DIN EN ISO 11990-2018
激光和激光相关设备. 气管轴和气管管套耐激光性的测定(ISO 11990-2018); 德文版本EN ISO 11990-2018

Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018); German version EN ISO 11990:2018

DIN EN ISO 11990-2018 发布历史

This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist ignition by a laser. NOTE 1 When interpreting these results, the attention of the user is drawn to the fact that the direct applicability of the results of this test method to the clinical situation has not been fully established. NOTE 2 The attention of the users of products tested by this method is drawn to the fact that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, explicitly state the power settings and modes of delivery. CAUTION: This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

DIN EN ISO 11990-2018由德国标准化学会 DE-DIN 发布于 2018-12。

DIN EN ISO 11990-2018 在中国标准分类中归属于: L51 激光器件，在国际标准分类中归属于: 11.040.10 麻醉、呼吸和复苏设备,31.260 光电子学、激光设备。

DIN EN ISO 11990-2018 发布之时，引用了标准

• DIN EN 60601-2-22-2015 医疗电气设备. 第2-22部分: 外科, 美容, 治疗和诊断激光设备基本安全和基本性能的特殊要求 (IEC 60601-2-22-2007 + A1-2012); 德文版本EN 60601-2-22-2013
• DIN EN 60825-1-2015 激光产品安全.第1部分:设备分类和要求(IEC 60825-1-2014);德文版本EN 60825-1-2014
• DIN EN ISO 5361-2017 麻醉和呼吸设备.气管导管和连接器(ISO 5361-2016);德文版本EN ISO 5361-2016
• DIN EN ISO 11145-2016 光学和光子学.激光器和激光器相关设备.词汇和符号(ISO 11145-2016).德文版本EN ISO 11145-2016
• DIN EN ISO 11146-1-2005 激光和激光相关设备.激光束宽度、发散角和束扩散率的试验方法.第1部分:无象散和简单象散束
• DIN EN ISO 14408-2016 激光手术用气管导管.标记和伴随信息的要求(ISO 14408-2016);德文版本EN ISO 14408-2016
• IEC 60601-2-22-2007 医疗电气设备.第2-22部分:外科、整容、治疗和诊断用激光设备基本安全和基本性能的特殊要求
• IEC 60825-1-2014 激光产品的安全.第1部分:设备分类和要求
• ISO/IEC GUIDE 99-2007 计量学的国际词汇.基本与一般概念与相关术语(VIM)
• ISO 5361-2016 麻醉和呼吸设备.气管导管和连接件
• ISO 11145-2016 光学和光子学.激光和激光设备.词汇和符号
• ISO 11146-1-2005 激光和激光相关设备.激光束宽度、发散角和束扩散率的试验方法.第1部分:无象散和简单象散束
• ISO 11810-2015 激光和激光相关设备. 手术单和/或病人防护覆盖物抗激光试验方法和分类. 初级点燃, 穿透, 火焰蔓延和次级点燃
• ISO/TR 11991-1995 上呼吸道激光手术中通气管理指南
• ISO 14408-2016 激光手术用气管掐管.标识及附带信息要求

DIN EN ISO 11990-2018的历代版本如下：

• 2011年11月 DIN EN ISO 11990-1-2011 激光器及激光器相关设备.测定气管导管的激光阻抗力.第1部分:气管导管传动轴(ISO 11990-1-2011);德文版本EN ISO 11990-1-2011
• 2016年02月 DIN EN ISO 11990-1-2016 激光器及激光器相关设备.测定气管导管的激光阻抗力.第1部分:气管导管传动轴(ISO 11990-1-2011);德文版本EN ISO 11990-1-2014
• 2010年12月 DIN EN ISO 11990-2-2010 光学和光学仪器.气管柄激光抗性的测定.第2部分:气管套管袖带(ISO 11990-2-2010).德文版本EN ISO 11990-2-2010
• 2016年02月 DIN EN ISO 11990-2-2016 光学和光学仪器.气管柄激光抗性的测定.第2部分:气管套管袖带(ISO 11990-2-2010).德文版本EN ISO 11990-2-2014
• 2018年12月 DIN EN ISO 11990-2018 激光和激光相关设备. 气管轴和气管管套耐激光性的测定(ISO 11990-2018); 德文版本EN ISO 11990-2018

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标准号

DIN EN ISO 11990-2018

发布日期

2018年12月

实施日期

废止日期

无

中国标准分类号

L51

国际标准分类号

11.040.10;31.260

发布单位

DE-DIN

引用标准

DIN EN 60601-2-22-2015 DIN EN 60825-1-2015 DIN EN ISO 5361-2017 DIN EN ISO 11145-2016 DIN EN ISO 11146-1-2005 DIN EN ISO 11810-2016 DIN EN ISO 14408-2016 IEC 60601-2-22-2007 IEC 60825-1-2014 ISO/IEC GUIDE 99-2007 ISO 5361-2016 ISO 11145-2016 ISO 11146-1-2005 ISO 11810-2015 ISO/TR 11991-1995 ISO 14408-2016 93/42/EWG-1993-06

被代替标准

DIN EN ISO 11990-2017 DIN EN ISO 11990-1-2016 DIN EN ISO 11990-2-2016

适用范围

This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist ignition by a laser. NOTE 1 When interpreting these results, the attention of the user is drawn to the fact that the direct applicability of the results of this test method to the clinical situation has not been fully established. NOTE 2 The attention of the users of products tested by this method is drawn to the fact that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, explicitly state the power settings and modes of delivery. CAUTION: This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.