SBS - The best value in QMS software

CPU BIST IEC 62304 - Embedded code has CPU instruction tests

W

WeightOnWheels

#1
Hello all, my first post but I've been poking around for a while. Great spot for excellent information.

I've been performing IV&V within different safety critical industries for a few years now. I have a new medical device project and I noticed that the embedded code has CPU instruction tests that are executed every time the system is powered up. My question is, Is this completely necessary? I ask because this is a class C device and I'm wondering if this can just get removed by the developers, or if it is in fact needed, will we have to perform complete tests (unit tests, integration..) on these instruction tests?

I've never seen these types of tests done at every startup. I've seen ram tests but not built in opcode testing.

Please advise.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Re: CPU BIST IEC62304

Anything implemented should tie back to a requirement (which could be a risk control). I'd get the developers to walk it back to requirements. Since it's class C, there should be a pretty good trail back up through detailed design & architecture.
 
W

WeightOnWheels

#3
Re: CPU BIST IEC62304

Thanks yodon!
Since this is a really big job, I just wanted to make sure it was completely necessary. Or if I could just yank it out. The code for these tests create an incredible amount of code that now has to be verified down to the unit test level.

Thanks again!
 
Thread starter Similar threads Forum Replies Date
S Process Capability questions - Calculating Cpu using Minitab Six Sigma 6
O Cpu & Cpk can be calculated the same? Capability, Accuracy and Stability - Processes, Machines, etc. 1
O Intermediary calculations for Cpk - What do CPU and CPL stand for? Statistical Analysis Tools, Techniques and SPC 5
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
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
S IEC 60601-2-30 - Is it mandatory to claim alarms? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
R IEC 60601-1 - Power Supply Cords (Section 8.11.3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Complex IEC 60601-1 gap assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
S IEC 62304 software costs and time Medical Device and FDA Regulations and Standards News 3
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
R Hand transmitted vibration 9.6.3 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 62471 vs IEC/TR 62778 CE Marking (Conformité Européene) / CB Scheme 0
B IEC 61010, Touch currents related to burns at higher frequencies (cl. 6.3, A.3) Other Medical Device Related Standards 0
M IEC 61000-4-2: Requirements for coating declared as insulating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Who is the customer in the ISO/IEC 17025:2017? ISO 17025 related Discussions 1
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
B IEC 61010-1 - Voltage / Dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M When is EN 62133-1 (new version i.e. IEC 62133:2017) mandatory in EU Other ISO and International Standards and European Regulations 0

Similar threads

Top Bottom