Photography - Intra-oral dental radiographic film - Specification

Establishes a system for the classification of intra-oral radiographic film. Specifies the sensitometric characteristics of the film systems and the physical characteristics of the film.

Photographie - Film pour la radiographie dentaire intrabuccale - Spécifications

Fotografija - Intraoralni radiografski film - Specifikacija

Vzpostavlja sistem za klasifikacijo intraoralnih radiografskih filmov. Določa senzitometrične lastnosti filmskih sistemov in fizikalne lastnosti filma.

General Information

Status
Withdrawn
Publication Date
30-May-2011
Withdrawal Date
23-Jan-2014
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
15-Jan-2014
Due Date
07-Feb-2014
Completion Date
24-Jan-2014

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INTERNATIONAL
STANDARD
Second edition
1996-12-15
Photography - Intra-oral dental
radiographic film - Specification
Photographie - Film pour Ia radiographie dentaire intrabuccale -
Spkcifica tions
Reference number
ISO 3665: 1996(E)

---------------------- Page: 1 ----------------------
ISO 3665:1996(E)
@ ISO
Introduction
The principal changes in this revision of ISO 3665 pertain to Speed,
safelight sensitivity and two added film sizes.
Speed is determined by measurements expressed in grays rather than
coulombs per kilogram of air. This Change in units was made to adopt the
recommendation of the International Commission of Radiation Units and
Measurements to use the gray as a measure of absorbed X and gamma
radiation as opposed to coulombs per kilogram of air (a unit which simply
measures ionization). The constant in the equation for determining Speed
and the limits for the Speed groups have been correspondingly changed so
that the classification of products by Speed in this International Standard
essentially remains unchanged.
Manufacturers are now required to specify a suitable safelight Screen or
filter to be used with the product. This enables an “ISO safelight condition”
as described in ISO 8374 to be realised; i.e. a safelight condition that will
provide no measurable or visible effect upon a sensitized emulsion.
The conditions of the storage test have been kept unchanged from the first
edition of ISO 3665, and are in line with long established and proven
testing conditions in the photographic industry. The storage test is primarily
a test to determine the degree of sensitometric changes that might result
from normal transient conditions which could be encountered during
shipment and storage. Although the 70 % relative humidity conditions
stated in this International Standard are beyond those suggested for
storage by most manufacturers, experience has shown that such
conditions, on a transient basis, would still allow for acceptable diagnostic
radiographs. This test allows for the measurement of the sensitometric
effects of such transient conditions.
A storage abuse test for abnormal conditions has been added as annex A.

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This page intentionally left blank

---------------------- Page: 3 ----------------------
ISO 3665: 1996(E)
INTERNATIONAL STANDARD @ ISO
Photography - Intra-oral dental radiographic film -
Specification
1 Scope
This International Standard establishes a System for the classification of intra-oral radiographic film by the Speed of
the film/process System and by the size of the film. lt specifies the sensitometric characteristics of the fiIm/process
Systems and the physical characteristics of the film and packets; it also describes packaging and labelling
,
requirements.
This International Standard is applicable to intra-oral dental radiographic film for manual or automatic processing. lt
does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed
primarily by reflected light.
2 Normative references
The following Standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All Standards are subject to
revision, and Parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the Standards indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
ISO 1: 1975, Standard reference temperature for industrial length measurements.
ISO 5-2: 1991, Photography - Density measurements - Part 2: Geometrie conditions for transmission density.
ISO 543:1990, Photography - Photographit films - Specifica tions for safety film.
ISO 554: 1976, Standard atmospheres for conditioning and/or testing - Specifica tions.
ISO 5799:1991, Photography - Direct-exposing medical and dental radiographic film/process Systems -
Determination of ISO Speed and ISO average gradient.
ISO 8374: 1986, Photography - Determination of ISO safeligh t conditions.
3 Definitions
For the purposes of this International Standard, the following definitions apply.
3.1 packet: Receptacle containing one or more radiographic films intended primarily for intra-oral use.
3.2 package: Receptacle containing multiple packets.

