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SSH EN ISO 11810:2015

Lazera dhe pajisje që lidhen me rrezet lazer - Metoda prove dhe klasifikimi për rezistencën e veshjeve kirurgjikale me rreze lazer dhe/ose të mbulesave mbrojtëse të pacientëve - Pajisja ndezëse primare, depërtimi, përhapja e flakës dhe pajisja ndezëse sekondare 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 (ISO 11810:2015)
27 tet 2016

General information

60.60     27 tet 2016

DPS

DPS/KT 215

European Norm

11.040.30     13.340.99     31.260  

anglisht  

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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.
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.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

2007/47/EC

Direktiva 2007/47/EC e Parlamentit Europian dhe e Këshillit të 5 shtator 2007 amendon Direktivën e Këshillit 90/385/EEC mbi përafrimin e ligjeve të Shteteve Anëtare në lidhje me pajisje medicinale aktive transplatuese, Direktiva e Këshillit 93/42/EEC në lidhje me pajisjet mjekësore dhe Direktivën 98/8/EC në lidhje me vendosjen e produkteve biocide në treg

Life cycle

PREVIOUSLY

Replaces
SSH EN ISO 11810-1:2009

Replaces
SSH EN ISO 11810-2:2009

NOW

PUBLISHED
SSH EN ISO 11810:2015
60.60 Standard published
27 tet 2016

Related project

Adopted from EN ISO 11810:2015

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