Standards and Technology

From January 2017, a new webiste has been launched to replace this website. The website includes a new article section in blog format which is searchable.  The articles below have also been transferred to the new website.  

The information here is being retained for reference. 

This section provides technical information on specific requirements in standards, based on the work that MEDTEQ has been involved in, including the general standard and also particular standards covering ECG, IBP, NIBP, Temperature, HF surgery, patient monitoring and the like. Refer to the navigation on the right side or the list below for links.

Subject Subject / Standards
IEC 60601-2-25 CSE database tests (pdf file) Provides some practical explanation for the CSE database tests 
IEC 60601-1-10 Scope (PCLC) Discusses the scope of Physiological Closed Loop Controllers
Physionet ECG databases Provides a simple download of the Physionet databases referred to in IEC 60601-2-47
JIS T 0601-1:2012 Deviations Lists the deviations as shown in Annex JC of the Japanese standard
IEC 60601-1:2005, Amendment 1 2012 Overview, Highlights, detailed list changes and discussion on essential performance
IEC 60601-2-25:2011 changes IEC 60601-2-25 (changes from IEC 60601-2-25:1993/A1:1999 + IEC 60601-2-51:2003)
IEC 60601-2-27:2011 changes IEC 60601-2-27 (changes from the 2005 edition)
Protection systems (SFC) IEC 60601-1, Clause 4.7
ECG Leads IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47, IEC 60601-2-51
ECG filters IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47, IEC 60601-2-51
HF dielectric strength tests IEC 60601-2-2, IEC 60601-2-18
HF measurements IEC 60601-2-2, IEC 60601-2-18
IBP performance tests IEC 60601-2-34
Defibrillator testing IEC 60601-1, IEC 60601-2-25, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49
Measurements around body temperature IEC 60601-1, IEC 60601-2-18, IEC 60601-2-19, IEC 60601-2-20, IEC 60601-2-21, ISO 9919
Sound level measurements (updated May 2013) IEC60601-1-8, IEC 60601-2-xx (equipment with alarms)



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As standards are becoming increasingly subjective, many requirements in standards are open to interpretation. Opinions on interpretations have been moved to a new section (Articles).