---------------------- Page: 4 ----------------------
ISO 3665: 1996(E) @ ISO
3.3 gray (Gyl)): That dose of X and/or gamma radiation absorbed by 1 kg of air which imparts 1 J of initial kinetic
energy to those charged particles which it produces.
4 Classification
4.1 ISO Speed groups
The ISO Speed of the film/process System shall be designated in terms of Speed groups as specified in ISO 5799
and given in table 1.
Table 1 - ISO Speed groups
ISO Speed rangei)
ISO Speed group
(Gy x IO*)-’
I I
7,oto 13,9
C
D 14,oto 27,9
28,0 to 55,9
E
56,0 to 111,9
F
4.2 ISO size numbers
The size of intra-oral radiographic film shall be designated in terms of ISO size numbers as given in table 2.
Table 2 - Film sizes
Dimensions in millimetres
Dimensions of film Approximate radius of corners
ISO size number
(tob + 0,5) (toi. Ik 2,O)
0 22,0 x 35,0
IA 24,0 x 30,O
1 24,0 x 40,O
2 ’) 30,5 x 40,5
3 27,0 x 54,0
4 57,0 x 76,0
4A 54,0 x 70,o
5 40,o x 50,o
1 1) The former size of 31 mm X 41 mm is, in practice, tut to 30,5 mm X 40,5 mm.
5 Requirements
5.1 General
Esch packet shall contain one or more sheets of radiographic film, a sheet of lead foil or other material with
5.1.1
equivalent X-ray attenuation characteristics, together with components which limit film bending and provide a light-
tight enclosure.
1) 1 Gy = 1 Jlkg of air (equivalentto 114,5 R orto 0,029 5 C/kg).
2

---------------------- Page: 5 ----------------------
@ ISO ISQ 3665: 1996(E)
51.2 The covering of the packets shall have high visibility under the recommended safelight illumination, shall be
resistant to the ingress of moisture, and shall be able to be disinfected with a liquid disinfectant.
51.3 Edges of the packets shall be smoothly rounded and sufficiently blunt to avoid the Sensation by the Patient
,
that the film packet is cutting into his/her mucosa.
51.4 Esch packet shall be provided with a means for easily unwrapping the film.
51.5 The lead foil or other equivalent material shall be positioned on that side of the film intended to face away
from the radiation Source.
5.1.6 The film shall be of the safety type as defined in ISO 543 and shall be housed within the light-tight enclosure.
5.2 Identification of the irradiated side of the packet
Esch packet shall have an indicator that teils which side should face the radiation Source. An embossed dot, located
near the edge of the film, is the preferred method of identification. Its raised Portion indicates the side facing the
radiation Source. This is usually combined with a second means of identification on the side not facing the radiation
Source, such as a coloured tab with or without the words “opposite side toward tube ”.
5.3 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.
5.4 Uniformity
The film shall exhibit a uniform response to radiation.
5.5 Evaluation before elevated temperature storage test
The base plus fog density of films of Speed groups C and D shall be less than 0,252)
The base plus fog density of films of Speed groups E and F shall be less than 0,35.
The ISO Speed shall be within the designated ISO Speed group of the film.
The ISO average gradient shall be greater than 150.
5.6 Evaluation after elevated temperature storage test
The base plus fog density of films of Speed groups C and D shall be less than 0,30.9
The base plus fog density of films of Speed groups E and F shall be less than 0,40.
The Speed and average grad ient shall not differ by more than 20 % from the ISO Speed and ISO average gradient
valu es, as determined before the elevated temperature storage test.
2) A manufacturer ’s recommended monobath process may produce an increase in fog value of 0,05.

---------------------- Page: 6 ----------------------
ISO 3665:1996( E) @ ISO
5.7 Safelight sensitivity
When testing a film by means of the procedures described in ISO 8374, no portion of the film exposed to a safelight
shall have any visible or measurable differente in density when compared to that portion not exposed to the
safelight.
5.8 Packet and lead foil dimensions
The thickness of unprocessed film shall not be greater than 0,25 mm.
The thickness of the lead foil shall not be less than 0,05 mm. If a lead-equivalent material is used, then the
thickness of the material used shall provide attenuation at least equivalent to 0,05 mm of lead.
NOTE 1 It is recommended to collect lead foils during processing for environmentally safe recycling or disposal.
The maximum length or width of the packets shall not be more than 4,0 mm greater than the corresponding length
or width of the film. This does not apply to any holding tab attached to the packet.
The maximum thickness of the packet shall be 2,0 mm. For interproximal film, the Bite wing3) tab shall have a
minimum length and width of 20 mm.
6 Sampling, inspection and testing
6.1 Sampling
At least six unopened packages of film packets shall be obtained for testing. lt is recommended that each test be
performed on samples from three separate packages, but a further three packages will also be required for testing
to be performed on unopened packages subjected to
...

