EN ISO 11810:2015

• Abstract:

  ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying surgical drapes and other patient-protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition.; All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard.; The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant items; NOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.

• Status: Published
• Publication Date: 22-Dec-2015
• Withdrawal Date: 29-Jun-2016
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.99 - Other protective equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: CEN/TC 123 - Lasers and photonics
• Drafting Committee: CEN/TC 123 - Lasers and photonics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Dec-2015
• Completion Date: 23-Dec-2015
• Directive: Not Harmonized2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive:

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  Not Harmonized93/42/EEC - Medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 11810:2016 - Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)

• Replaces: EN ISO 11810-2:2009 - Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
• Effective Date: 30-Dec-2015
• Replaces: EN ISO 11810-1:2009 - Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)
• Effective Date: 30-Dec-2015
• Refers: IEC 60825-1:2014 - Safety of laser products - Part 1: Equipment classification and requirements
• Effective Date: 25-Aug-2026
• Refers: ISO 11146-1:2005 - Lasers and laser-related equipment — Test methods for laser beam widths, divergence angles and beam propagation ratios — Part 1: Stigmatic and simple astigmatic beams
• Effective Date: 25-Aug-2026
• Refers: ISO 80000-4:2006 - Quantities and units — Part 4: Mechanics
• Effective Date: 25-Aug-2026
• Refers: ISO 11145:2006 - Optics and photonics — Lasers and laser-related equipment — Vocabulary and symbols
• Effective Date: 09-Feb-2026
• Refers: EN 10207:1991/A1:1997 - Steels for simple pressure vessels - Technical delivery requirements for plates, strips and bars
• Effective Date: 28-Jan-2026
• Refers: EN 15998:2010 - Glass in building - Safety in case of fire, fire resistance - Glass testing methodology for the purpose of classification
• Effective Date: 28-Jan-2026
• Consolidated By: ISO 11810:2015 - Lasers and laser-related equipment — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers — Primary ignition, penetration, flame spread and secondary ignition
• Effective Date: 12-Feb-2026

EN ISO 11810:2015 - Overview

Standard Reference: EN ISO 11810:2015
Title: Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
Organization: CEN / ISO

EN ISO 11810:2015 specifies a standardized test method and classification to evaluate the laser-induced flammability and laser resistance of surgical drapes and patient-protective covers. It applies to disposable and reusable, woven and non‑woven materials that claim laser resistance, and can also be used to assess non-laser-resistant items. The standard is intended to support risk assessment for laser surgery; it is not a general fire-safety specification and does not address other ignition sources.

Key topics and technical requirements

• Scope and applicability: Materials for surgical drapes and patient covers; wavelength sensitivity and testing at the intended laser wavelength are emphasized.
• Tested hazards: Primary ignition, penetration (laser-through), flame spread and secondary ignition are the focus.
• Classification system: Provides classification categories (e.g., laser‑induced primary ignition (I), resistance to penetration (P), laser‑induced secondary ignition (SI)) to report performance.
• Apparatus and setup: Defines required test equipment and environment - containment box, specimen holder, laser system and power meter, gas supply, smoke evacuation and ambient/oxygen conditions.
• Specimen handling: Sampling, conditioning and specimen preparation rules for disposable and reusable products.
• Test procedure and reporting: Stepwise test methods, limits and required test-report content; users must document laser wavelength, power settings and delivery mode when reporting test results.
• Exclusions: Measurement of specular reflectance (specular beam reflection) is not covered and must be considered separately by users.

Practical applications and users

Who uses EN ISO 11810:2015:

• Manufacturers of surgical drapes and patient-protective covers seeking validated laser‑resistance claims
• Accredited test laboratories performing flammability and penetration testing for medical textiles
• Medical device regulatory and conformity assessment bodies (supports EU Directive 93/42/EEC essential requirements)
• Hospital procurement and clinical safety/risk assessors evaluating materials for laser surgery environments
• Product designers and quality managers integrating laser-safety performance into product labeling and specifications

Benefits:

• Standardized, reproducible evaluation of laser-induced fire hazards
• Clear classification to compare products and support risk assessments in laser surgery
• Guidance to test at the intended laser wavelength and to report power/mode for transparency

Related standards

• EN ISO 11810-1:2009 and EN ISO 11810-2:2009 (superseded by this edition)
• ISO/IEC directives referenced for test-method development and reporting

Keywords: EN ISO 11810:2015, laser resistance, surgical drapes, patient protective covers, laser-induced flammability, primary ignition, penetration, secondary ignition, laser surgery safety, medical device testing.