YY 0885-2013 Replaced Industry standards-Medicine

YY 0885-2013 Medical electrical equipment—Part 2:Particular requirements for the safety,including essential performance of ambulatory electrocardiographic systems

Publish Date: 2013-10-21 Implement Date: 2014-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0885-2013

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical electronic instruments and equipment

ICS Name: Diagnostic equipment

Publish Date: 2013-10-21

Implement Date: 2014-10-01

Pages: 33 pages

Scope

Except for the content described below, this chapter of the general standard applies.
〖BT3〗〖STFZ〗1.1 Scope
Addition:
This dedicated standard specifies the dedicated safety requirements applicable to the 〖HTH〗 dynamic electrocardiogram system 〖HT〗 defined in 2.101.
The following types of systems are within the scope of this standard:
a)〖WB〗〖ZK（#〗 Systems that can continuously record and analyze electrocardiograms and provide essentially identical results when conducting a complete reanalysis of the electrocardiogram. This system can first record and store the 〖HTH〗 electrocardiogram 〖HT〗 and then analyze it in a separate unit, or perform both recording and analysis simultaneously. This standard does not address the type of storage medium used;
b)〖DW〗 Systems that can provide continuous analysis and partial or limited recording, but cannot conduct a complete reanalysis of the 〖HTH〗 electrocardiogram 〖HT〗.
Systems meeting any of the above types are subject to the safety requirements of this standard.〖ZK）〗
If the dynamic electrocardiogram system provides automatic electrocardiogram analysis, the minimum performance requirements for measurement and analysis functions specified in this standard apply. Medical electrical equipment covered by GB 10793—2000 and GB 9706.25—2005 are not within the scope of this standard.
This standard does not apply to systems that cannot conduct continuous recording and analysis of the 〖HTH〗 electrocardiogram 〖HT〗 (for example, "intermittent event recorders").
〖BT3〗〖STFZ〗1.2 Purpose
Replacement:
The purpose of this dedicated standard is to establish dedicated requirements for the safety and basic performance of the 〖HTH〗 dynamic electrocardiogram system 〖HT〗.