SLOVENSKI STANDARD
SIST ISO 3665:2011
01-julij-2011
Fotografija - Intraoralni radiografski film - Specifikacija
Photography - Intra-oral dental radiographic film - Specification
Photographie - Film pour la radiographie dentaire intrabuccale - Spécifications
Ta slovenski standard je istoveten z: ISO 3665:1996
ICS:
37.040.25 Radiografski filmi Radiographic films
SIST ISO 3665:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST ISO 3665:2011

---------------------- Page: 2 ----------------------

SIST ISO 3665:2011
INTERNATIONAL
STANDARD
Second edition
1996-12-15
Photography - Intra-oral dental
radiographic film - Specification
Photographie - Film pour Ia radiographie dentaire intrabuccale -
Spkcifica tions
Reference number
ISO 3665: 1996(E)

---------------------- Page: 3 ----------------------

SIST ISO 3665:2011

---------------------- Page: 4 ----------------------

SIST ISO 3665:2011
ISO 3665:1996(E)
@ ISO
Introduction
The principal changes in this revision of ISO 3665 pertain to Speed,
safelight sensitivity and two added film sizes.
Speed is determined by measurements expressed in grays rather than
coulombs per kilogram of air. This Change in units was made to adopt the
recommendation of the International Commission of Radiation Units and
Measurements to use the gray as a measure of absorbed X and gamma
radiation as opposed to coulombs per kilogram of air (a unit which simply
measures ionization). The constant in the equation for determining Speed
and the limits for the Speed groups have been correspondingly changed so
that the classification of products by Speed in this International Standard
essentially remains unchanged.
Manufacturers are now required to specify a suitable safelight Screen or
filter to be used with the product. This enables an “ISO safelight condition”
as described in ISO 8374 to be realised; i.e. a safelight condition that will
provide no measurable or visible effect upon a sensitized emulsion.
The conditions of the storage test have been kept unchanged from the first
edition of ISO 3665, and are in line with long established and proven
testing conditions in the photographic industry. The storage test is primarily
a test to determine the degree of sensitometric changes that might result
from normal transient conditions which could be encountered during
shipment and storage. Although the 70 % relative humidity conditions
stated in this International Standard are beyond those suggested for
storage by most manufacturers, experience has shown that such
conditions, on a transient basis, would still allow for acceptable diagnostic
radiographs. This test allows for the measurement of the sensitometric
effects of such transient conditions.
A storage abuse test for abnormal conditions has been added as annex A.

---------------------- Page: 5 ----------------------

SIST ISO 3665:2011
This page intentionally left blank

---------------------- Page: 6 ----------------------

SIST ISO 3665:2011
ISO 3665: 1996(E)
INTERNATIONAL STANDARD @ ISO
Photography - Intra-oral dental radiographic film -
Specification
1 Scope
This International Standard establishes a System for the classification of intra-oral radiographic film by the Speed of
the film/process System and by the size of the film. lt specifies the sensitometric characteristics of the fiIm/process
Systems and the physical characteristics of the film and packets; it also describes packaging and labelling
,
requirements.
This International Standard is applicable to intra-oral dental radiographic film for manual or automatic processing. lt
does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed
primarily by reflected light.
2 Normative references
The following Standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All Standards are subject to
revision, and Parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the Standards indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
ISO 1: 1975, Standard reference temperature for industrial length measurements.
ISO 5-2: 1991, Photography - Density measurements - Part 2: Geometrie conditions for transmission density.
ISO 543:1990, Photography - Photographit films - Specifica tions for safety film.
ISO 554: 1976, Standard atmospheres for conditioning and/or testing - Specifica tions.
ISO 5799:1991, Photography - Direct-exposing medical and dental radiographic film/process Systems -
Determination of ISO Speed and ISO average gradient.
ISO 8374: 1986, Photography - Determination of ISO safeligh t conditions.
3 Definitions
For the purposes of this International Standard, the following definitions apply.
3.1 packet: Receptacle containing one or more radiographic films intended primarily for intra-oral use.
3.2 package: Receptacle containing multiple packets.

