BS EN ISO 3665:2013 pdf free
BS EN ISO 3665:2013 pdf free.Photography一Intra-oral dental radiographic film and film packets一Manufacturer specifications
Each packet shall contain one or more sheets of radiographic film, together with the components that limit film bending and provide a light-tight enclosure.
When X-ray attenuation is provided by an internal mechanism, a sheet of lead foil or other material with equivalent X-ray attenuation characteristics shall be included in each packet.
If attenuation is provided by an external mechanism, this shall be clearly stated on the package and the recommended method shall be included in the instructions for use.
The covering of the packets shall have high visibility under the recommended safelight ilumination.
The edges of the packets should be smoothly rounded and sufficiently blunt to avoid discomfort to the patient.Each packet shall be provided with a means for easily unwrapping film.
If present, the lead foil or equivalent material shall be positioned on that side of the film intended to face away from the radiation source. A material other than lead shall provide the same level of attenuation.
NOTE 1 The lead foil of 0,038 mm or equivalent material provides protection from back scatter radiation to allow 19 lp/mm. Thicker foils can be used but do not provide any significant improvement in image quality or shielding.
NOTE 2 Alternatively, a radiopaque number on the front of each packet can be used to indicate exposure technique error on a processed film.
The packets should be able to withstand the moisture in a mouth during an X-ray procedure and shall be able to be disinfected with a liquid disinfectant.
NOTE Concern regarding the possible transmission of communicable diseases has introduced the need to disinfect film packets prior to processing in dental practice. Protection from damage by the disinfection solution can be achieved by using a protective barrier or plastic foil overwrap on each packet. The process of disinfection and the necessary precautions to be taken in the handling of packets and film fall outside the scope of this International Standard.
At least six unopened packages of film packets shall be obtained for testing. Each test shall be performed on samples from three separate packages. Approximately 50 packets will be needed from each package for testing. Should a product be supplied with fewer packets per package, a proportionately larger number of packages shall be obtained for testing.BS EN ISO 3665 pdf download.
