ISO 22248:2020
Lasers and laser-related equipment — Test methods for laser-induced damage threshold — Classification of medical beam delivery systems
Lasers and laser-related equipment — Test methods for laser-induced damage threshold — Classification of medical beam delivery systems
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 18
- Дата публикации:
- 12 ноября 2020 г.
- Издание:
- ISO IS 22248 edition 1 version 1
- ICS:
- 31.260
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.
Abstract
Overview
ISO 22248:2020 specifies test methods and a classification system for the laser-induced ignition and damage threshold of medical beam delivery systems. It defines a repeatable laboratory procedure to assess whether products that transmit laser energy (e.g., optical fibres, articulated arms, hollow waveguides and applicators) are susceptible to ignition, flame spread or other damage when exposed to laser irradiation. The standard emphasises reproducible test conditions and cautions that results may not fully predict clinical outcomes. It also warns about hazardous operations and oxygen‑enriched atmospheres used in testing.
Key topics and technical requirements
- Scope and purpose: Method for testing laser-induced ignition and damage of medical beam delivery systems and classifying test outcomes.
- Test environments: Tests are carried out in ambient air and in oxygen‑enriched atmospheres (notably 60% ± 2% and up to 98% ± 2% oxygen) to simulate worst‑case clinical conditions.
- Test types / classification:
- Irradiation ignition (I) - ignition from external laser irradiation of the specimen.
- Transmission ignition (T) - ignition caused by laser transmission through the specimen.
- Transmission destruction (D) - non‑ignition damage (melting, crumbling, breaking) due to absorption during transmission.
- Apparatus and setup: Requirements for a ventilated, draught‑resistant containment box, specimen holder/rack, laser source and beam delivery, power/energy meters, gas supply and oxygen control, smoke evacuation and environmental monitoring.
- Specimen preparation and testing conditions: Specimens must be prepared per manufacturer instructions; variables (wavelength sensitivity, power settings, modes of delivery) must be explicitly stated when reporting results.
- Safety considerations: CAUTION about hazardous materials, potential for intense fires (“rocket‑like” fire), toxic gases; responsibility on the user to establish safety and regulatory compliance.
- Reporting: Standard requires documentation of test conditions and results to support classification.
Applications and who uses it
ISO 22248 is used by:
- Manufacturers of medical laser fibres, applicators, handpieces and beam delivery systems for product development, risk assessment and labeling.
- Independent test laboratories performing ignition and damage threshold testing for compliance and certification.
- Regulatory and conformity assessment bodies evaluating safety of laser medical devices.
- Clinical engineers and hospital procurement teams assessing device risks in oxygen‑rich clinical environments.
- Product safety and quality teams validating designs to reduce laser‑induced fire hazards.
Relevant SEO keywords: ISO 22248, laser-induced damage threshold, medical beam delivery systems, laser ignition testing, oxygen-enriched atmosphere, laser safety, laser testing standards.
Related standards
Технические детали
- Технический комитет
- ISO/TC 172/SC 9 - Laser and electro-optical systems
- SKU
- ISO 22248:2020
Похожие стандарты
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EN ISO 22248:2026
ДействующийLasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medi…
Overview EN ISO 22248:2026 (ISO 22248:2020) is an international standard published by CEN that defines test methods for determining the laser-induced damage threshold and provides a classification sy…