Can a Surge test fail to a test level and still considered as Compliant?

J

joshidileep

#1
Dear all,
Can anyone help me in understanding a situation cited below:
During our 60601-1-2 testing, Surge test failed at 2KV and the System shut down. However by risk assessment it was concluded that as the system shut off (failed safe), Basic safety was not compromised and did not hamper the essential performance, it was decided to consider surge failure as not a failure and still compliant to Surge test requirement.
my query is:
1. Is it acceptable
2. Do we need to inform this to the end user of the system. and if yes how?

Thanks with regards
Dileep Joshi
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
I personally can't help, but here is a quick "Bump" - My Thanks in advance to anyone who can help with this one.
 
H

hcrook

#3
1) This is acceptable if you're not saying that system shall withstand 2kV surge (line to ground?), which is what it sounds like you've concluded based on your risk management.

If the system has been designed to pass 2kV surge and you have that as a traceable requirement, even though Basic Safety wasn't affected Essential Performance would be and I don't think this would be compliant in that case.

2) This should be addressed in your Intended Use documentation.
 
#4
This is rather dependant upon how you have classified your Essential Performance.

The Compliance Criteria, at 6.2.1.10, state that 'resets' and 'cessation of intended operation' shall not be allowed.

But that applies only if they are associated with Essential Performance - you would have to argue that your device has no Essential Performance (not catching fire is considered Basic Safety!).

Regulators and test houses are usually very reluctant to allow the "no Essential Performance" argument - they would suggest that a medical device with no Essential Performance has no medical purpose, so is not a medical device!

If you have some inherent sensitivity to surge you might be able to use the justification set out in 6.2.1.1
Lower IMMUNITY COMPLIANCE LEVELS are allowed provided they are justified based on significant physical, technological or physiological limitations.
Look to the part 2 Particular Standards for guidance on this allowance.

In such a case I would expect to see prominent warnings within the Operators Manual and Risk Management would have to carefully take this into account, along with probabilities that the device would only be connected to 'low-surge' mains supplies (perhaps you, as manufacturer, supervise the installation process and supplies are only ever dedicated supplies fed from local hospital sub-stations).

Or you could add some extra surge protection!

(Clause numbering is from the 2007 version).
 
Last edited:
Thread starter Similar threads Forum Replies Date
J Surge Protectors and other power protection Manufacturing and Related Processes 7
Sidney Vianna What do these things have in common? Surge in new ISO Committees & Standards Other ISO and International Standards and European Regulations 7
B Surge Marks in Coextrusion Process Manufacturing and Related Processes 2
Q Standard Home Surge Protector Testing Requirements Reliability Analysis - Predictions, Testing and Standards 3
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 5
C DV/PV Test Part Storage IATF 16949 - Automotive Quality Systems Standard 1
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
Vader22 5 Why RCA for failure to test Contingency Plan IATF 16949 - Automotive Quality Systems Standard 9
S Knee-Patella wear test CE Marking (Conformité Européene) / CB Scheme 4
L PFMEA for test procedures (ISO 14971) ISO 14971 - Medical Device Risk Management 5
A Direct vs. Post-License Investigational Test Authorization (ITA) Canada Medical Device Regulations 0
P Test Method Validation (TMV) for all Measurement Methods in Rec/Inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
L AS9100 Section 8.4.2 - External provider test reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
E How to test 8.7.4.7 d) ? What "not protectively earthed accessible part" means? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T ANOVA analysis to find F test. Using Minitab Software 3
P API Q1 - Monogram Product & API 4F - Proof Load Test Oil and Gas Industry Standards and Regulations 3
D Test Management Software Software Quality Assurance 1
B How to test operator to see if they can catch the defective parts? Manufacturing and Related Processes 6
G 60601-1 8.8.3. short circuit of both side during insulation test IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Bacterial Endotoxin test for Purified water Manufacturing and Related Processes 2
shimonv Test Method Validation ISO 13485:2016 - Medical Device Quality Management Systems 10
C Test compulsory for Sutures? Manufacturing and Related Processes 6
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
K Identification test in ph.eur. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
AllTheThings ISO-17025 accredited TEST lab performing internal calibrations (Yes: Here is how) ISO 17025 related Discussions 6
R Cost per test tool/formula Oil and Gas Industry Standards and Regulations 1
R Cost per test tool/formula Oil and Gas Industry Standards and Regulations 1
A R chart from ANOVA gage R&R test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Burst Test Acceptability Criteria ISO 13485:2016 - Medical Device Quality Management Systems 2
A 60601-1 clause 8.11.3.6 Test Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
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 1
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
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

Similar threads

Top Bottom