EN ISO 3665:2013

Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011)

ISO 3665:2011 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. It specifies the sensitometric characteristics of the film/process systems, the physical characteristics of the film and packets, and it describes packaging and labelling requirements.
ISO 3665:2011 is applicable to intra-oral dental radiographic film for manual or automatic processing. It does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed primarily by reflected light.

Fotografie - Intraorale dentale Röntgenfilme und Filmpackungen - Herstellerangaben (ISO 3665:2011)

Diese Internationale Norm beschreibt ein System zur Einteilung intraoraler Röntgenfilme aufgrund der Empfindlichkeit des Film/Entwicklungssystems und der Filmgröße. Die Norm legt die sensitometrischen Eigenschaften des Film/Entwicklungssystems, die physikalischen Eigenschaften des Films und der Einzelfilmpackungen fest und beschreibt die Anforderungen an die Einzelfilmpackung und die Kennzeichnung.
Diese Internationale Norm gilt für intraorale zahnärztliche Röntgenfilme zur manuellen oder automatischen Verarbeitung. Sie gilt nicht für Filme, die zur Belichtung durch Verstärkerfolien vorgesehen sind oder für Filme, die vorrangig für die Auflicht-Betrachtung bestimmt sind.

Photographie - Film et paquets de films pour la radiographie dentaire intrabuccale - Spécifications (ISO 3665:2011)

Fotografija - Intraoralni dentalni radiografski film in zavoji filma - Specifikacije proizvajalca (ISO 3665:2011)

Standard ISO 3665:2011 vzpostavlja sistem za klasifikacijo intraoralnega radiografskega filma po hitrosti sistema filma/postopka in po velikosti filma. Določa senzitometrične lastnosti sistemov filma/postopka, fizikalne lastnosti filma in paketov ter opisuje zahteve za pakiranje in označevanje. Standard ISO 3665:2011 se uporablja za intraoralni dentalni radiografski film za ročno ali avtomatsko obdelavo. Ne uporablja se za filme, namenjene izpostavljenosti zaslonom s fluorescenčno ojačitvijo, ali za filme, primarno namenjene ogledu z odbito svetlobo.

General Information

• Status: Published
• Publication Date: 19-Mar-2013
• Withdrawal Date: 29-Sep-2013
• ICS: 37.040.25 - Radiographic films
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Mar-2013
• Due Date: 29-Jun-2014
• Completion Date: 20-Mar-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 3665:2013 - Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011)

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2013
Fotografija - Intraoralni dentalni radiografski film in zavoji filma - Specifikacije
proizvajalca (ISO 3665:2011)
Photography - Intra-oral dental radiographic film and film packets - Manufacturer
specifications (ISO 3665:2011)
Fotografie - Intraorale dentale Röntgenfilme und Filmpackungen - Herstellerangaben
(ISO 3665:2011)
Photographie - Film et paquets de films pour la radiographie dentaire intrabuccale -
Spécifications (ISO 3665:2011)
Ta slovenski standard je istoveten z: EN ISO 3665:2013
ICS:
37.040.25 Radiografski filmi Radiographic films
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 3665
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2013
ICS 37.040.25
English Version
Photography - Intra-oral dental radiographic film and film
packets - Manufacturer specifications (ISO 3665:2011)
Photographie - Film et paquets de films pour la Fotografie - Intraorale dentale Röntgenfilme und
radiographie dentaire intrabuccale - Spécifications (ISO Filmpackungen - Herstellerangaben (ISO 3665:2011)
3665:2011)
This European Standard was approved by CEN on 1 March 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3665:2013: E
worldwide for CEN national Members.

Contents Page
Foreword . 3

Foreword
The text of ISO 3665:2011 has been prepared by Technical Committee ISO/TC 42 “Photography” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 3665:2013 by
Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by September 2013, and conflicting national standards shall be
withdrawn at the latest by September 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 3665:2011 has been approved by CEN as EN ISO 3665:2013 without any modification.

INTERNATIONAL ISO
STANDARD 3665
Third edition
2011-09-01
Photography — Intra-oral dental
radiographic film and film packets —
Manufacturer specifications
Photographie — Film et paquets de films pour la radiographie dentaire
intrabuccale — Spécifications
Reference number
ISO 3665:2011(E)
©
ISO 2011
ISO 3665:2011(E)
COPYRIGHT PROTECTED DOCUMENT
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii    © ISO 2011 – All rights reserved

ISO 3665:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 3665 was prepared by Technical Committee ISO/TC 42, Photography, in collaboration with Technical
Committee ISO/TC 106, Dentistry.
This third edition cancels and replaces the second edition (ISO 3665:1996), which has been technically revised.
The following significant changes have been made from the second edition.
— In 7.2, the elevated temperature storage test and storage abuse test have been removed and replaced by a
requirement for manufacturers to clearly stipulate the shipping, handling, and storage conditions required,
ensuring that the diagnostic quality of the film is maintained up to the expiry date of the film.
— In 5.2.7, the base plus fog density has been reviewed and a maximum level has been set for the point
of manufacture.
— In 5.2.8, the base plus fog density has been reviewed and a maximum has been set for the manufacturer
to use in order to set the expiry date of the product.
— In 7.3, in recognition that background radiation can reduce the expiry date of a film, information to this
effect has been included.
— In Table 1, the requirements for C speed film have been removed, as use of this film is no longer justified
on radiological and clinical grounds.
— In 7.2, the requirements for film sizes have been rationalized to conform with current manufacturing practice.
— In 7.1, no requirement for a colour coding system for films has been included; instead it is the responsibility
of the manufacturer to provide a clear explanation in the instructions if a colour coding system is used.
— In 7.1, films requiring the use of an external attenuation device have been included.
INTERNATIONAL STANDARD  ISO 3665:2011(E)
Photography — Intra-oral dental radiographic film and film
packets — Manufacturer specifications
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. It specifies the sensitometric characteristics of
the film/process systems, the physical characteristics of the film and packets, and it describes packaging and
labelling requirements.
This International Standard is applicable to intra-oral dental radiographic film for manual or automatic
processing. It 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 referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 1, Geometric Product Specifications (GPS) — Standard reference temperature for geometrical product
specification and verification
ISO 5-2, Photography and graphic technology — Density measurements — Part 2: Geometric conditions for
transmittance density
ISO 5-3, Photography and graphic technology — Density measurements — Part 3: Spectral conditions
ISO 554, Standard atmospheres for conditioning and/or testing — Specifications
ISO 5799, Photography — Direct-exposing medical and dental radiographic film/process systems —
Determination of ISO speed and ISO average gradient
ISO 8374, Photography — Determination of ISO safelight conditions
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 18906, Imaging materials — Photographic films — Specifications for safety film
3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
expiry date
date, set by the manufacturer, beyond which the manufacturer does not guarantee the quality of the product
when handled, shipped and stored according to his instructions
3.2
gray
Gy
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 that it produces
NOTE Gy = 1 J/kg of air (equivalent to 114,5 R or to 0,029 5 C/kg).
ISO 3665:2011(E)
3.3
packet
receptacle containing one or more radiographic films intended for intra-oral use
3.4
package
receptacle containing multiple packets
4  Film and packet classifications
4.1  Film speed groups
The 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 — Speed groups
Speed group Speed range
(Gy × 10 )
D 14,0 to 27,9
E 28,0 to 55,9
F 56,0 to 111,9
4.2  Film size numbers
The size of intra-oral radiographic film shall be designated in terms of size numbers as given in Table 2.
Table 2 — Film sizes
Dimensions in millimetres
Size number Dimensions of film Approximate radius of corners
(tol. ±0,5) (tol. ±2)
0 22,0 × 35,0 6
1 24,0 × 40,0 6
a
1A 24,0 × 30,0 6
2 30,5 × 40,5 6
3 27,0 × 54,0 6
4 57,0 × 76,0 8
a
4A 54,0 × 70,0 8
a
5 40,0 × 50,0 8
a
These sizes are not common worldwide sizes but do exist in some markets.
4.3  Packet dimensions
The maximum width and length are designated in Tables 3 and 4.
2    © ISO 2011 – All rights reserved

ISO 3665:2011(E)
Table 3 — Packet maximum width
Dimensions in millimetres
Size number Maximum width of film Maximum width of packet
0 22,5 26,5
1 24,5 28,5
a
1A 24,5 28,5
2 31,0 35,0
3 27,5 31,5
4 57,5 61,5
a
4A 54,5 58,5
a
5 40,5 44,5
a
These sizes are not common worldwide sizes but do exist in some markets.
Table 4 — Packet maximum length
Dimensions in millimetres
Size number Maximum length of film Maximum length of packet
0 35,5 39,5
1 40,5 44,5
a
1A 30,5 34,5
2 41,0 45,0
3 54,5 58,5
4 76,5 80,5
a
4A 70,5 74,5
a
5 50,5 54,5
a
These sizes are not common worldwide sizes but do exist in some markets.
5  Requirements
5.1  Symbols
The symbols used shall be in accordance with ISO 15223-1.
5.2  Film requirements
5.2.1  Film type
The film shall be of the safety type defined in ISO 18906 and shall be housed within the light-tight enclosure.
5.2.2  Film corner dimensions
Due to the manufacturing process for the packet, there may be a slight ledge or step on the film itself. The step
shall be no greater than 0,2 mm (see Figure 1).
ISO 3665:2011(E)
X
Key
X enlarged view of the film chip
1 size 2 film
2 step
NOTE Maximum step 0,2 mm.
Figure 1 — Film corner characteristics
5.2.3  Film thickness
Film thickness shall not be greater than 0,25 mm.
5.2.4  Film safelight sensitivity
When testing a film by means of the procedures described in ISO 8374, no portion of the film exposed to the
safelight recommended by the manufacturer shall have any visible or measurable difference in density when
compared to that portion not exposed to the safelight.
4    © ISO 2011 – All rights reserved

ISO 3665:2011(E)
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  Sensitometric properties of the film
5.2.6.1  The film sha
...