Transformer Requirements - IEC 60601-1 vs. IEC 61558-2-15

Benjamin Weber

Trusted Information Resource
#1
Dear community,

I am struggling with the following situation: 60601-1, cl. 15.5 has detailed requirements regarding isolating transformers. If a manufacturer decides to use a 61558-2-15 (transformers for supply of medical locations) compliant transformer, will this be OK in all cases? Does 61558-2-15 have requirements regarding patient safety (MOPP), or operator safety only?

It would be great if anybody could give some detailed information on the differences between the requirements of both standards, especially:
- Temperatures
- Short-circuit and overload
- Dielectric strength
- Creepages and clearances

Thanks in advance,
Benjamin
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
G Where to buy Medical Grade Transformer IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
N Triple insulated wire for transformer isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Creepage distance accross insulation of step up transformer EU Medical Device Regulations 2
A MOPs needed after Isolation Transformer IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Transformer Overload Test - Need help IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Transformer Compliance Testing, overheat then humidity treat, then dielectric test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
alonFAI Gaps between the Bobbin and the Ferrite Core in a Transformer Manufacturing and Related Processes 1
R Question on IEC 60601 clause 15.5.1.1 (transformer overheating) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S How to implement protection for multi-winding transformer? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P PSU Transformer Tests Approved to IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
W Supply Voltage Condition for Transformer O/L and S/C (open & short circuit) testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Transformer Oil Analysis - Help with a a Duval's Triangle Preventive Action and Continuous Improvement 3
P Test Voltages for a Pulse Transformer used to Isolate the Patient Connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
L Quality Assurance Manual for Transformer Oils Service Industry Specific Topics 2
E Ethernet Isolation Transformer for Medical Grade PCB IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
S How to overload a linear transformer with multiple protective devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
R How to determine the reference voltage for three-phase transformer? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
G 50 Turn Transformer Coil Calibration Technical question General Measurement Device and Calibration Topics 10
D UL Certified Isolation Transformer Various Other Specifications, Standards, and related Requirements 3
L looking for a forum related to motor/transformer lamination manufacturing Book, Video, Blog and Web Site Reviews and Recommendations 2
G What differentiates a "bridging transformer" from an ordinary "isolation transformer" General Measurement Device and Calibration Topics 5
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 2
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
P Requirements for being an European Representative EU Medical Device Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
lanley liao How to understand correctly the requirements of API monogram products Oil and Gas Industry Standards and Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
J SSQR-01 Vision Requirements- Color Blindness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D LiPo battery minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
S Distributor requirements in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom