oSIST prEN ISO 22248:2024

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

• Status: Not Published
• Public Enquiry End Date: 29-Apr-2024
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 26-Feb-2024
• Due Date: 15-Jul-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN ISO 22248 - Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems (ISO 22248:2020)

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 22248:2024
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
oSIST prEN ISO 22248:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 22248:2024

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oSIST prEN ISO 22248:2024
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

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oSIST prEN ISO 22248:2024
ISO 22248:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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oSIST prEN ISO 22248:2024
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 .
...