prEN ISO 22248
(Main)Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems (ISO 22248:2020)
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems (ISO 22248:2020)
This document specifies a method of testing the laser-induced ignition and damage of medical beam delivery systems to allow checking of suitable products according to the classification system.
NOTE 1 Take care when interpreting these results, since the direct applicability of the results of this test method to the clinical situation has not been fully established.
NOTE 2 Users of products tested by this method are cautioned that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, the power settings and modes of beam delivery need to be explicitly stated.
CAUTION — This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.
Laser und Laseranlagen - Prüfverfahren für die laserinduzierte Zerstörschwelle - Einteilung von medizinischen Strahlführungssystemen (ISO 22248:2020)
Lasers et équipements associés aux lasers - Méthodes d'essai du seuil d'endommagement provoqué par laser - Classification des systèmes de transmission de faisceau médical (ISO 22248:2020)
Laserji in laserska oprema - Preskusne metode za ugotavljanje praga poškodbe, povzročene z laserjem - Razvrstitev sistemov odmerkov medicinskega žarka (ISO 22248:2020)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2024
Laserji in laserska oprema - Preskusne metode za ugotavljanje praga poškodbe,
povzročene z laserjem - Razvrstitev sistemov odmerkov medicinskega žarka (ISO
22248:2020)
Lasers and laser-related equipment - Test methods for laser-induced damage threshold -
Classification of medical beam delivery systems (ISO 22248:2020)
Laser und Laseranlagen - Prüfverfahren für die laserinduzierte Zerstörschwelle -
Einteilung von medizinischen Strahlführungssystemen (ISO 22248:2020)
Lasers et équipements associés aux lasers - Méthodes d'essai du seuil
d'endommagement provoqué par laser - Classification des systèmes de transmission de
faisceau médical (ISO 22248:2020)
Ta slovenski standard je istoveten z: prEN ISO 22248
ICS:
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
INTERNATIONAL ISO
STANDARD 22248
First edition
2020-11
Lasers and laser-related equipment —
Test methods for laser-induced
damage threshold — Classification of
medical beam delivery systems
Lasers et équipements associés aux lasers — Méthodes d'essai du seuil
d'endommagement provoqué par laser — Classification des systèmes
de transmission de faisceau médical
Reference number
ISO 22248:2020(E)
©
ISO 2020
ISO 22248:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 22248:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 4
5 Significance and use of the test. 4
6 Apparatus . 4
6.1 General . 4
6.2 Containment box . 6
6.3 Specimen holder . 7
6.4 Lasers and beam delivery systems . 7
6.5 Power meter . 7
6.6 Gas supply system . 7
6.7 Environment . 8
6.7.1 Ambient air conditions . 8
6.7.2 Oxygen enriched atmospheres . 8
6.8 Smoke evacuation device . 8
7 Reagents and materials . 8
8 Preparation of test specimens . 9
9 Preparation of apparatus . 9
10 Test methods .10
10.1 General conditions .10
10.2 Testing during laser irradiation .10
10.3 Testing during laser transmission .11
11 Classification .12
11.1 General .12
11.2 Irradiation ignition testing (I) .13
11.3 Transmission ignition and destruction testing (T/D) .13
11.3.1 Transmission ignition testing (T) .13
11.3.2 Transmission destruction testing (D) .14
12 Test report .16
Bibliography .18
ISO 22248:2020(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 9, Laser and electro-optical systems.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
ISO 22248:2020(E)
Introduction
Fire in an operating room is the most dangerous situation for patient and staff. Besides electrosurgical
devices and endoscopic light sources, even surgical lasers can be ignition sources for drapes, gowns
and tracheal tubes. This risk was identified very early and several ISO standards for laser proof
materials have been published. The medical beam delivery system itself, however, was out of focus.
Due to the increasing market on the one hand and necessity for cost reduction in health care on the
other hand fibres have come into the market with a risk of self-ignition of the core or cladding material.
Furthermore with reinvention of fibre-applicator-systems for contact application or integrated diffusor
systems they have an increased risk for self-ignition due to high absorption. This document elaborates
reproducible test parameters for medical beam delivery systems.
INTERNATIONAL STANDARD ISO 22248:2020(E)
Lasers and laser-related equipment — Test methods
for laser-induced damage threshold — Classification of
medical beam delivery systems
1 Scope
This document specifies a method of testing the laser-induced ignition and damage of medical beam
delivery systems to allow checking of suitable products according to the classification system.
NOTE 1 Take care when interpreting these results, since the direct applicability of the results of this test
method to the clinical situation has not been fully established.
NOTE 2 Users of products tested by this method are cautioned that the laser will be wavelength sensitive and
tested at the wavelength for which it is intended to be used. If tested using other wavelengths, the power settings
and modes of beam delivery need to be explicitly stated.
CAUTION — This test method can involve hazardous materials, operations and equipment. This
document provides advice on minimizing some of the risks associated with its use but does not
purport to address all such risks. It is the responsibility of the user of this document to establish
appropriate safety and health practices and to determine the applicability of regulatory
limitations prior to use.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 13694, Optics and photonics — Lasers and laser-related equipment — Test methods for laser beam
power (energy) density distribution
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
afterflame
persistence of flaming of a material, under sp
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.