Standards Specific to Single Channel ECG Medical Device

R

Rini_simon

#1
Can anyone please help with which particular standard must be considered for Hand-held single channel ECG which records ECG trace by placing right and left thumb on the electrodes to diagnose AF(Atrial Fibrillation). There are no lead wires or patient cables but it has two electrodes on the hand-held unit itself..
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Super Moderator
#2
There is no standard in the IEC series. The current ECG standards (IEC 60601-2-25, IEC 60601-2-27 and IEC 60601-2-47) are all intended for different applications. Although some agencies or regulatory reviewers might reference these standards, if you check the scope you will find (I am 99% sure) your device is excluded.

Instead you would be back to basics drawing up your own standard. In this regard, the ECG standards provide a valuable reference and many of the requirements could be derived from the standards or modified for your application. IEC 60601-2-47 is the closest standard so it might be the best reference.

I would go through each requirement and decide if it is appropriate, appropriate with modification, or not relevant for your application. For example, tests require the ability to handle ±300mVdc offset without distortion. The 300mVdc comes from ECG electrodes. Maybe if there are no electrodes, the dc offset will be smaller, ±50mV is reasonable. You should still test, but limits are modified for your application.

For AF, maybe frequency response of 0.67 - 40Hz could be modified to 1.5Hz - 30Hz if it can be shown that AF is limited to certain frequencies and the motion artifact needs heavier filtering.

For arrhythmia detection, you could ignore all database tests in IEC 60601-2-47 except those focusing on arrhythmia.

Again, you don't need to use these standards, but you need to meet the high level regulatory requirement which is to have evidence that your device detects AF (as defined by you) under expected normal conditions of use.
 
Thread starter Similar threads Forum Replies Date
D Customer requirements on specific standards Various Other Specifications, Standards, and related Requirements 5
Sidney Vianna Sector specific Information Security ISO Management System Standards IEC 27001 - Information Security Management Systems (ISMS) 1
T Combining Sector Specific Quality Standards - TS 16949, AS9100 and ISO 9001 Other ISO and International Standards and European Regulations 3
P Specific requirements for filtering in Medical Device Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Sidney Vianna Sector Specific Standards based on ISO 9001 as a baseline requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Sidney Vianna Advice from ISO/TC 176 for Sector specific standards Other ISO and International Standards and European Regulations 0
A Chinese Standards - Specific deviations in adoption of various IEC standards ISO 13485:2016 - Medical Device Quality Management Systems 2
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 5
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
placebo_master How to comprehend the paragraph architecture of OSHA standards in 1910 Subpart S Occupational Health & Safety Management Standards 6
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
M Periodically verifying revision levels of published standards Other ISO and International Standards and European Regulations 4
S Which ISO Standards to Purchase - EN ISO and/or ISO Other Medical Device Related Standards 1
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
N How to validate Regulations and Standards? ISO 13485:2016 - Medical Device Quality Management Systems 12
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
E Comparison of Respiratory Protective Equipment Standards (China Standard Compare with EU standard of EN149 Occupational Health & Safety Management Standards 2
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
A Industry Standards for Cosmetic Inspection Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
S MDR GSPR Standards EU Medical Device Regulations 1
S Class 1 and 2 changes in CM standards (aerospace industry) Federal Aviation Administration (FAA) Standards and Requirements 0
S 316 Stainless Steel Standards Other Medical Device Related Standards 0
U Is there any website out there that summarizes all relevant standards? Medical Device and FDA Regulations and Standards News 1
M Packaging standards - ASTM vs ISTA Other Medical Device Related Standards 1
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
M Why are EU harmonized particular standards so old & out-of-date? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
M MDR harmonized standards EU Medical Device Regulations 7
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
C Appendix Z in Harmonised Standards? EU Medical Device Regulations 15
Ajit Basrur Corporate management standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 6
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
Q Standards for Shipping by Sea US Food and Drug Administration (FDA) 2
N Database that lists labs accredited to ASTM / ANSI standards Various Other Specifications, Standards, and related Requirements 6
SANTHSH API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
P Citing EN standards Other Medical Device Related Standards 6
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
Govind Informational ISO COVID-19 response: freely available ISO standards Other ISO and International Standards and European Regulations 1
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4

Similar threads

Top Bottom