NF EN ISO 11990-1

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Standards
NF EN ISO 11990-1

NF EN ISO 11990-1

November 2011

Standard Cancelled

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1 : tracheal tube shaft

ISO 11990-1:2011 specifies a method of testing the continuous wave (cw) resistance of the shaft of a tracheal tube designed to resist ignition by a laser. It is not applicable to other components of the system, such as the inflation system and cuff, which are defined in ISO 11990-2:2010. ISO 11990-1:2011 can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use conditions. However, the results of this test can be used as one element of a fire risk assessment which takes into account all factors pertinent to an assessment of the hazard of a particular end use.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2011

Number of pages

20 p.

Reference

NF EN ISO 11990-1

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

31.260 Optoelectronics. Laser equipment

Classification index

S95-170-1

Print number

1 - 28/10/2011

International kinship

ISO 11990-1:2011

European kinship

EN ISO 11990-1:2011

Sumary

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1 : tracheal tube shaft

ISO 11990-1:2011 can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use conditions. However, the results of this test can be used as one element of a fire risk assessment which takes into account all factors pertinent to an assessment of the hazard of a particular end use.

Replaced standards (1)

NF EN ISO 11990

March 2004

Standard Cancelled

Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts

ISO 11990:2003 specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube. Other components of the system, such as the inflation system and cuff, are outside the scope of ISO 11990:2003. The specified test method shall be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions and shall not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions. However, results of this test may be used as elements of a fire risk assessment which takes into account all the factors which are pertinent to an assessment of the hazard of a particular end use. Caution should be observed in interpreting these results, since the direct applicability of the result of this test method to the clinical situation has not been fully established.

Standard replaced by (1)

NF EN ISO 11990-1

June 2015

Standard Cancelled

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1 : tracheal tube shaft

Le présent document spécifie une méthode d'essai de la résistance à un laser fonctionnant en régime continu d'un tube trachéal conçu pour résister à l'ignition provoquée par un laser. Il ne s'applique pas aux autres éléments du système, comme le système de gonflage et le ballonnet qui sont définis dans la NF EN ISO 11990-2. Le présent document peut être utilisé pour mesurer et décrire les propriétés des matériaux, produits ou assemblages par rapport à la chaleur et à la flamme, en conditions de laboratoire contrôlées. Il ne décrit pas, ni n'évalue le danger ou le risque de feu pour les matériaux, produits ou assemblages en conditions réelles de feu. Cependant, les résultats de cet essai peuvent constituer des éléments d'évaluation du risque de feu prenant en compte tous les facteurs pertinents pour l'évaluation du danger dans le cadre d'un usage particulier. Il vient à l'appui des exigences essentielles de la Directive Nouvelle approche 93/42/CEE relative aux dispositifs médicaux.

Table of contents

Avant-propos
iv
Introduction
v
1 Domaine d'application
1
2 Références normatives
1
3 Termes et définitions
2
4 Principe
3
5 Portée et utilisation de l'essai
3
6 Appareillage
3
6.1 Système d'alimentation en gaz
3
6.2 Enceinte de confinement
4
6.3 Évacuation de la fumée
5
6.4 Lasers et systèmes d'émission
5
6.5 Analyseur d'oxygène
6
7 Réactifs et matériaux
6
8 Préparation des éprouvettes
6
9 Préparation de l'appareillage
7
10 Mode opératoire
7
11 Interprétation des résultats
9
12 Rapport d'essai
9
Bibliographie
10

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