Clarification on interpretation of some EN ISO 14971:2012 & IEC 62304:2006 req's

Ronen E

Problem Solver
Staff member
Moderator
#21
However, what Iso 14971 mentions )I don't remember where right now) is that, if the abnormal use is a common medical practice, you should probably identify it as misuse, because everyone uses the device that way...
1. ISO 14971 doesn't mention "abnormal use". Maybe it's discussed under another term (I can't remember now either).

2. That approach doesn't make much sense to me because it undermines the concept of contraindications. Basically what you wrote (or referred to) means that going against a printed contraindication (=abnormal use) should be considered "a use error" simply because that contraindication is absent in other (similar) devices' IFU or simply because a lot of users use that type of device off-label.
 
Last edited:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#22
"Risk-based thinking" does not exist (you really can't find any mention of this in a consistent way in the literature or risk management experience). The "term" was recently created to try to convey an idea that is not really correct.
It would help the discussion if you wrote what exactly is this idea that you claim is not really correct.

I still perceive "risk-based thinking" as a formalisation of (or as you call it, a systematic approach to) survival-induced common sense.
 

Marcelo

Inactive Registered Visitor
#23
1. ISO 14971 doesn'r mention "abnormal use". Maybe it's discussed under another term (I acn't remember now either).
You are right, the term abnormal use was created for IEC 62366 which was created little after the 2007 revision of 14971.

2. That approach doesn't make much sense to me because it undermines the concept of contraindications. Basically what you wrote (or referred to) means that going against a printed contraindication (=abnormal use) should be considered "a use error" simply because that contraindication is absent in other (similar) devices' IFU or simply because a lot of users use that type of device off-label.
What I tried to say is that the design process could have problems, in particular related to device use and user research (as part of a human factors engineering process) and, although the manufacturer deemed the use off-label, it was not in fact off-label, the problem is that the manufacturer did not do a good use research and did not noticed that everyone used the device in a specific way. I've seen this problem happen sometime.

I really do not remember where this is written, maybe in a discussion on IEC 62366 that was not put into the final standard....really do not remember.
 

Marcelo

Inactive Registered Visitor
#24
It would help the discussion if you wrote what exactly is this idea that you claim is not really correct.
I'm not saying it's correct or incorrect, I'm only saying that this "idea" or "term"does not have a historical background. The term used in ISO 9001 has been created from scratch to try too convey a concept, but if you look a the way the term has been used, there's no consistent definition of use of it to mean anything in particular.

I still perceive "risk-based thinking" as a formalisation of (or as you call it, a systematic approach to) survival-induced common sense.
Well, risk management - the formal, historical process - would be a systematic approach to common sense.

"Risk-based thinking", as I mentioned, I don't now what it means.
 
Last edited:

blah01

Involved In Discussions
#25
Hopefully my last question on this...I believe I read somewhere that the US FDA will be "adopting" ISO 14971...I put "adopting" in quotes on purpose because I find it a bit vague, meaning that the QSR already lists ISO 14971 as a reference, but I'm not sure if it will impose ISO 14971 as a requirement. Does anyone have any insights into this?

Thanks.
 

Marcelo

Inactive Registered Visitor
#26
Hopefully my last question on this...I believe I read somewhere that the US FDA will be "adopting" ISO 14971...I put "adopting" in quotes on purpose because I find it a bit vague, meaning that the QSR already lists ISO 14971 as a reference, but I'm not sure if it will impose ISO 14971 as a requirement. Does anyone have any insights into this?
Standards are not mandatory for the FDA. In fact, standards by definition are voluntary, and most countries maintain that status quo. Only some countries (Brazil, China and Korea are the ones I know) require mandatory use of standards.

What happens is that you need to fulfill mandatory regulatory requirements, and standards are usually the best way to show compliance to specific regulatory requirements.

Back to the FDA, the agency has a policy on the use of standards. This link - Standards (Medical Devices) - explains it all (you need to read the guidance linked in this page).
 

Ronen E

Problem Solver
Staff member
Moderator
#27
What I tried to say is that the design process could have problems, in particular related to device use and user research (as part of a human factors engineering process) and, although the manufacturer deemed the use off-label, it was not in fact off-label, the problem is that the manufacturer did not do a good use research and did not noticed that everyone used the device in a specific way. I've seen this problem happen sometime.
I still think that going against an explicit contraindication should be considered abnormal use (provided that there's no practical way to prevent that specific use through actual device design), regardless of what users are commonly doing. It might not be the best design practice, but it's consistent with the definition of the term "abnormal use" as provided in IEC 62366.
 

Ronen E

Problem Solver
Staff member
Moderator
#28
Well, risk management - the formal, historical process - would be a systematic approach to common sense.

"Risk-based thinking", as I mentioned, I don't now what it means.
In my understanding it means applying risk management concepts in whatever you do or think about. The only difference from just applying common sense is that common sense is usually applied informally and sometimes even subconsciously, and risk-based thinking is aimed at making it a concious, formal process (albeit not always fully documented).

