IEC 60601-2-25 Reference to 60601-1 2nd Edition

EMengineer

Involved In Discussions
#1
Hi,

Standard 60601-2-25:1993+A1:1999 is valid until 2018, but it has reference to old void 60601-1:1988 2nd edition medical standard. So, can I use 2nd ed. 601 as general standard of 601-2-25 for ecg testing? I don't have old 601 so I wonder if it is worth buying one. Or 2nd and 3rd ed. 601 tests (defibrillation tests, leakage measurement) used for ecg approval are the same?
 
Elsmar Forum Sponsor

Pads38

Trusted Information Resource
#2
It somewhat depends what you are trying to do. The electrical tests are all but identical from Edition 2 to 3, (some terms have changed - enclosure leakage = touch current) but fundamentally they remain the same.

What you may find useful is IEC TR 62348:2006. This contains tables that 'map' between the requirements of Edition 2 and 3 (both directions). Although the 2006 version is marked as withdrawn it is still available as a free download.

https://webstore.iec.ch/publication/20459
 
Thread starter Similar threads Forum Replies Date
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
R Hand transmitted vibration 9.6.3 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Different methods of achievement of the isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Unused SIP/SOPs - IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Transformer Requirements - IEC 60601-1 vs. IEC 61558-2-15 IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T Clearance and Creepage according to Subclause 8.9.1 for MOPP IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601-1 and IEC 60601-2-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601-1-2 EMC Tables IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
T Iec 60601 Impedance and current-carrying capability IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Bookmarking my security protected IEC 60601-1 .pdf file IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E ECG device without ECG REPORTS - IEC 60601-2-25: 2011 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601 7.1.3 Durability of Markings - Methylated Spirit or Ethanol? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C ABS plastic : which IEC 60601-1 tests to redo? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Q Isolation/Insulation Diagrams - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-2-2 - Defib-proof test amendment to base standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
P Testing lab in India IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Kuldeep Singh Electromagnetic Compatibility Test IEC 60601-1-2: 2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
K IEC 60601-1 Ed. 3.1 b:2012: Replaced IEC 60601-1 Ed. 3.1 en:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Impact test on glass touch controller IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D IEC 60601 for a Software only Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Is IEC 60601 applicable to our smart bed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom