YY/T 1635-2018 Active Industry standards-Medicine

YY/T 1635-2018 Multi-channels electrophysiology recording system

Publish Date: 2018-12-20 Implement Date: 2020-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1635-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical electronic instruments and equipment

ICS Name: X-ray imaging equipment

Publish Date: 2018-12-20

Implement Date: 2020-01-01

Pages: 25 pages

Scope

This standard specifies the requirements and test methods for multi-channel physiological recorders.
This standard applies to multi-channel physiological recorders, which are used to collect surface ECG and intracardiac ECG characteristic signals of the human body, and to perform continuous recording and/or display. It depicts the waveform of each cardiac cycle and reflects the changes in the rhythm of the heart for determining the heart rhythm; the device can also have auxiliary functions such as non-invasive blood pressure monitoring, invasive blood pressure monitoring, and pulse oxygen saturation monitoring.
This standard does not apply to electrocardiographs.

Development Information

Word Count: 48 Thousand words Pages: 25 pages

Referenced Standards

GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 10793-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of electrocardiographs GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0667-2008 Medical electrical equipment—Part 2-30:Particular requirements for the safety,including essential performance,of automatic cycling non-invasive blood pressure monitoring equipment YY 0670-2008 Non-invasive automated sphygmomanometer YY 0782-2010 Medical electrical equipment—Part 2-51:Particular requirements for safety,including essential performance,of recording and analysing single channel and multichannel of electrocardiographs YY 0783-2010 Medical electrical equipment—Part 2-34:Particular requirements for the safety,including essential performance,of invasive blood pressure monitoring equipments YY 0784-2010 Medical electrical equipment—Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use YY 1139-2013 Diagnostic electrocardiographic devices

Related Standards

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GB 5579-1985 Abolished

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GB 5665-1985 Abolished

GB 5665-1985 General specification for mechanical units of medical diagnostic X-ray equipment

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GB 10151-1988 Abolished

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GB/T 10149-1988 Active

GB/T 10149-1988 Terminology and symbol for medical X-ray equipment

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GB 11239-1989 Replaced

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