BS EN ISO 14971:2012, BS EN 62366:2008 and BS EN 15223-1:2012 Questions

Ronen E

Problem Solver
Staff member
Moderator
#11
1. BS EN ISO 14971:2012 (Deviation #3: ALARP vs AFAP)
As far as I understand, AFAP includes everything. The problems begin where you considered a risk acceptable because it was brought to the ALARP level, while it could have been made even lower via implementing means not deemed "reasonable" (in plain English, not economic or not practical).

For new devices, Usability can be addressed in the Design Control SOPs (either through an explicit reference or just as a common practice component). For existing devices, until the new standard issues, I think a well-reasoned RMF could do.

3. BS EN 15223-1:2012
If there's no IFU I'd add the "Do Not Reprocess" text on the device label (if practical; otherwise go to the next packaging level).

Cheers,
Ronen.
 
Elsmar Forum Sponsor

RobertvanBoxtel

Involved In Discussions
#12
Can I share a proposal text that you can use in the IFU, relating to this subject?

? WARNING
Contents supplied STERILE using _____________ [an ethylene oxide (EO) / a Radiation] process. Do not use if sterile barrier is damaged. If damage is found, call your company representative.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
 
R

Ron Boumans

#13
As a representative of a competent authority I can tell you that you are not alone in your struggle with the risk analysis. When I inspect technical documentation I can only work from the essential requirements. I do this with pragmatism:
- Is the description of the intended use well extended?
- Has the intended use been taken in consideration for the risk analysis?
- Has the intended use been incorporated in the clinical evaluation?
- and than I test for a few simple, but often forgotten risks like users that are colour blind, lay users or interruption of power supply ('what if the device is suddenly unplugged?') etcetera

Regarding 'resonably' in terms of risk reduction there are two aspects that I find particularly important:
- The first is that indeed there are practical and economical considerations. Start with the intended use. If this is a well written piece you may have defined that certain situations are to be avoided. There you can do lot to help the practical realization of a safe design, without tripping into the trap of writing all the residual risks away into the manual. The economical aspect is a bit more difficult to tackle, but there I find a proper risk to benefit analyses very usefull. I am not promoting that a manufacturer should calculate the costs of human lives against added manufacturing costs here. All I say is that such a calculation makes it possible to discuss the measures taken. And again, a well written definition of the intended use can be a great help here.
- The second aspect has to do with age of the design. 'Old' designs may have been state of the art a few years ago, but now they are outdated. That means that only by the progression of time a device may suddenly loose its conformity. On the other hand, a well tested - but slightly outdated - device might be safer than a state of the art - brand new - device. This is a situation that has no quick solutions. The best way to avoid problems here, is to understand this is something that can happen to every device at any moment. I would suggest good post market surveillance, combined with a regular update of the clinical evaluation.
 
Thread starter Similar threads Forum Replies Date
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
Q Information for safety EN ISO 14971:2012 - Customer Risk Reduction ISO 14971 - Medical Device Risk Management 6
A Our auditor requires us to attend a training on EN ISO 14971:2012 Other ISO and International Standards and European Regulations 3
W Risk Benefit Analysis - ISO 14971:2012 Requirements ISO 14971 - Medical Device Risk Management 27
B Interpreting Deviations 5 & 6 in Annex ZA in ISO 14971:2012 ISO 14971 - Medical Device Risk Management 1
B Clarification on interpretation of some EN ISO 14971:2012 & IEC 62304:2006 req's ISO 14971 - Medical Device Risk Management 46
F ISO 14971:2012 and the FDA ISO 14971 - Medical Device Risk Management 5
M Labelling and the harmonized EN ISO 14971:2012 ISO 14971 - Medical Device Risk Management 9
F ISO 14971:2012 - 4.3 Initiating Events and Circumstances ISO 14971 - Medical Device Risk Management 4
M ISO 14971:2012 - Verification of Implementation of Risk Control Measures ISO 14971 - Medical Device Risk Management 12
M MDD Europe: Use EN ISO 14971:2012 or ISO 14971:2007 Quality Manager and Management Related Issues 9
J EN ISO 14971:2012 Annex ZA Deviation #4 Clarification ISO 14971 - Medical Device Risk Management 3
J Annex ZA of ISO 14971:2012 - Deviation 7 - Incorrect Interpretation ISO 14971 - Medical Device Risk Management 10
Sam Lazzara Experiences with Notified Bodies addressing EN ISO 14971:2012 Annex Zs ISO 14971 - Medical Device Risk Management 5
K RISK ANALYSIS SAMPLE according to Annex ZA of EN ISO-14971-2012 Other Medical Device and Orthopedic Related Topics 1
R EN ISO 14971:2012 - Implementing Annex Z content deviations ISO 14971 - Medical Device Risk Management 1
rob73 New version BS EN ISO 14971:2012 released - July 2012 ISO 14971 - Medical Device Risk Management 37
M ISO 14971 Determination of Competent Persons ISO 14971 - Medical Device Risk Management 4
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 6
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 8
Bill Hansen New ISO 14971:2019 Harm: unreasonable psychological stress, and cybersecurity ISO 14971 - Medical Device Risk Management 13
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
B ISO 14971 Applied to Software ISO 14971 - Medical Device Risk Management 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
Ronen E Informational What's new in ISO 14971:2019 ISO 14971 - Medical Device Risk Management 2
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
R The difference b/w FMEA & Risk analysis as per iso 14971 ISO 14971 - Medical Device Risk Management 8
D Risk management according to ISO 14971 - When to document risk controls? ISO 14971 - Medical Device Risk Management 10
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
S In a risk analysis, how can we tie mobile app security breach to ISO 14971? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
M Updates to EN 62366 & ISO 14971? Other Medical Device Related Standards 3
D IEC 60601-1 and ISO 14971 Assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
M Example ISO 14971 policy and risk criteria ISO 14971 - Medical Device Risk Management 0
P ISO 13485 and ISO 14971 - one mandates the other? ISO 13485:2016 - Medical Device Quality Management Systems 8
D Rationale for Risk Acceptability Matrix - ISO 14971 ISO 14971 - Medical Device Risk Management 9

Similar threads

Top Bottom