YY 0900-2013 PDF English
US$150.00 · In stock · Download in 9 secondsYY 0900-2013: Walk training platform with suspension Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0900-2013 | English | 150 |
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Walk training platform with suspension
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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/YY0900-2013
YY
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 Contents
Foreword... 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... 14
Foreword
This 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 Suspension
1 Scope
This 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 References
The 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
Equipment
3 Terms and Definitions
Those 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 Classification
In accordance with whether the frame for suspension is movable, the equipment can
be classified into stationary and movable.
5 Requirements
5.1 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 Methods
6.1 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 Rules
7.1 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 Instruction
8.1 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 Storage
9.1 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.
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