---------------------- Page: 7 ----------------------

SIST ISO 3665:2011
ISO 3665: 1996(E) @ ISO
3.3 gray (Gyl)): That dose of X and/or gamma radiation absorbed by 1 kg of air which imparts 1 J of initial kinetic
energy to those charged particles which it produces.
4 Classification
4.1 ISO Speed groups
The ISO Speed of the film/process System shall be designated in terms of Speed groups as specified in ISO 5799
and given in table 1.
Table 1 - ISO Speed groups
ISO Speed rangei)
ISO Speed group
(Gy x IO*)-’
I I
7,oto 13,9
C
D 14,oto 27,9
28,0 to 55,9
E
56,0 to 111,9
F
4.2 ISO size numbers
The size of intra-oral radiographic film shall be designated in terms of ISO size numbers as given in table 2.
Table 2 - Film sizes
Dimensions in millimetres
Dimensions of film Approximate radius of corners
ISO size number
(tob + 0,5) (toi. Ik 2,O)
0 22,0 x 35,0
IA 24,0 x 30,O
1 24,0 x 40,O
2 ’) 30,5 x 40,5
3 27,0 x 54,0
4 57,0 x 76,0
4A 54,0 x 70,o
5 40,o x 50,o
1 1) The former size of 31 mm X 41 mm is, in practice, tut to 30,5 mm X 40,5 mm.
5 Requirements
5.1 General
Esch packet shall contain one or more sheets of radiographic film, a sheet of lead foil or other material with
5.1.1
equivalent X-ray attenuation characteristics, together with components which limit film bending and provide a light-
tight enclosure.
1) 1 Gy = 1 Jlkg of air (equivalentto 114,5 R orto 0,029 5 C/kg).
2

---------------------- Page: 8 ----------------------

SIST ISO 3665:2011
@ ISO ISQ 3665: 1996(E)
51.2 The covering of the packets shall have high visibility under the recommended safelight illumination, shall be
resistant to the ingress of moisture, and shall be able to be disinfected with a liquid disinfectant.
51.3 Edges of the packets shall be smoothly rounded and sufficiently blunt to avoid the Sensation by the Patient
,
that the film packet is cutting into his/her mucosa.
51.4 Esch packet shall be provided with a means for easily unwrapping the film.
51.5 The lead foil or other equivalent material shall be positioned on that side of the film intended to face away
from the radiation Source.
5.1.6 The film shall be of the safety type as defined in ISO 543 and shall be housed within the light-tight enclosure.
5.2 Identification of the irradiated side of the packet
Esch packet shall have an indicator that teils which side should face the radiation Source. An embossed dot, located
near the edge of the film, is the preferred method of identification. Its raised Portion indicates the side facing the
radiation Source. This is usually combined with a second means of identification on the side not facing the radiation
Source, such as a coloured tab with or without the words “opposite side toward tube ”.
5.3 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.
5.4 Uniformity
The film shall exhibit a uniform response to radiation.
5.5 Evaluation before elevated temperature storage test
The base plus fog density of films of Speed groups C and D shall be less than 0,252)
The base plus fog density of films of Speed groups E and F shall be less than 0,35.
The ISO Speed shall be within the designated ISO Speed group of the film.
The ISO average gradient shall be greater than 150.
5.6 Evaluation after elevated temperature storage test
The base plus fog density of films of Speed groups C and D shall be less than 0,30.9
The base plus fog density of films of Speed groups E and F shall be less than 0,40.
The Speed and average grad ient shall not differ by more than 20 % from the ISO Speed and ISO average gradient
valu es, as determined before the elevated temperature storage test.
2) A manufacturer ’s recommended monobath process may produce an increase in fog value of 0,05.

---------------------- Page: 9 ----------------------

SIST ISO 3665:2011
ISO 3665:1996( E) @ ISO
5.7 Safelight sensitivity
When testing a film by means of the procedures described in ISO 8374, no portion of the film exposed to a safelight
shall have any visible or measurable differente in density when compared to that portion not exposed to the
safelight.
5.8 Packet and lead foil dimensions
The thickness of unprocessed film shall not be greater than 0,25 mm.
The thickness of the lead foil shall not be less than 0,05 mm. If a lead-equivalent material is used, then the
thickness of the material used shall provide attenuation at least equivalent to 0,05 mm of lead.
NOTE 1 It is recommended to collect lead foils during processing for environmentally safe recycling or dispo
...

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