MEDTEQ Articles
Various articles are provided here based on past experience and areas of interest.
All articles are what Wikipedia would call "original research", meaning they are based on experience, analysis and interpretation of the author, but should not be considered peer reviewed, fact checked, quality published literature. Always refer to the original regulation, standard or specification for final decisions, and use the material here more as a guide or prompt to promote broader thinking rather than a formal, qualified reference. For comments, suggestions and improvement, peter.selvey@medteq.jp.
- Collaterals
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ECG General
- Feb 27, 2017 ECG Filters
- Mar 25, 2017 CMRR Testing (IEC 60601-2-25, -2-27, -2-47)
- Apr 1, 2017 ECG Leads - an explanation
- Jun 9, 2017 ECGs - 3 Lead tests
- Jul 17, 2019 ECG - input impedance and noise
- May 4, 2020 ECG Low Frequency Response Impulse test (0.05Hz, 3mV/100ms test)
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General
- Jan 1, 2017 IEC 60601-1 Amendment 1 Update Summary
- Jan 1, 2017 IEC 60601-1 and accessories
- Jan 1, 2017 IEC 60601-1 Clause 4.2 - Risk Management
- Jan 1, 2017 IEC 60601-1 Clause 4.3 Essential Performance
- Jan 1, 2017 IEC 60601-1 Clause 4.4 Service Life
- Jan 1, 2017 IEC 60601-1 Clause 4.5 Alternate solutions
- Jul 10, 2019 IEC 60601-1 Defibrillator protection (design, test)
- Sep 20, 2019 Medical systems - a device based approach
- Mar 4, 2021 Li-ion batteries - the anecdotal PCM story
- Measurement
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Particulars
- Feb 2, 2017 IEC 60601-2-2 201.8.8.3 High Frequency Dielectric Strength
- Feb 2, 2017 IEC 60601-2-2 Dielectric heating
- Feb 25, 2017 IEC 60601-2-25 Update Guide (2005 to 2011 edition)
- Feb 25, 2017 IEC 60601-2-25 Overview of CTS, CSE databases
- Feb 25, 2017 IEC 60601-2-25 CSE database - test experience
- Feb 25, 2017 IEC 60601-2-25 Clause 201.8.5.5.1 Defibrillator Protection
- Feb 25, 2017 IEC 60601-2-25 Clause 201.12.4.101 Indication of Inoperable ECG
- Feb 25, 2017 IEC 60601-2-25 Clause 201.12.4.102.3.2 - Goldberger and Wilson LEADS
- Feb 27, 2017 IEC 60601-2-27 Update (2005 to 2011 edition)
- Mar 14, 2017 IEC 60601-2-34 General information
- Mar 27, 2017 IEC 60601-2-47 (AAMI/ANSI EC 57) Databases
- Apr 1, 2017 IEC 60601-2-25 Clause 201.12.4.103 Input Impedance
- Sep 21, 2018 IEC 60601-2-24 Infusion pumps - what's the story?
- Apr 19, 2023 IEC 60601-2-2 Calculator for HF insulation testing (201.8.8.3.102, 201.8.8.3.103)
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Regulatory
- Mar 25, 2017 IEC 62304 Software Development Life Cycle
- Apr 1, 2017 MDD - Retrospective application of harmonized standards: an investigation
- Apr 1, 2017 MDD Essential Requirements
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Risk Management
- Aug 15, 2018 ISO 14971: a madmans's criteria for acceptable risk
- Oct 10, 2018 The risk benefit misdirection
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Testing
- Apr 1, 2017 Defibrillator Proof Testing
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Z files (old stuff)
- Jul 10, 2019 JIS T 0601-1:2012 Transition and Deviations to IEC 60601-1:2005
- Jul 10, 2019 ISO 8185 Experience from testing