Dielectric Test for Ambulatory ECG Medical Device

R

RAGHAVENDRA A

#1
Hai,

I am having a ambulatory ECG medical device whcih is powered with 3.7V DC & the same battery is being charged from external charger ( by removing the battery from the device & charge ).
So my question here is for the operating voltage of 3.7V DC , does the device require any insulation / dielectric test is required ?

Please reply.

Regards,
Raghu
 
Elsmar Forum Sponsor
R

raymond02302

#3
Firstly, dielectric test is to verify solid insulation.
Internal impedance of component can limit patient leakage current to a acceptable value. You can demonstrate this by measuring leakage current under normal condition and single fault condition (failure of internal component), Note that patient leakage current is measured form paitent connection(ecg electrode) to encloure for interally powered equipment. If measured value does't not exceed relevant limit, there is no need to add other insulation and perform dilectric test between 3.7V and patient circuit.
Additionally, there should be sufficient spacing (air clearence and creepage distance, BI for working voltage 250 V) between enclosure and patient circuit for Holter with type F applied part.
 
Last edited by a moderator:
R

RAGHAVENDRA A

#4
Thank you Raymond,
The information that you have provided helps me in going forward w.r.t safety test.
From your response i can understand leakage current will be applicable for my equipment & dielectric is NA ( as its internally powered equipment i.e of 3.7V )

In addition to it I have few more Q :
1) Is ALARM (eITHER AUDIO OR VIDEO ) IS COMPULSARY FOR SUCH DEVICES?
2) Since it is ambulatory wearable device i am complying to 60601-2-47 , shpuld i also have to comply to 60601-2-27 ?
 
R

raymond02302

#5
1) No, Technically, If alarm system complying with IEC 60601-1-8 should be provided or not is based on your risk analysis/management. Generally, Holer does not provide such alarm system. Holter is used to record ECG single during daily life/ambulatory condition and ECG will be replay and analysed by specific software on PC to diagnose patient by doctor. From intended use above for holter, it is not used to monitor physiological parameter and indicate paitent's condition in real time. Therefore,there is no need to provide alarm system to control relevant risk due to its clinical/intended use.
2) IEC 60601-2-27 is not applicabe for amubulatory electrocardiograph, it is applicabe for ECG monitor (record and display ECG in real time in OR, ICU, ward etc to assist surgery team, doctor and nurse). Alarm system is compulsive for ECG monitor
 
Last edited by a moderator:
R

RAGHAVENDRA A

#6
Hi,
Thanks for your valuable info.
w.r.t 2nd point i.e complying to particular standards , If my intended use says that the device(wearable ambulatory ECG device) is used in both hospital & home , is that is required to comply for both 2-27 & 2-47 ?

I understand I need to comply to IEC 62304 , can the requirement be fulfilled in risk management file ? or saperate checklist has to be prepared as we do for other standard like ( 1-1 , 2-47 , 2-27 etc )
 
R

raymond02302

#7
Which standard is appliable to a device is mainly dependent on its intended use and technique used. For regular Holter, IEC 60601-2-27 is not applicable even if it can be used in hospital.
IEC 62304 deals with whole software delelopment life cycle (SDLC) not just risk management. RM is just part of it.
 
R

RAGHAVENDRA A

#8
Thank you Raymond,
Apart fromt he above query ,
Its regarding labelling.
I wanted to sell my product to european & US market.
1) Can I have a single label which suffies both requirement.
2) Is EC REP to be affixed on the device label.
3) Is there any particular to US market apart from the below mentioned details.

Please guide me if any other symbols also need to be affixed in addition to the below.

Deatils of my label ( for battery operated equipment)
a) Manufacturer trade or contact info
b) IPX level ,
c) Classification of device & applied part
d) Operating manual
e) model number , serial number
f) CE mark

Please excuse if any wrong questoins i am asking , i am very much new to this field.

Regards,
Raghavendra.a
 
Thread starter Similar threads Forum Replies Date
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
E Routine production tests - dielectric voltage withstand test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Production Line Test Brasil - High Voltage Dielectric Strenght Test Other Medical Device Regulations World-Wide 5
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Operator protection - When to apply table 7, Dielectric strength test voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Standard for Dielectric Strength Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E IEC 61010-1 Dielectric strength test of inner power supply Other ISO and International Standards and European Regulations 0
S IEC 60601-1 Electrical safety testing - Dielectric Strength Test - 8.8.3 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Leakage Current test and Dielectric strength for Battery operated ECG device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
B Dielectric Test of Battery Powered Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Transformer Compliance Testing, overheat then humidity treat, then dielectric test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C INMETRO 350 Dielectric Strength Test to IEC 60601-1 clauses 18, 19 and 20 Other Medical Device Regulations World-Wide 5
I Dielectric Test for HF Surgical Equipment (IEC 60601-2-2 clause 201.8.5.1.2) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 61010-1 - Voltage / Dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
O Is it mandatory for Medical Devices to work properly after dielectric strength tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T Tests IEC 60601-1 - Grounding Resistance, Leakage Current and Dielectric Rigidity in an automated way IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M HF/RF Generator for dielectric strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Dielectric Strength of Electroshock - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Humidity Pre-Conditioning before leakage current and dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Input to Ouput Dielectric Strength PSU IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Issues with Dielectric Strength Testing - IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R Current Limit in IEC 60601 Dielectric Strength Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Dielectric Strength of Triple Insulated Wire to comply with 2MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Internally Powered Medical Device and Dielectric Strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
D IEC 60601-2-37 - No Dielectric testing specifications? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
E Tensile test machine, tinius olsen 602 Manufacturing and Related Processes 1
M Test failure Root cause not found Customer Complaints 10
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Tip test 10° -> 5° IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Disaster Recovery Test IT (Information Technology) Service Management 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 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
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom