BS EN ISO 3665-2013 PDF

Full title and description

BS EN ISO 3665:2013 — Photography — Intra‑oral dental radiographic film and film packets — Manufacturer specifications. This document is the British adoption of EN ISO 3665:2013 (which adopts ISO 3665:2011) and specifies classification, sensitometric and physical characteristics, packaging and labelling requirements for intra‑oral dental radiographic film and single‑film packets intended for manual or automatic processing.

Abstract

Establishes a system for classification of intra‑oral radiographic film by film/process system speed and by film size, defines required sensitometric characteristics and physical properties for film and packets, and sets sampling, inspection, packaging and marking requirements for manufacturers. The standard excludes films intended for exposure with fluorescent intensifying screens and films intended primarily for reflected‑light viewing.

General information

• Status: Adopted/confirmed as BS EN ISO 3665:2013 (national adoption of EN ISO 3665:2013).
• Publication date: 30 June 2013 (BS publication / national adoption date).
• Publisher: British Standards Institution (BSI) — text identical to EN ISO 3665:2013 which in turn is identical to ISO 3665:2011 (ISO/TC 42 photography).
• ICS / categories: 37.040.25 (Radiographic films / Image technology, photography).
• Edition / version: BS EN ISO 3665:2013 (adoption of EN ISO 3665:2013; base ISO edition ISO 3665:2011).
• Number of pages: Typically published as 14–16 pages in national adoptions (BS edition listed at 16 pages).

Scope

This standard applies to intra‑oral dental radiographic film and single‑film packets intended for dental radiography. It specifies how manufacturers shall classify film/process systems by speed and size, the required sensitometric characteristics (speed and average gradient), minimum physical properties of film and packet construction, sampling and inspection procedures, and mandatory marking/instruction information to accompany the product. It does not apply to films designed for use with fluorescent intensifying screens or films primarily viewed by reflected light.

Key topics and requirements

• Classification system for intra‑oral film by film/process system speed and by film size (film speeds expressed per ISO/photographic practice).
• Sensitometric characteristics — specified ISO speed and ISO average gradient criteria for acceptability.
• Physical characteristics of film and packet construction (dimensions, backing, edges, identification marks).
• Sampling, inspection and test methods manufacturers must use to demonstrate conformity with the standard.
• Requirements for packaging, labelling and instructions for use — marking of film speed, size, processing mode (manual/automatic), lot identification and storage/handling notes.
• Exclusions and intended use statements — not intended for screen‑film systems or reflected‑light viewing applications.

Typical use and users

Primary users are dental radiographic film manufacturers and their quality/technical departments, product compliance and regulatory teams, dental equipment and consumable suppliers, dental imaging laboratories, and procurement/specification engineers who set acceptance criteria for dental radiographic films supplied to clinics. Dental clinics and dental radiography service providers consult the standard indirectly through product labelling and manufacturer declarations.

Related standards

ISO 3665 forms part of the photography/radiography family of standards developed under ISO/TC 42. Closely related documents cited or used with ISO 3665 include ISO 5799 (direct‑exposing medical and dental radiographic film/process systems — determination of ISO speed and ISO average gradient) and ISO 8374 (determination of safe‑light conditions) as well as national/adopted EN versions where applicable. The EN adoption text is identical to the ISO base standard.

Keywords

intra‑oral radiographic film, dental X‑ray film, film packets, sensitometry, film speed classification, ISO 3665, EN ISO 3665, BS EN ISO 3665, manufacturer specifications, radiographic film packaging, dental imaging standards.

FAQ

Q: What is this standard?

A: BS EN ISO 3665:2013 is the British adoption of EN ISO 3665:2013, which is textually identical to ISO 3665:2011; it provides manufacturer specifications for intra‑oral dental radiographic film and film packets (classification, sensitometric and physical requirements, packaging and marking).

Q: What does it cover?

A: It covers classification by film/process system speed and size, required sensitometric (speed/gradient) characteristics, physical film and packet properties, sampling and inspection methods, and labelling/packaging and instruction requirements for intra‑oral dental films. It excludes films intended for use with intensifying screens or for reflected‑light viewing.

Q: Who typically uses it?

A: Film manufacturers, product compliance and QA teams, dental imaging labs, dental consumables suppliers, and procurement/specification staff in healthcare organisations. Clinicians rely on manufacturer declarations that reference the standard.

Q: Is it current or superseded?

A: The ISO base document is ISO 3665:2011 (third edition); EN ISO 3665:2013 and BS EN ISO 3665:2013 are national/adopted versions published in 2013 and were current as national adoptions at publication. Users should verify with their national standards body for any subsequent amendments or withdrawal/revision notices before relying on the standard for regulatory compliance.

Q: Is it part of a series?

A: It sits within the ISO/TC 42 photography portfolio and is used together with other imaging/radiography standards such as ISO 5799 (speed/gradient determination) and ISO 8374 (safelight conditions) and other related film/process control documents. National EN adoptions are often published with identical text.

Q: What are the key keywords?

A: intra‑oral film, dental radiography, film packets, sensitometry, film speed, ISO 3665, manufacturer specifications, packaging, labelling, sampling and inspection.