EN ISO 11990-1:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
02-02-2019
29-10-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Significance and use of the test
6 Apparatus
7 Reagents and materials
8 Preparation of test specimen
9 Preparation of apparatus
10 Test procedure
11 Interpretation of results
12 Test report
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
(Medical Devices)
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.
Committee |
CEN/TC 123
|
DevelopmentNote |
Supersedes EN ISO 11990. (08/2011) Supersedes UNE EN ISO 11990-1. (12/2014)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
UNI EN ISO 11990-1:2015 | Identical |
UNE-EN ISO 11990-1:2012 | Identical |
SS-EN ISO 11990-1:2014 | Identical |
ISO 11990-1:2011 | Identical |
NEN EN ISO 11990-1 : 2014 | Identical |
NBN EN ISO 11990-1 : 2014 | Identical |
DIN EN ISO 11990-1:2016-02 | Identical |
UNE-EN ISO 11990-1:2014 | Identical |
NF EN ISO 11990-1 : 2015 | Identical |
BS EN ISO 11990-1:2014 | Identical |
NS EN ISO 11990-1 : 2014 | Identical |
I.S. EN ISO 11990-1:2014 | Identical |
UNI EN ISO 11990-1 : 2011 | Identical |
PN EN ISO 11990-1 : 2015 | Identical |
SN EN ISO 11990-1 : 2015 | Identical |
ISO 14408:2016 | Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information |
ISO 11990-2:2010 | Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs |
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 |
IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
ISO/TR 11991:1995 | Guidance on airway management during laser surgery of upper airway |
ISO 11145:2016 | Optics and photonics Lasers and laser-related equipment Vocabulary and symbols |
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