Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
医用电气设备第2-13部分:麻醉工作站基本安全和基本性能的特殊要求修改1
发布日期:
2019-11-20
实施日期:
2019-11-20
EN ISO 80601-2-13于2011年发布。EN ISO 80601-2-13:2011的修改件1将更新本标准,以参考IEC 60601-1:2005(EN 60601-1:2006)和适用的附属标准。修改件1还引入了技术修改,以澄清本标准与IEC 60601-2-49之间的关系,并进一步规定附件。它修订了以下方面的要求,部分原因是发布了分别于2012年和2013年发布的对IEC 60601-1:2005及其附属标准的修订:-增加了关于可互换麻醉蒸汽输送系统的定义;-标记移动式医用电气设备的质量;-超过门槛的运动;-粗加工试验;-多个插座;-麻醉气体输送系统和麻醉呼吸系统的具体要求,包括使用说明;-氧气冲洗期间和之后的蒸汽浓度;-吸气暂停。在适当的情况下,修改件1还包括与上述修改要求相关的具体资料性附件的修改。最后,进行了一些小的编辑更新。
EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards:
— addition of a definition on interchangeable anaesthetic vapour delivery system;
— marking the mass of mobile me equipment;
— movement over a threshold;
— rough handling test;
— multiple socket-outlets;
— specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use;
— vapour concentration during and after oxygen flush;
— inspiratory pause.
Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.