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YY/T 1796-2021Particular specifications for medical dry film (English PDF)

医用干式胶片专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

September 1, 2022

Scope

YY/T 1796-2021 is the English-translated version of 医用干式胶片专用技术条件.

YY/T 1796-2021 is the Chinese pharmaceutical industry standard for medical dry film, the film on which images from CT, magnetic resonance, computed radiography and digital radiography are printed without wet processing.

It sets the requirements and the test methods, covering the density range and the characteristic curve, the image resolution and uniformity, the dimensional stability, the adhesion of the layers and the durability of the image in storage and under light.

It covers both silver-salt dry laser film on a polyester base and thermosensitive film made of a polyester base with a heat-sensitive layer and a protective layer. Issued on 6 September 2021, it has applied since 1 September 2022.

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Document preview — YY/T 1796-2021

National Standard of the People's Republic of China

Classification: C 43

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Requirements

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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.

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

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