Proper document of SMPS used in infant warmer for IEC 60601-1 testing

K

krishnasaini19

Registered
#1
#1
I am testing an infant incubator which contains SMPS. It is an approved product and the document is also given as per IEC 62368-1:2014. Is this document valid? as I understand that IEC 62368 is for audio/video and IT equipment.
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
B

Benjamin Weber

Trusted Information Resource
#2
#2
This depends on the way the electrical insulation concept is designed. If there are only means of operator protection implemented by the power supply, then IEC 62368 compliance should be sufficient (see also figuer A.12 in 60601, ed. 3.1, and replace 60950 by 62368) . But as soon as there is a means of patient protection implemented by the power supply, you have to be very careful if 62368 compliance fullfils requirements of 60601 (test voltage for solid insulatin, creepages and clearances).

Very often the power supply is used to achieve the required 2 MOPP against mains voltage from the mains supply. If the 2 MOPP cannot be achieved by other means in the device (e.g. separation within the secondary circuits) 62368 compliance is not sufficient.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
X Proper Document Control Requests Document Control Systems, Procedures, Forms and Templates 1
S Proper Record/Document Manipulation Document Control Systems, Procedures, Forms and Templates 2
M Proper way to develop LCL when only given a lower spec limit Reliability Analysis - Predictions, Testing and Standards 7
L How to write a proper defect description in a NCR Nonconformance and Corrective Action 4
M Proper method to test flow of a regulator Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Proper terms for describing Hardness General Measurement Device and Calibration Topics 5
M Proper ISO standard for Pressure Testing and Leak Rates Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Proper Thickness Gauge for Foam/Felt and Soft Materials General Measurement Device and Calibration Topics 5
D Proper Tool to Measure Wall Thickness (ISO 3611 - Micrometers) Manufacturing and Related Processes 7
M Proper Gauging - GD&T - Attribute gage to check true positioning on the shop floor Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
I Proper gauging of tight tolerance (reamed) holes General Measurement Device and Calibration Topics 4
kedarg6500 Selection of proper modifying agent for Aluminium Silicon Alloy Manufacturing and Related Processes 2
J Proper Amount of Data Points for Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 12
K Proper YTD PPM Supplier Calculation Six Sigma 3
S Proper FDA Classification for a DICOM Viewer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 29
E Measuring Parts without Proper Tools - Measurement Device Resolution Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
J Proper Method of Measuring Hex Socket Heads Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B Getting the proper information from the supplier - Returning Nonconforming Material Nonconformance and Corrective Action 4
G What is the proper Thanks Giving turkey sampling size? Coffee Break and Water Cooler Discussions 9
B How to Determine the Proper Solder Class Manufacturing and Related Processes 5
S What is the proper flow to feedback the defective found during QA sampling check? Quality Tools, Improvement and Analysis 8
M Proper Format for a Manufacturing Route Sheet Manufacturing and Related Processes 6
K Putting a regulated device on the market without the proper ISO Certs and CE Marking EU Medical Device Regulations 9
L Proper Personnel Ratio - Quality to Manufacturing Manufacturing and Related Processes 6
M ISO14001 nonconformance - no proper treatment of wastewater prior to discharge ISO 14001:2015 Specific Discussions 6
A What is the proper definition for Class 1 & 2 design changes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C Proper GD&T for spindle & housing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Proper term for 'Easy Identification'? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M How to implement a proper Calibration System? General Measurement Device and Calibration Topics 5
F Is there a proper protocol to follow for Self Certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
B True Position without tertiary datum? Establishing a proper rotation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
J Proper way to calibrate a check fixture General Measurement Device and Calibration Topics 7
G Proper Poundage for Checking XX Tolerance Plain Plug Gages? General Measurement Device and Calibration Topics 2
Gert Sorensen Labeling Responsibility - Manufacturer vs. Repacker? Proper Component Use ISO 13485:2016 - Medical Device Quality Management Systems 7
L Procedure for proper use and protection of Registration and Accreditation Marks Document Control Systems, Procedures, Forms and Templates 21
C What is the proper method for cleaning dial calipers? General Measurement Device and Calibration Topics 4
N Proper use of the Blueing process when inspecting the taper of bushings General Measurement Device and Calibration Topics 6
J Proper use of gauge pins - Inspecting thru holes of plastic parts General Measurement Device and Calibration Topics 19
I What is the proper date to use as effective date? Old 'procedures', New documents Document Control Systems, Procedures, Forms and Templates 10
D Rockwell vs. Vickers vs. Knoop - Does Thickness Determine the Proper Test? General Measurement Device and Calibration Topics 1
M What is the proper way to use a GO NO/GO guage? General Measurement Device and Calibration Topics 3
B Preventive and Corrective Action Mapping - Proper Sequencing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Registered or Certified - What is the proper terminology? QS-9000 - American Automotive Manufacturers Standard 17
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Mylar plot suppliers in accordance with D6-51991 document AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
Similar threads
Top Bottom