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naSRPS EN ISO 22248:2023

Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems (ISO 22248:2020)

General information

40.60     Apr 18, 2024

ISS

Z172

European Norm

31.260  

English  

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

Life cycle

NOW

PROJECT
naSRPS EN ISO 22248:2023
40.60 Close of voting
Apr 18, 2024

Related project

Adopted from prEN ISO 22248 IDENTICAL

Adopted from ISO 22248:2020 IDENTICAL