Verkkokauppa
SFS-EN ISO 11810:en
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)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SESKO ry, puh. 050 571 6048.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SESKO ry, puh. 050 571 6048.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
IEC 60825-1:2014
ISO 11145:2006 Optics and photonics -- Lasers and laser-related equipment -- Vocabulary and symbols
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
ISO 11145:2006 Optics and photonics -- Lasers and laser-related equipment -- Vocabulary and symbols
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
Tekninen komitea
Direktiivi
93/42/EEC Lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet
http://ec.europa.eu »
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet
http://ec.europa.eu »
Vahvistuspäivä
31.12.2015
Julkaisupäivä
19.01.2016
Painos
1
Sivumäärä
27
Julkaisun kieli
englanti