ISO 14971:2007 Risk Management - Class I A Sterile Medical Device

medwise

Involved In Discussions
#1
Dear all,

This is my first thread and I would really appreciate your help.I am very new to my job and have no experience apart from university and my internship.

In my new job I have been told to do the risk management of a medical device. The device is class I A sterile and is used for laproscopic surguries especially hysterctomy.

After reviewing the technical file I realised that since this document was produced another version of ISO14971 has been published which is in 2007. While reading that I saw significant differences between the old and the new one. In the new risk management document which I am working on I have included Potential Hazards, Foreseeable Sequences of Events, Hazardous Situations, Harm, Impact and Likelihood, Risk Rating as part of my risk assessment.

So the query is do I have to describe or mention causes of potential hazards as well or causes are considered as the part of foreseeable sequences of events? And I would also like to gain your views regarding the types of potential hazards apart from energy, bio hazards, chemical, operational and informational hazards.

Thank you,
Regards

Romit Singh:)
 
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Marcelo

Inactive Registered Visitor
#2
Re: ISO 14971:2007 Risk Management

So the query is do I have to describe or mention causes of potential hazards as well or causes are considered as the part of foreseeable sequences of events?
I´m not sure i understood your question, could you give some example? Are you talking root cause here?

Generally, the cause is included in the sequence of events because, as you describe what happened (or can pottentially happen), one or more of the steps are done wrong (fault) which led to the harm. This is not always true because there´s really no need to a fault (you can do everything ok and still produce harm). This shows that the "root cause" is not always clear and may need more study to be defined.

Also, it´s always better to act on the root cause to prevent the problem, but this is not always feasible.

And I would also like to gain your views regarding the types of potential hazards apart from energy, bio hazards, chemical, operational and informational hazards.
The ones you cited are the "general" detailed hazards used in table E.1. This example taxonomy was created to have a lot of sub-hazards as shown in the table, but are not exhaustive. Anyway, i would not advise on expanding this too much because you can easily get lost - for example, some hazards might fit into more than one category - usability is and example - and in this case the root cause might be needed for the correct classification (is this the reason why you´re asking about the "cause?)

There´s lot of source of possible ramifications of this hazard list. Some are:

- list of essential requirements (MDD annex I, GHTF) - a lot of examples.

- product requirements - it might be interesting to use the taxonomy of product requirements in conjunction with the hazard requirements. This would facilitate the reporting of adverse events and the linking of the problems with the design requirements. An example of these can bee seen, for example, in ISO/TS 19218:2005 - Medical devices -- Coding structure for adverse event type and cause (which is in revisions at the moment).
 

sagai

Quite Involved in Discussions
#3
Yes, MDD Annex I is really great start to create a list of hazards, but also not to forget to check each Articles if there is a relevant one to your device.
And not to forget to use the corresponding MDD according to your device :lol:
When you have a list add detailed about:
- Hazard Category
- Hazardous situation description
- Potential effect/harm
- Severity, frequency, probability, acceptability before risk control
- Risk mitigation
- Severity, frequency, probability, acceptability after applying risk control
- Rational
- Risk Control traceability

Yes, not as simple as you might thought but not rocket science for sure.
And not to forget to supply your risk management with corresponding SOPs.

I have a draft template for IDV Class II devices if you need, but I am not sure this one the thing u need.

hi
Sz.
 
J

jeszar

#4
Dear all,

This is my first thread and I would really appreciate your help.I am very new to my job and have no experience apart from university and my internship.

In my new job I have been told to do the risk management of a medical device. The device is class I A sterile and is used for laproscopic surguries especially hysterctomy.

After reviewing the technical file I realised that since this document was produced another version of ISO14971 has been published which is in 2007. While reading that I saw significant differences between the old and the new one. In the new risk management document which I am working on I have included Potential Hazards, Foreseeable Sequences of Events, Hazardous Situations, Harm, Impact and Likelihood, Risk Rating as part of my risk assessment.

So the query is do I have to describe or mention causes of potential hazards as well or causes are considered as the part of foreseeable sequences of events? And I would also like to gain your views regarding the types of potential hazards apart from energy, bio hazards, chemical, operational and informational hazards.

Thank you,
Regards

Romit Singh:)
There is a new standard in Europe: EN ISO 14971: 2009, but it is exactly the same. Open the attached file. It is in Sapnish, but is easy to understand

Regards, Jeszar
 

Attachments

Thread starter Similar threads Forum Replies Date
M ISO 14971:2007 Revision Approved - The Delft ISO TC 210 plenary meeting - Nov 2016 ISO 14971 - Medical Device Risk Management 2
M The future of ISO 14971:2007 ISO 14971 - Medical Device Risk Management 2
M MDD Europe: Use EN ISO 14971:2012 or ISO 14971:2007 Quality Manager and Management Related Issues 9
M Risk Management (ISO 14971:2007) Internal Audit Checklist ISO 14971 - Medical Device Risk Management 7
N ISO 14971:2007 vs. 2009 - Which Risk Management Standard is still accepted in the EU Other ISO and International Standards and European Regulations 2
M Risk Management Plan Template - ISO 14971:2007 Compliant ISO 14971 - Medical Device Risk Management 13
B Is ISO 14971:2007 still a valid standard? ISO 14971 - Medical Device Risk Management 9
D ISO 14971:2007 training wanted in or near the Netherlands ISO 14971 - Medical Device Risk Management 5
G Risk Analysis - Templates of EN ISO 14971:2007 and others ISO 14971 - Medical Device Risk Management 8
G Cl 4.2, ISO 14971:2007 - Intended use & identification of characteristics related... ISO 14971 - Medical Device Risk Management 1
D BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007 ISO 14971 - Medical Device Risk Management 37
V ISO 14971:2007 Application of Risk Management to Medical Devices ISO 14971 - Medical Device Risk Management 9
Q Risk Analysis of Software - ISO 14971:2007 ISO 14971 - Medical Device Risk Management 29
C Does ISO 14971:2007 (E) apply to software? ISO 14971 - Medical Device Risk Management 18
C What does the revision letter stand for in ISO 14971:2007(E) ISO 14971 - Medical Device Risk Management 11
V ISO 14971: 2007 Risk Management File - Separate file required for each product? ISO 14971 - Medical Device Risk Management 3
N What is the necessary implementation date for ISO 14971:2007 ISO 14971 - Medical Device Risk Management 2
N ISO 14971:2003 vs. 14971:2007 - Major differences ISO 14971 - Medical Device Risk Management 5
J Overall Residual Risk Procedure based on the 2007 version of ISO 14971 ISO 14971 - Medical Device Risk Management 4
S Life Cycle - ISO 14971:2007 meets ISO 14630:08 ISO 14971 - Medical Device Risk Management 5
R Medical Device Software Risk Management and ISO 14971:2007 ISO 14971 - Medical Device Risk Management 7
B When should the medical device industry show compliance to EN ISO 14971(2007) ISO 14971 - Medical Device Risk Management 8
W Application of Risk Management - ISO 14971:2007(E) Medical Devices ISO 14971 - Medical Device Risk Management 69
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
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
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
Q Information for safety EN ISO 14971:2012 - Customer Risk Reduction ISO 14971 - Medical Device Risk Management 6

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