ISO 22248:2020

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 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

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
Foreword
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electrotechnical standardization.
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different types of ISO documents should be noted. This document was drafted in accordance with the
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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
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iv © ISO 2020 – All rights reserved

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 specified test conditions, after the ignition source has
been removed
[SOURCE: ISO 11810:2015, 3.1]
3.2
afterflame time
length of time for which a material continues to flame, under specified test conditions, after the ignition
source has been removed
[SOURCE: ISO 11810:2015, 3.2]
3.3
afterglow
persistence of glowing of a material, under specified test conditions, after cessation of flaming or, if no
flaming occurs, after the ignition source has been removed
[SOURCE: ISO 11810:2015, 3.3]
3.4
afterglow time
time during which a material continues to glow, under specified test conditions, after cessation of
flaming or, if no flaming occurs, after the ignition source has been removed
[SOURCE: ISO 11810:2015, 3.4]
3.5
beam diameter
d
diameter of a circular aperture in a plane perpendicular to the beam axis that contains 95 % of the total
beam power (energy)
[SOURCE: ISO 11145:2018, 3.3.1, modified — Value of contained total beam power set to 95 % and
Note 1 to entry removed.]
3.6
beam cross-sectional area
A
smallest completely filled area containing 95 % of the total beam power (energy)
[SOURCE: ISO 11145:2018, 3.6.1, modified — Value of contained total beam power set to 95 % and
Note 1 to entry removed.]
3.7
combustion
any continuing burning
...