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خرید استاندارد AAMI EC12

AAMI EC12:2000/(R)2015

Disposable ECG electrodes

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The AAMI standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices.

Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGs).

خرید استاندارد AAMI EC12

AAMI EC12:2000/(R)2015
Disposable ECG electrodes
standard by Association for the Advancement of Medical Instrumentation, 01/06/2005

https://www.techstreet.com/standards/aami-ec12-2000-r-2015?product_id=1642226

Full Description AAMI EC12

This standard establishes contains minimum labeling, safety and performance requirements; test methods; and terminology for disposable electrocardiographic (ECG) electrodes.

فهرست مطالب Disposable ECG electrodes

Contents
Page
Committee representation……………………………………………………………………………………………………………….iv
Foreword……………………………………………………………………………………………………………………………………….v
1 Scope……………………………………………………………………………………………………………………………………..1
1.1 Inclusions………………………………………………………………………………………………………………………1
1.2 Exclusions……………………………………………………………………………………………………………………..1
2 Normative references ……………………………………………………………………………………………………………….1
3 Definitions and abbreviations……………………………………………………………………………………………………..1
4 Requirements ………………………………………………………………………………………………………………………….2
4.1 Labeling requirements …………………………………………………………………………………………………….2
4.2 Performance requirements ………………………………………………………………………………………………2
4.2.1 Packaging and shelf life………………………………………………………………………………………2
4.2.2 Electrical performance………………………………………………………………………………………..3
4.3 Safety requirements………………………………………………………………………………………………………..4
4.3.1 Biological response ……………………………………………………………………………………………4
4.3.2 Pre-attached leadwire safety ……………………………………………………………………………….4
4.4 Adhesive performance (duration of use)…………………………………………………………………………….4
5 Tests ………………………………………………………………………………………………………………………………………4
5.1 Labeling ………………………………………………………………………………………………………………………..4
5.2 Performance ………………………………………………………………………………………………………………….4
5.2.1 Packaging and shelf life………………………………………………………………………………………4
5.2.2 Tests for electrical performance …………………………………………………………………………..4
5.3 Safety……………………………………………………………………………………………………………………………6
5.3.1 Biological response evaluation …………………………………………………………………………….6
5.3.2 Pre-attached leadwire safety ……………………………………………………………………………….6
5.4 Adhesive performance (duration of use)…………………………………………………………………………….7
Annexes
A Rationale for the development and provisions of this standard ……………………………………………………….8
B Cited references …………………………………………………………………………………………………………………….14
Tables
1 Summary of labeling requirements ……………………………………………………………………………………………..2
2 Summary of performance requirements ………………………………………………………………………………………3
Figures
1 Test circuit for offset instability/internal noise determination …………………………………………………………..5
2 Defibrillation overload test circuit (all capacitor and resistor values have a tolerance
of ± 10%) ………………………………………………………………………………………………………………………………..5

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