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Walk training platform with suspension
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YY 0900-2013: PDF in English YY 0900-2013
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 42
Walk Training Platform with Suspension
减重步行训练台
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
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
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1. Evaluation and
Testing within a Risk Management Process
GB 17498.6-2008 Stationary Training Equipment - Part 6. Treadmills - Additional
Specific Safety Requirements and Test Methods
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels,
Labeling and Information to be Supplied - Part 1. General Requirements
3 Terms and Definitions
Those defined in GB 9706.1-2007 AND the following terms and definitions are
applicable to this document.
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.
5.1.5.2 Width
The suspension belt shall be reasonably designed. The suspension belt that contacts
the buttock shall use soft materials; the edges shall be smooth; the width shall not be
less than 80 mm.
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.
5.2.2 Speed setting
The walk training platform shall have the function of speed control. Speed output shall
guarantee accuracy and uniformity. The deviation of accuracy shall not exceed ± 5%;
the deviation of uniformity shall not exceed 1 m/s. Speed shall be continuously
adjustable within the range stipulated by the manufacturer; the lowest speed shall not
exceed 0.5 km/h.
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
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.
In the equipment’s suspended device part, load the normal load stipulated by the
manufacturer. In accordance with the movement direction under normal training state,
or the direction which is the most unfavorable to stability, start to roll over from
horizontal. Use a protractor (precision. superior to 0.1°) to record the rolling-over angle.
The overall equipment shall be placed on a cement ground in accordance with the
requirement in the instruction. If there are trundles, lock the trundles. In the direction
of force, in the most unfavorable location at 1.5 m height of the equipment, impose 120
(1 ± 2%) N of horizontal pull or thrust; observe whether the equipment has moved.
The above test result shall comply with the requirement in 5.3.1.
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
Type Inspection All items
7.2.2 Determination of exit-factory inspection. if products are qualified in all the
inspection items, then, they shall be determined as qualified in exit-factory inspection.
Otherwise, they shall be determined as unqualified in exit-factory inspection.
7.3 Type Inspection
7.3.1 Type inspection shall be conducted under one of the following circumstances.
a) Before product registration (including old products which are switched to other
production);
b) When products have been continuously produced for a certain period (generally
not more than 2 years);
c) When production is resumed after over one year of suspension;
d) When there are significant changes in product structure, materials, process or
key components;
e) When there are relatively large differences between the result of exit-factory
inspection and design requirements;
f) When national quality supervision and inspection institution requests.
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.
a) Manufacturer’s name or trademark;
b) Product’s name, specification and model;
c) Power voltage, frequency and input power;
d) Date and serial number of production;
e) Registered product’s standard number and product registration number.
8.1.2 Marking on external packaging
When equipment has external packaging, it shall at least include the following
markings.
a) Manufacturer’s name and address;
b) Product’s name, specification and model;
c) Date and serial number of production;
d) Registered product’s standard number and product registration number;
e) Volume (length x width x height);
f) Net weight and gross weight;
g) Written words or markings like “fragile”, “this side up” “keep away from rain”;
markings shall comply with relevant stipulation in GB/T 191.
It shall be guaranteed that written words or markings on the box would not become
ambiguous after a long time.
8.1.3 Marking on product inspection conformity certificate
The marking on product inspection conformity certificate shall at least include the
following content.
a) Manufacturer’s name;
b) Product’s name, specification and model;
c) Marking of inspection conformity and inspector’s code number;
d) Date of inspection.
8.1.4 Label, marking and symbols in provided information
They shall comply with the requirement in YY/T 0466.1.
8.2 Operation Instruction
Operation instruction shall at least include the following content.
a) Manufacturer’s name, trademark and address;
b) Product’s name, specification and model;
c) Product’s characteristics, purposes, scope of application, main performance
and technical parameters;
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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