BS EN ISO 3665:2013 pdf download

BS EN ISO 3665:2013 pdf download.Photography – Intra-oraldental radiographic film and film packets — Manufacturer specifications.
5.2.5 Film identification of the radiation side of the processed film
The film shall have an indicator at or near one edge denoting the side Intended to be towards the radiation source. A preferred means is an embossed dot with the raised portion indicating the irradiated side
NOTE An alternative means used by some manufacturers Is to place radiopaque numbers on the packet The number can be read correctly on the irradiated side of the film.
5.2.6 Sensilometrlc properties of the film
5.2.6.1 The film shall exhibit a uniform response to radiation.
52,6.2 The speed ciassification shall be in accordance with ISO 5799
5.2.6.3 The average adient in accordance with ISO 5799 shall be eater than 1.50.
5.2.7 Base plus fog density at the point of manufacture
Base plus fog density of the film shall be no greater than 0.25.
NOTE This requirement applies only to the manufacturer of the flEa. The manufacturer shall retain testing data and results, should national bodies require venIecatlon for audit purposes.
5.2.8 Film expiry date
The manufacturer shall use a maximum base plus fog density of 0,40 to set the expiry date of the film. NOTE A manufacturer’s recommended monobath process may produce an increase in fog value of 0.06.
5.3 Packet requirements
5.3.1 General
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.
It attenuation is provided by an external mechanism, this shall be clearly stated on the package and the recommended method shall be mcluded in the instructions for use.
The covering of the packets shall have high visibility under the recommended safeliglit illumination.
The edges of the packets should be smooth4y rounded and suffic1ently 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 rnatenal provides protection from back scatter radiation to allow 19 Ipmm. Thicker foils can be used but do not provide any significant improvement in image quabty or shielding.
NOTE 2 Alternatively, a radiopaque number on the front of each packet can be used to mdicate exposure technique error on a processed film.
5.3.2 Packet width and length
The maximum width or length of the packets shall not be more than 4.0 mm greater than the corresponding
width or length of the film This does not apply to the holding tab attached to the packet.
5.3.3 Packet thickness
The maximum thickness of the packet not counting any tab used for posaioning shall be 2.0 mm, For interproximal lm, the tab shall have a minimum length and width ot 20 mm.
5.3.4 Moisture protection
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 daeases has introduced the need to disinfect film packets prior to processing in dental practice. Protection from damage by the disinfection solution can be acJ’iieved by using a pro(ective barner 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.
6 Sampling, inspection and testing
6,1 Sampling
At least six unopened packages of film packets shall be obtained for testing. Each test shall be performed on samples from three separate packages. Approxwnately 50 packets will be needed from each package for testing. Should a product be supplied with fewer packets per package, a propoflionatety larger number of packages shall be obtained for testing.
The films shall be stored in accordance with the manufacturer’s recommendations.
6.2 Inspection
Visual inspection shall be used to determine compliance with 5.2.5 and 5.3.
6.3 Testing
6.3.1 Base plus fog density, fIlm speed and average gradient
Three independent determinations of base plus fog density, film speed and average gradient shall be made
using the methods descnbed in ISO 5799. using film from at least three separate packages.
For base plus fog density, each film shall comply with the requirements given in 5.2.7 and 5.2.8.
For film speed and average gradient, take the average of the three determinations as the test result. Each determinahon, however, shall not differ from the average by more than ±20 %.
6.3.2 &ze numbers
The length, width and corner radius of a film from three separate film packages shall be measured by means of a ruler with 0,5 mm calibrations, or by other means of at least equivalent accuracy.
Size numbers shall be deten’nined from Table 2.