaging, it shall at least include the following markings. 8.1.3 Marking on product inspection conformity certificate The marking on product inspection conformity certificate shall at least include the following content. 8.2 Operation Instruction Operation instruction shall at least include the following content.9 Packaging, Transportation and Storage9.1 Packaging 9.1.1 Equipment shall be individually packed. The external packaging shall be able to prevent product from natural damage; packaging materials shall comply with the stipulation in the ordering contract. 9.1.5 Equipment shall have the following attached documents. 9.2 Transportation Transportation requirements shall comply with the stipulation in the ordering contract. 9.3 Storage Equipment shall be stored at the temperature of -40 °C ~ 55 °C; relative humidity shall not exceed 90%. Equipment shall be stored in well-ventilated interior, where there is no corrosive gas. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
