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YY/T 1796-2021 English PDF

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YY/T 1796-2021: (Special technical conditions for medical dry film)
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Basic data

Standard ID YY/T 1796-2021 (YY/T1796-2021)
Description (Translated English) (Special technical conditions for medical dry film)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Word Count Estimation 7,740
Issuing agency(ies) State Drug Administration

YY/T 1796-2021: (Special technical conditions for medical dry film)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Special technical conditions for medical dry film) ICS 11.040.50 C43 People's Republic of China Pharmaceutical Industry Standard Special technical conditions for medical dry film Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration

foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. Publication of this document Institutions do not assume responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC10/SC1) focal point. This standard was drafted by. Liaoning Provincial Medical Device Inspection and Testing Institute, Taizhou Ruikehua Medical Technology Co., Ltd., Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., Lucky Medical Technology Co., Ltd., Fujifilm (China) Investment Co., Ltd., Agfa Medical System Equipment (Shanghai) Ltd. The main drafters of this standard. Wang Yanan, Lu Yang, Chen Xia, Wang Hongze, Tang Zhiwei, Chen Bin. Special technical conditions for medical dry film

1 Scope

This standard specifies the requirements and test methods for medical dry film (hereinafter referred to as film). This standard applies to medical imaging (X-ray computed tomography equipment, medical imaging magnetic resonance equipment, X-ray Medical dry film recorded by image plate imaging device for radiography, digital photographic X-ray machine, etc.), including. made of polyester (PET) film base Medical dry laser film, medical infrared laser film composed of silver salt and protective layer, and polyester (PET) film base, heat-sensitive layer, protective layer Composition of thermal film.

2 requirements

2.1 Film size The film shall meet the requirements of this technical condition and be manufactured in accordance with the drawings and technical documents approved by the prescribed procedures. Regular size [cm (in)]. 20×25 (8×10), 25×30 (10×12), 26×36, 28×35 (11×14), 35×43 (14×17). The manufacturer shall specify the According to the cutting size of the specification size, the cutting tolerance should meet the requirements of Table 1. Table 1 Conventional Film Sizes Specification size/cm(in) Cutting tolerance/mm 20×25(8×10) 25×30(10×12) ±0.8 26×36 28×35(11×14) 35×43(14×17) ±1.0 Note. Films of other specifications can be cut according to user requirements. 2.2 Film shape 2.2.1 The shape of the film is a rectangle with rounded corners. The rounded corners should be smooth, there should be no burrs and edges and corners, and there should be no tangents between the arc and the straight edge. ladder. 2.2.2 The size requirements for the fillet of the film are shown in Figure 1.The arc of each rounded corner of the film should be within the shaded range shown in Figure 1.

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