That's just my understanding. What the standard authors intended I really do not know.
 
Last edited:

Marcelo

Inactive Registered Visitor
#29
I still think that going against an explicit contraindication should be considered abnormal use
I agree, it's still abnormal use from the standpoint of the application of regulatory requirements regarding label. But depending on the case, I would not consider it consistent with the IEC 62366 definition.

Another example, lets say the device has a control which uses the green colored to identify "stop"and red color to identify "go on". It's implemented on the device this way and described in the instruction for use this way.

But it is not right from the standpoint of human factors because it's not according to human behavior (and established "standards"of color). People will use it incorrectly because of bad design. It's still "abnormal use" from a regulatory standpoint but it's not "beyond any further reasonable means of USER INTERFACE-related RISK CONTROL by the MANUFACTURER".
 

Marcelo

Inactive Registered Visitor
#30
That's just my understanding.
And that's what I'm concerned. Everyone will have it's own interpretation because there's no formal definition and understanding now, and because there's has never been a formal definition and understanding in the past.
 
Thread starter Similar threads Forum Replies Date
A Clarification on the Interpretation of a Few AS9100 Clauses AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
qualprod D5 of 8D clarification, how to verify root cause Problem Solving, Root Cause Fault and Failure Analysis 24
K IPC-610 Section 10.4.2.2 clarification - Distance to be measured Various Other Specifications, Standards, and related Requirements 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification EU Medical Device Regulations 3
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
Q ISO 3310 Clarification Help - Aperture sizes for sieves used for particle sorting Other ISO and International Standards and European Regulations 2
S The Severity of a Medical Device Hazard - Risk Analysis Clarification ISO 14971 - Medical Device Risk Management 6
M 8.3.2.3 Development of products with embedded software - request for clarification IATF 16949 - Automotive Quality Systems Standard 1
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
T Clarification on MDR - Article 18(d) - Implant Card EU Medical Device Regulations 14
S QS, RS deflection - clarification wanted IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S Requirements for Interval Measurement test & Frequency Response test clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Clarification regarding tests in IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Internal Audit clarification - How to perform the audits IATF 16949 - Automotive Quality Systems Standard 6
V Clarification - Hydrogen De-embrittlement Manufacturing and Related Processes 6
K UDI Direct Marking Compliance Date Clarification and one other UDI question Other US Medical Device Regulations 0
N Applied Parts Classification Clarification - Breast Pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Clarification of Injection part shrinkage ratio Manufacturing and Related Processes 1
J ISO 9001:2015 8.2.3 - Review of Requirements (Clarification on compliance) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Health Canada Recall Definition - Seeking Clarification Canada Medical Device Regulations 5
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Clarification of threaded ring gage calibration procedure/requirements General Measurement Device and Calibration Topics 2
M Clarification on Calibration/Verification Records 7.1.5.2.1d (IATF 16949) General Measurement Device and Calibration Topics 11
S AS9102 - Clarification - PO asking for an Assembly at Rev B (Print at Rev C) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Pmarszal Clarification for 21 CFR Part 11.100 - General Requirements Other US Medical Device Regulations 14
B Clarification of ISO 9001:2015 Clause 8.5.6 Control of Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Integrated Phased Processes - AS9100D cl. 8.1 Operational Planning - Clarification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Monitoring and Measuring Resources (7.1.5) - Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
dubrizo Clarification Requested in 6.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F TS 16949 Clause 7.2.1 - Note 2 - Recycling program - Clarification IATF 16949 - Automotive Quality Systems Standard 4
K EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols Other Medical Device Related Standards 3
S Clarification regarding types of processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Clarification of Applicability of TS 16949 Requirements to a Non-Automotive Business IATF 16949 - Automotive Quality Systems Standard 13
M Request for clarification on TS 16949 Clause 5.6.1.1 IATF 16949 - Automotive Quality Systems Standard 5
Q Configuration management clarification and example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Clarification in organizing required documents for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 6
J Definition Actively Manufacturing - ISO 13485 Definition and clarification Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
T Early Research & Development - ISO 13485:2003 requirements Clarification ISO 13485:2016 - Medical Device Quality Management Systems 34
B Detachable Power Supply Cable Connection ESD Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D NIST HDBK 44 Table T.3. Class III Tolerance in Divisions Clarification General Measurement Device and Calibration Topics 4
M UDI - Direct Marking and Reprocessing Clarification Other US Medical Device Regulations 12
S 21 CFR Part 820.40(b) Clarification on Required Document Approvers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Clarification on Document Signatories under ISO9001 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P ISO 27001:2013 Clause 4.1 and 4.2 Clarification and Guidance IEC 27001 - Information Security Management Systems (ISMS) 13
C Positional Tolerance - Bonus / Datum Shift / ASME Y14.5M - Clarification Various Other Specifications, Standards, and related Requirements 9
K Free from any Undue Internal and External Pressures - 4.1.5b clarification General Measurement Device and Calibration Topics 2

Similar threads

Top Bottom