YY/T 1099-2007 PDF EnglishUS$90.00 · In stock · Download in 9 seconds
YY/T 1099-2007: Packaging, transportation and storage for medical X-ray equipment Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 1099-2007: Packaging, transportation and storage for medical X-ray equipment---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/YYT1099-2007YY 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 ContentsForeword ... 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 equipment1 ScopeThis 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 referencesThe 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 equipment3 Requirements3.1 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 methods4.1 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 full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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