SBS - The best value in QMS software

IEC 60601 - Essential performance c.2.34

W

W3r0nika

Starting to get Involved
#1
#1
Hello,
C.2.34 Does the use of the medical device depend on essential performance?
I don't really know how to understand this point despite reading 60601. So we make electrosurgical units. Is this the point to write the risks of a neutral electrode? I understand that from 60601. (section 201.4.3) Please help and explain :(
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
M

monoj mon

Quite Involved in Discussions
#2
#2
W3r0nika said:
Hello,
C.2.34 Does the use of the medical device depend on essential performance?
I don't really know how to understand this point despite reading 60601. So we make electrosurgical units. Is this the point to write the risks of a neutral electrode? I understand that from 60601. (section 201.4.3) Please help and explain :(
Click to expand...
Read this article carefully, you will get your answer. First, you will need to list the performance(s) of the device and then decide whether the device failure (by missing the intended performance level) would harm the patient or not. I don't know what kind of electrosurgical device you manufacturer, so I am unable to define any essential performance for your device. Read the article and the example provided in there for a better understanding of what would be the potential "essential performance" of your device.

1593741504332.png
 
P

PaulGr

Registered
#3
#3
From your question, it looks like you are completing the questionnaire from ISO14971:2007? Please keep in mind that this questionnaire is informative and helps you identifying characteristics and hazards that are applicable. In the new ISO14971 (2019) this section is removed and moved to the TR document. So don't bother too much about answering all questions but focus on a good description of these characteristics and related hazards. The fact that your system requires a neutral electrode with all the related risks is indeed i.m.o. a characteristic that could affect safety.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
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
Z In which country is essential to have and IEC 60601 CB Report? Other Medical Device Related Standards 0
D IEC 60601-1 - Essential performance doesn't make sense IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
D IEC 60601-1 - Performance limits for essential performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K IEC 60601-1 and Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M IEC 60601 - Limits of agreement as Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D IEC 60601-2-44: 202.101 Immunity Testing of Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L "Potential" Essential Performance in IEC 60601-2-54 (Definition) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
A Essential Performance in IEC 3rd edition of the 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-2-30 - Is it mandatory to claim alarms? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
R IEC 60601-1 - Power Supply Cords (Section 8.11.3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Complex IEC 60601-1 gap assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
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 7
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
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

Similar threads

Top Bottom