CE Marking and use of IEC 80002-1 for Risk Management of Stand Alone Software

M

Mahmood.M

#1
hello to all

I'm new here. I'm glad that I can share my knowledge with you.
Here is a great forum.

now I'm working on the CE marking a standalone software.

We develop a software for ecg analysis. Class B according to IEC 62304
I want to know if IEC 80002-1 can be used for risk management our software or it is for medical products with software (not stand alone).

does anyone have an example of risk management for software?:)


Thank you very much

best regards
 
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bio_subbu

Super Moderator
#2
Re: Use of IEC 80002-1 for Risk Management of Stand Alone Software

hello to all

I'm new here. I'm glad that I can share my knowledge with you.
Here is a great forum.

now I'm working on the CE marking a standalone software.

We develop a software for ecg analysis. Class B according to IEC 62304
I want to know if IEC 80002-1 can be used for risk management our software or it is for medical products with software (not stand alone).

does anyone have an example of risk management for software?:)


Thank you very much

best regards
Hi Welcome to the cove!!!

IEC ISO/TR 80002-1 covers manufacturers risk management and software development when software is part of a medical device or a system and describes how to apply ISO 14971 together with the IEC 62304 standard..
 

Pads38

Trusted Information Resource
#3
Re: Use of IEC 80002-1 for Risk Management of Stand Alone Software

ISO 80002-1 is a guidance document to assist in the use of the main Risk Analysis standard for medical devices which is ISO 14971.

From the introduction to 80002 -
IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device.
 
M

Mahmood.M

#4
Re: Use of IEC 80002-1 for Risk Management of Stand Alone Software

thanks for the answer.

Abstract: This standard says:

IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971so I can use this standard for a stand-alone software . We must also comply with the requirements of the standard 62304

so I can use this standard for a stand-alone software . We must also comply with the requirements of the standard 62304.

I have the following questions on the CE marking of stand alone software :

1. We have a ecg analysis software for presentation of ecg data. The doctor can make a diagnosis with the software and the data from patient can be saved. After our decision , it is a medical device class B (IEC 62304 ) .

There is a big difference in the requirements between the class A and B.
I would like to know your opinion about our classification decision.

2.The following documents must be created in our view for CE marking :

1 Product description with the intended medical purpose
2 Risk management according to ISO 14971 and 80002-1
3.essential requirements
4 list of standards
5.risk classification ( class IIa according to MDD and A or B according to IEC 62304 )
6.clinical evalution

Are the documents complete for CE marking ?

thanks a lot in advance :)
 

Pads38

Trusted Information Resource
#5
In addition to those you have already identified:

1. Administrative Details (Name and Address, Notified Body, Classification)
2. Instructions for Use and Labeling
3. Test Reports (Verification and Validation and other bench testing)
4. Description of methods of manufacture
5. Specifications
6. Production test specifications
7. Description of any accessories involved

You will probably also have to address Usability aspects somewhere.

Best guidance is here-
http://www.imdrf.org/docs/ghtf/fina...ocumentation-ivd-safety-conformity-110317.pdf

GTHF Summary Technical Documentation
 

sagai

Quite Involved in Discussions
#6
Re: Use of IEC 80002-1 for Risk Management of Stand Alone Software

Mahmood,
I think these questions should be clearly addressed by your regulatory-quality guys to be honest.
The way companies addressing CE marking can be different, so it is really up to your company.
Are you from engineering?
Cheers!
 
M

Mahmood.M

#7
@Pads38 : great. Thank you very much.

@sagai:
We are a young and small company (three medical technicians) at the moment. We have not enough experience with the CE Marking. So I ask my question here. We are now building our quality system according to ISO 13485 and we soon bring our first product on the market :)

Cheers!:)
 
M

Mahmood.M

#9
I have two question open:

1. Is the classification the ecg analysis software in the class B (iec 62304), right? our justification: a false doagnose can be occurred by the software. so it may lead to an injury (not serious injury as the class C).

2 what is labeling the software? The requirements of the standard are applicable only in the instructions for use of the software, for example: manufacturer, installer and installation, ist that correct?

thanks
best regards
 

Pads38

Trusted Information Resource
#10
Classification
The choice between B and C will depend upon the exact intended use of the software but you may find a notified Body auditor reluctant to accept Class B unless you have strong rationale to justify Class B.

My thinking is that if it diagnoses atrial fibrillation (say) that failing to spot that (false negative) or diagnosing AF when it is not there (false positive) are both very serious with the consequences including death or serious injury.

Labeling
A few ideas that I have used to label software.

i) Supply on CD with label on the disc
ii) Have a 'splash screen' when the software starts.
iii) Follow the Windows convention and include an 'About' choice on the 'Help' menu - that can show all the necessary info, plus CE mark etc.

It is worth considering what the purpose of the 'Labeling' is. Think of a situation where, in 6 or 7 years time someone is investigating a reported problem with your device or software. They need to easily and unambiguously, identify who made it, where to contact the manufacturer, and exactly what model it is (including for software all the updates and fixes installed). So assume the disc and manual have been lost long ago - they still need to be able to get the information.

It is worth having these requirements in mind whilst you build up your quality system. Can you, several years after you stopped selling it, identify the software and work out the exact configuration of all the items that together form the finished product you supplied?
 
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