FOS (Factor of Safety) Medical Device

  • Thread starter Charlotte Percy
  • Start date
C

Charlotte Percy

Hello All,

I am looking for a published general recommendation for mechanical factor of safety for medical devices. Does anyone have a standard textbook reference?

Thanks,
Charlotte
 

Ronen E

Problem Solver
Moderator
Hi,

I'm not aware of one, such all-encompassing figure.

I doubt that you will find one - "medical devices" is a very broad and diverse field. Almost everything related to medical devices design is risk-based today, so it comes down to what the device is, what it is intended to do and what it can (unintentionally) do, and what the risk is.

Sorry, and I'll be happy if someone will prove me wrong...
Ronen.
 

Ajit Basrur

Leader
Admin
Hello All,

I am looking for a published general recommendation for mechanical factor of safety for medical devices. Does anyone have a standard textbook reference?

Thanks,
Charlotte

Most of the regulations, namely the ones below, state "with an appropriate factor of safety"

Sec. 890.3110 Electric positioning chair.
Sec. 890.3930 Wheelchair elevator
Sec. 890.5150 Powered patient transport

Looks there it will be dependent on design criteria.

Sorry, not able to help but there should be ASTM standards on the related topics.

Please let us know once you get some information. Thanks !
 
C

Charlotte Percy

Thanks Guys,
My Mechanics of Materials professor in college gave us a general rule of thumb of 4 for medical devices. I haven't been able to find any specific number called out anywhere. I guess others don't either.;)
 

Ronen E

Problem Solver
Moderator
Thanks Guys,
My Mechanics of Materials professor in college gave us a general rule of thumb of 4 for medical devices. I haven't been able to find any specific number called out anywhere. I guess others don't either.;)

Could have given you 17, 7 or 2.43 just as well, for that matter. Any rationale for 4?
 
Thread starter Similar threads Forum Replies Date
optomist1 Size Dimension and Feature of Size - FOS as subset of a Size Dimension Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Stoic Which medical device companies are using Recombinant Factor C (rFC) instead of Limulus Amebocyte Lysate (LAL) for endotoxin testing? Sustainability, Green Initiatives and Ecology 0
A Human Factor Validation Human Factors and Ergonomics in Engineering 4
N Must PFMEA Occurrence Factor be Changed Periodically? FMEA and Control Plans 17
P Is the second factor authentication (2FA) required for external users? Qualification and Validation (including 21 CFR Part 11) 1
A One-factor and multiple-response Minitab optimization Using Minitab Software 2
O Problem in Minitab - ERROR * Factor Voltage is highly correlated with other terms Using Minitab Software 10
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Minitab - Factor Analysis: Label on second series of data for Biplot Using Minitab Software 4
S Is Human Factor Testing required as part of Design Control Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Using K-Factor(Tolerance Interval) Analysis for Design Verification Statistical Analysis Tools, Techniques and SPC 3
E IEC 60601-1 Tensile Load Safety Factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E GR&R ANOVA 3rd Factor for Fixture Nests Using Minitab Software 3
N 3 factor - 3 level experiment with DoE and Minitab Using Minitab Software 10
S Human Factor Summative Study Class III Device RA Checklist wanted Human Factors and Ergonomics in Engineering 2
M DOE: Significant factor or not Using Minitab Software 2
F Can be several measurement in a repl considered as nested factor in Minitab analysis Using Minitab Software 14
A Coverage factor in calibration certificate for a multimeter General Measurement Device and Calibration Topics 4
M Taguchi Analysis of Discrete Factor Using Minitab Software 10
N Minimum Design factor for CE Marking for machinery CE Marking (Conformité Européene) / CB Scheme 2
G Setting up a 3 Factor, 2 Level,2 response DOE in Minitab Using Minitab Software 7
Z A DOE in Minitab - 3 factors and 3 levels for each factor Using Minitab Software 12
R How do I extend Correction factor of Calibration cert to compute instrument accuracy Measurement Uncertainty (MU) 1
B DOE Question: 3 factors with 2 levels and 1 factor with 3 levels Six Sigma 2
Z Help with running 3 factor DOE factor optimization Using Minitab Software 2
P Help Setting Up and Analyzing 3 Factor 2 Level Full Factorial Design for DOE Using Minitab Software 3
C 3 Factor DOE (Design of Experiments) Template Document Control Systems, Procedures, Forms and Templates 0
P How to analyze DOE: 2 Factor, 4 Level Experiment Six Sigma 7
J DOE Analysis Experiment, 5 factors, 4 factors having 3 levels, and 1 factor having 5 Using Minitab Software 38
M Multi-factor Anova with Minitab Using Minitab Software 1
K Human Factor Assessment for IRB (Institutional Review Board) Approval? EU Medical Device Regulations 7
I Multiple Comparisons for a Random Factor Using Minitab Software 2
L DOE with 2 factors (3,4 levels) and optimized factor Using Minitab Software 12
P Multi-factor Anova with Minitab Using Minitab Software 11
R What is a Z Value/Factor and where is it most useful? Statistical Analysis Tools, Techniques and SPC 4
T 4 Factor Optimization using Minitab Using Minitab Software 7
I How GUM Uncertainty is calculated and where I locate the multiplication factor b Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
L Filled examples of a Factor Tree (PDCA-FTA) Analysis or a Training Document wanted Problem Solving, Root Cause Fault and Failure Analysis 2
N Test for Equal Variances - Two factor data set - Minitab Using Minitab Software 3
S Surface Finish - Conversion factor to transform Rz Jis in Rz Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
D Influence of the Coverage Factor - Worksheets based on the Average and Range Method Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
T Setting up a Standard Experimental Plan for Food where Factor Levels are Different Statistical Analysis Tools, Techniques and SPC 2
C DoE and ANOVA - 4 factor and 3 levels Taguchi design with 2 replicates Using Minitab Software 14
C Design of Experiments or Factor analysis using existing data Quality Tools, Improvement and Analysis 7
Y Acceptable Fatigue Safety Factor for Testing Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 2
Marc TV Viewing Distance Factor After Work and Weekend Discussion Topics 9
M Control Chart for Dependent obs - One factor for each category weekly Statistical Analysis Tools, Techniques and SPC 7
C What can I treat as an input factor in Minitab? Using Minitab Software 38
R What's the cause of tailing factor in High Performance Liquid Chromatography (HPLC)? General Measurement Device and Calibration Topics 6
P Difference between Fault Tree and Factor Tree Analysis Quality Tools, Improvement and Analysis 1

Similar threads

Top Bottom