Fuse Agency Approvals - Fuses without VDE / IEC Approvals on AC Mains Lines

phase90

Involved In Discussions
For devices sold into Europe, is it acceptable to use fuses on AC Mains lines that have UL agency approval , but not VDE / IEC approvals?
 

Peter Selvey

Leader
Super Moderator
For the practical side, you need to check the details of the UL approvals fit with the situation. For example, for a mains fuse, you typically need 1500A breaking capacity. Some UL fuses are tested to 10,000A breaking capacity (which is fine), but the test is done at 100V, not 230V found in Europe. I would not use the UL fuse in this situation. Consider a fire caused by your device, fuse did not work or exploded. UL will walk away and say it's not our fault, the fuse was used outside of specification.

On the technical side, IEC 60601-1 requires IEC standards to be used (for parts related to MOP, which fuses are often considered). So, if a part only meets a UL standard (or any non-IEC standard), it should be written up in the risk management file as a alternate solution. This has been a common approach if IEC certified parts not yet freely available (batteries, PCBs).

But for fuses, it could be trouble as IEC certified fuses have been around for a long time.
 

phase90

Involved In Discussions
Thanks for the quick response, Peter.
I agree with you on the breaking capacity. In this case, however, the fuse is a high breaking capacity and has breaking capacity ratings for both 125VAC and 250VAC (as well as 500 VAC, 63 VDC, and 400 VDC). It just does not have a VDE listing on the datasheet. I suspect it is because it is a 3AB (6.3 x 32 mm) rather than a 5 x 20 mm.
 
Thread starter Similar threads Forum Replies Date
V Functional safety for Fuses and Fuse boxes ISO 26262 - Road vehicles – Functional safety 0
L DC Powered Medical Device Fuse / 15.4.3.5 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
L Allowable AC mains fuse types for latest IEC60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Spacing between the solder eyes of the fuse input/output leads IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
J Determining Fuse Rating and Labeling - Medical Device Crash Cart IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S About the rating of fuse - Can I employ 2 fuses of different rating in my equipment? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
B Qualifcations of Staffing Agency Employees to meet job description General Auditing Discussions 6
M Informational From RAPS – Danish Medicines Agency Ramps Up Capacity in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Statement on agency’s efforts to increase transparency in medical device reporting Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device Medical Device and FDA Regulations and Standards News 0
M Medical Device News FDA news - 17-09-18 - Agency's commitment to studying breast implant safety Other US Medical Device Regulations 0
M AS9102 Training - Seeking third party agency that provides online AS9102 training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
JoCam Incident Reporting MHRA (Medical & healthcare regulatory agency) EU Medical Device Regulations 3
A QMS (Quality Management System) for Logistic Agency ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C DCMA (Defense Contract Management Agency) asking for Inspection Schedule Dates AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
W Medical Agency Label - A handshake, USA, printed over a US flag ISO 13485:2016 - Medical Device Quality Management Systems 1
E External Training - EMEA (European Medicines Agency) Regulations Training - Internal, External, Online and Distance Learning 1
P Testing Standards - Regulatory agency doing Enforcement Testing of Medical Devices EU Medical Device Regulations 5
M MHRA (Medical & Healthcare Regulatory Agency) Design Dossier Review Delays EU Medical Device Regulations 2
T CFIA (Canadian Food Inspection Agency) Letter of Non Objection Food Safety - ISO 22000, HACCP (21 CFR 120) 2
E Lean in a Government Agency! Lean in Manufacturing and Service Industries 3
A Supplier Evaluation Procedure in case of Agency (Distributors) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
bio_subbu European Medicines Agency Seeks Comments on Drug/device Consultation Process EU Medical Device Regulations 0
R ISO 9001 Internal Quality Audit by Consultants (External agency) Internal Auditing 5
Q EASA (European Aviation Safety Agency) Form #9 Check List Federal Aviation Administration (FAA) Standards and Requirements 9
G New SVHC's - The European Chemicals Agency (ECHA) June 18 added eight substances RoHS, REACH, ELV, IMDS and Restricted Substances 0
S EASA (European Aviation Safety Agency) Approval for Auditors EASA and JAA Aviation Standards and Requirements 3
G ISO 9001 Implementation in a Travel Agency ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Marc EASA (European Aviation Safety Agency) EASA and JAA Aviation Standards and Requirements 3
F EASA (European Aviation Safety Agency) DOA: Which category? EASA and JAA Aviation Standards and Requirements 4
Le Chiffre Obtaining a "Small Business Waiver" for FDA from Canada Revenue Agency US Food and Drug Administration (FDA) 2
D What knowledge should supplier and buyers of computers (public service agency) share? Supplier Quality Assurance and other Supplier Issues 1
C Drug Registration in European Union - European Medicines Agency (EMEA) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
C What is EASA (European Aviation Safety Agency) Part 21 G EASA and JAA Aviation Standards and Requirements 2
J Off the shelf design - Web & Graphic design agency Design and Development of Products and Processes 3
T Is it possible to turn down compensation offer? Staffing Agency issue Career and Occupation Discussions 11
D What are the core processes in a public service agency? Service Industry Specific Topics 4
M EASA (European Aviation Safety Agency) Part 21 Subpart G EASA and JAA Aviation Standards and Requirements 5
D Examples of Non-conforming Service for a Recruitment Agency Nonconformance and Corrective Action 6
P Corrective action against the auditing agency? Written contract is in error AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
T How to Apply ISO 9001 in Government Agency or Administrative Organizations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
E Share experiences using a contract agency to perform source inspection Misc. Quality Assurance and Business Systems Related Topics 5
C Where is the highest IMTE calibrating agency? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Incorporating green purchasing into federal agency environmental management systems Sustainability, Green Initiatives and Ecology 2
B Environmental Aspects for a Federal Agency Miscellaneous Environmental Standards and EMS Related Discussions 7
K Compelling reasons for a certifying agency to withdraw a ISO certificate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B CCCF - China Approval Agency - Difference of Opinion Various Other Specifications, Standards, and related Requirements 9
V Certification Agency (Company) for BS 15000 - Now ISO 20000 IT (Information Technology) Service Management 18

Similar threads

Top Bottom