YY/T 1099-2007 PDF in English
YY/T 1099-2007 (YY/T1099-2007, YYT 1099-2007, YYT1099-2007)
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Packaging, transportation and storage for medical X-ray equipment
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Standards related to (historical): YY/T 1099-2007
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YY/T 1099-2007: PDF in English (YYT 1099-2007) YY/T 1099-2007
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Replacing YY/T 91099-1999
Packaging, transportation and storage
for medical X-ray equipment
ISSUED ON. JANUARY 31, 2007
IMPLEMENTED ON. JANUARY 01, 2008
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Requirements ... 4
4 Test methods ... 7
5 Inspection rules ... 10
Packaging, transportation and storage
for medical X-ray equipment
1 Scope
This Standard specifies the requirements, test methods, inspection rules for
packaging, transportation and storage of medical X-ray equipment, accessories
and appliance (hereinafter referred to as the product).
This Standard is applicable to the packaging, transportation and storage of
medical X-ray equipment, accessories and appliance.
2 Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For dated references, the subsequent
amendments (excluding corrigendum) or revisions do not apply to this Standard,
however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
GB/T 191, Packaging and storage marks
GB/T 4768-1995, Mould-proof packaging
GB/T 4879-1999, Rustproof Packaging
GB/T 5048-1999, Moisture-proof packaging
GB/T 7350-1999, Packaging
GB 9706.1-1995, Medical electrical equipment -- Part 1. General
requirements for safety (idt IEC 60601-1.1988)
YY/T 0291-2007, Environmental requirements and test methods for medical
x-ray equipment
3 Requirements
3.1 Packaging
Product packaging shall meet scientific, economic, and firm requirements.
Packaging design shall be based on product characteristics, storage and
transportation, loading and unloading conditions and customer requirements.
Packaging shall be well protected, safe and reliable. The product has passed
the inspection, and the outer packaging can be carried out after protection and
other related inner packaging. Product packaging environment shall be clean,
dry, no harmful media.
3.1.1 Packaging marks
3.1.1.1 Packaging marks shall generally include.
a) the product name, model, specifications;
b) manufacturer’s name, register address, production address, contact
information;
c) number of medical device registration certificate;
d) the product standard number;
e) date of production or batch (sequence) number of the product;
f) box number, maximum size of the box (length × width × height);
g) gross weight and/or net weight;
h) products that are used for a limited period of time shall be marked with an
expiration date;
i) graphics, symbols, and other related content that shall be labeled based
on product characteristics;
j) environmental restrictions on transportation and storage.
3.1.1.2 When the product is packed in multiple boxes, the box number can be
expressed in fractions. The numerator is the box number, and the denominator
is the total number of boxes per product. The packaging of the main unit shall
be the No.1 box or other fairly clear representation. If necessary, the total
number of boxes of multiple products can be, in digits, preceded in front of the
fraction.
3.1.1.3 The selected packaging and transportation icon marks shall meet the
corresponding requirements of GB/T 191-2000.
3.1.2 Packaging method
3.1.2.1 Outer-packaging method
b) Moisture-proof packaging shall meet the requirements of GB/T 5048-1999;
c) Mildew-proof packaging shall meet the requirements of GB/T 4768-1995;
d) Anti-rust packaging shall meet the requirements of GB/T 4879-1999.
3.2 Transportation and storage
3.2.1 Transportation
The transportation shall comply with the following provisions.
a) The packaged product shall be able to adapt to the corresponding
transport tools of the transportation;
b) When transporting in open wagon, cover it with rainproof material;
c) The transportation conditions of products with special requirements shall
be separately specified.
3.2.2 Storage
The storage shall comply with the following provisions.
a) X-ray products cannot be stacked in the open air, and the products cannot
be stacked directly on the mud surface. If they are stacked in a short
period of time, they shall be protected from rain and snow. When products
are transferred at stations, docks, etc., they shall be stacked in the
warehouse. When they have to be stacked outdoors for a short period of
time, they shall be covered with rainproof and snow-proof materials, and
the bottom side shall be padded with wood;
b) Oil-sealed products can be properly stored during the anti-corrosion period
without being immersed in rainwater. Oil-sealed products that exceed the
anti-corrosion period and products that are not oil-coated shall be re-oiled
if long-term storage is required;
c) The storage conditions for special requirements shall be specified by the
manufacturer.
3.2.3 Environmental conditions for transportation and storage
It shall meet the requirements of 10.1 of GB 9706.1-1995.
4 Test methods
4.1 Packaging
4.1.1 Packaging marks
Carry out according to the methods specified in 6.1 of GB 9706.1-1995.
4.1.2 Packaging methods
4.1.2.1 Test of outer packaging method
a) When carrying out the lifting test, stacking test, and kilometer-
transportation test – it shall install the actual product in the packaging box
OR adopt the simulated piece that is similar to the product’s weight, center
of gravity and size.
-- lifting test.
Packages with a weight greater than or equal to 500kg shall be subject
to lifting test if hoisting is required. When lifting, the angle between the
sling and the horizontal plane of the box top is 45°~50°. When it rises
to a height above 1.5 m, use emergency-start and braking mode;
operate up, down, left and right for 3 min~5 min; then land smoothly to
the ground. Repeat the test for 3~5 times. After test, check and verify
according to the requirements of 3.1.2.1a).
-- stacking test.
Place the package (piece) on the surface of the compression tester or
on a flat concrete floor. Perform even and smooth loading. The loading
method can be to pressurize the compression test machine in a
packaging box (piece) OR stack the heavy objects directly on the top
of the box. The error of the total load applied when stacking heavy
objects directly on the top of the box does not exceed 2% of the
predetermined load value. The distance from the center of gravity of the
load plate is generally not more than 50% of the height of the package.
A flat-top packaging box with a load of 500 kg or more can be subject
to the following two tests. The load on the top of the box is evenly
loaded so that the top load is not less than 0. 49 N/cm2. The load plate
is placed on the top surface of the box, and the weight is loaded so that
the pile load is not less than 1.96 N/cm2. The load plate and loading
weight shall extend out of the box, and the protruding amount on each
side shall be no less than 100 mm. The load plate shall have sufficient
stiffness.
Packing box (piece) with a load of less than 500 kg can be loaded
evenly on the top surface of the box or on the load plate placed on the
top surface of the box. The length of each side of the top surface of the
box extending from the load plate is not less than 100 mm. The applied
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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