Standard 33866

Name
ISO 11810 Second edition 2015-12-15
Recognition date
2016-06-27
Scope
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.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.