Standard No.:	YY 0885-2013
English Name:	Medical electrical equipment―Part 2:Particular requirements for the safety,including essential performance of ambulatory electrocardiographic systems
Chinese Name:	医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求
Chinese Classification:	C39    Medical electronic equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.55 11.040.55    Diagnostic equipment 11.040.55
Issued by:	China Food and Drug Administration
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	superseded
Superseded by:	YY 9706.247-2021 Medical electrical equipment-Part 2-47:Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
Superseded on:	2024-5-1
Language:	English
File Format:	PDF
Word Count:	16500 words
Price(USD):	490.00
Delivery:	via email in 1~5 business day

本标准规定了适用于由动态记录仪和回放设备组成（两者均可包括分析功能）的动态心电图系统的专用安全要求。能连续分析心电图、提供连续或者部分记录的设备或系统，均适用于本标准的安全要求。无论设备或系统是否具有完整的重新分析功能，记录单元和分析单元是否独立，记录和分析是否能够同时进行，设备后系统采用何种存储媒介，均在本标准的范围内。
由GB10793-2000《医用电气设备第2部分：心电图机安全专用要求》和GB9706.25-2005《医用电气设备第2-27部分：心电监护设备安全专用要求》所覆盖的医用电气设备以及不能对心电图进行连续记录和分析的设备不在本标准的范围内。