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 system for medical beam delivery systems. The standard is key for ensuring the safety and performance of products used to transmit laser energy in medical settings, such as optical fibers, articulated arms, and waveguides.
EN ISO 22248:2026 outlines rigorous procedures for testing how medical beam delivery systems withstand laser-induced ignition, flame spread, and physical damage under different environmental conditions, including oxygen-enriched atmospheres. These test results are used as the basis for a structured classification, helping manufacturers, healthcare facilities, and regulators assess the suitability of products for clinical use. Users should note that while this standard provides a consistent testing approach, results should be interpreted carefully, as real clinical scenarios may not always be fully replicated in the laboratory setting.
Key Topics
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Test Methods for Laser-Induced Damage
- Standardized procedures to expose medical beam delivery systems to laser energy.
- Protocols for both irradiation ignition (external exposure) and transmission ignition (through the device).
- Environmental conditions specified, including ambient and oxygen-enriched atmospheres.
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Product Classification System
- Clear criteria for assigning beam delivery systems to defined safety classes based on their behavior during laser testing.
- Grading according to ignition, self-extinguishing properties, and time to ignition under varied oxygen conditions.
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Specimen Preparation and Testing Apparatus
- Detailed requirements for specimen handling, pre-conditioning, and apparatus setup, ensuring test repeatability and reliability.
- Guidelines for using containment boxes, specimen holders, gas supply systems, and safety measures.
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Safety and Health Considerations
- Emphasis on risk management, personal protective equipment, and fire safety due to potential hazards from high-power lasers and oxygen-enriched environments.
Applications
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Medical Device Manufacturers
- Develop and validate compliant laser beam delivery systems.
- Demonstrate product safety and reliability for regulatory submissions.
- Inform development of reusable and single-use devices with resistance to laser-induced ignition and damage.
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Clinical and Hospital Procurement
- Compare and select medical laser delivery products based on standardized performance classifications.
- Ensure the safety of equipment used in operating rooms and other clinical environments, especially where oxygen concentrations may be elevated.
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Conformity Assessment & Regulatory Bodies
- Assess manufacturer’s claims and technical documentation against international benchmarks.
- Support market surveillance and approval processes for laser-related medical equipment.
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Research and Testing Laboratories
- Perform third-party product evaluations for compliance and innovation in laser medicine.
- Develop improvements in materials or device design based on standardized damage threshold testing.
Related Standards
For enhanced safety and performance in laser medicine, the following related standards provide additional guidance:
- ISO 13694: Optics and photonics - Laser beam power (energy) density distribution - Test methods
- ISO 11810: Lasers and laser-related equipment - Test method for laser-induced ignition of surgical drapes and other materials
- ISO/IEC Guide 99: International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
By establishing uniform test methods and a clear classification system for medical beam delivery systems, EN ISO 22248:2026 helps drive the safety, performance, and regulatory compliance of laser-based medical equipment. Adoption of this standard supports improved risk management and patient safety in medical laser applications.
