Dear folks,

I am a new user and I am glad to be part of this major forum.
I had a few questions concerning ISO norms.
I'm working at a firm that makes cochlear implants.

1. I have to build the requirements for the hardware but I can't find any norm that explains that. For software it is easy, it is norm 62304, but is there something for hardware also?

2. How can I make a perfect treacebility for system requirements (toplevel of the medical device) and the hardware system requirements (the parts of the toplevel, a part makes another part), so we have a bunch of hardware system req of a part, that gets divided in other parts with also hardware system requirements. How can I make a full treacebility of my hardware system.

3. In ISO-norm 'risk management medical devices' 14971 is there in the appendix F, explaining FMEA, a risk analysis technique. Does somebody have the ISO-norm IEC 60812 for the development of this FMEA?

Thank you all in advance.

Kind regards,

Ugurovic

Hi Ugurovic,

Welcome to the cove :bigwave:

You will to have wait to get response - any takers ? :)

Thank for your reply.

I'm waiting a long time to get answers :-)

But I'll be waiting a lot more, it's no problem.

Kind regards.

Ugurovic

Appreciate your patience - sometimes the right persons are away and may require slightly longer time. The general type of questions may be responded quickly while some specialized questions may take longer time.
:)

Dear folks,

I am a new user and I am glad to be part of this major forum.
I had a few questions concerning ISO norms.
I'm working at a firm that makes cochlear implants.

1. I have to build the requirements for the hardware but I can't find any norm that explains that. For software it is easy, it is norm 62304, but is there something for hardware also?

2. How can I make a perfect treacebility for system requirements (toplevel of the medical device) and the hardware system requirements (the parts of the toplevel, a part makes another part), so we have a bunch of hardware system req of a part, that gets divided in other parts with also hardware system requirements. How can I make a full treacebility of my hardware system.

3. In ISO-norm 'risk management medical devices' 14971 is there in the appendix F, explaining FMEA, a risk analysis technique. Does somebody have the ISO-norm IEC 60812 for the development of this FMEA?

Thank you all in advance.

Kind regards,

Ugurovic

To answer on 1. :

maybe there is something for you in :
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=29682
or
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=38147
or
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=41275

Some more stuff can be found in that neighbourhood.

Success and best regards,

Antoine

1. I have to build the requirements for the hardware but I can't find any norm that explains that. For software it is easy, it is norm 62304, but is there something for hardware also?

There´s no standard that explain that. Safety standards only deal with the risk control part of the design (this means that each "requirement" - do not confuse with the device design requirement - from a safety standard is a risk control measure option as defined in ISO 14971, and the compliance tests are the means to verify the implementation and effectiveness of the risk control measures). These are usually derived from requirements, but are not the requirements themselves (but you can use the information to create requirements, meaning, if you define the hazard situation that the "safety standard requirement" tries to control, you can deduce the original requirement for the device. Just remember that it´s not always obvious.

Also, if you think that IEC 62304 defines requirements for software, you´re again misunderstanding the concept of standards and legislation. Standards and legislations (including processes standards as IEC 62304 and system standards as ISO 13485 and ISO 14971) are only concerned with the "control" portion of the design lifecycle, meaning, you have to have a design process of your own, and use the standard to control some aspects (you could also be brilliant and not need any standard and legislation because your design process has enough control, but i doubt that). In this way, IEC 62304 is nothing more than guidelines for a development lifecycle. It in fact has no requirements for a real software, it only has requirements for control of the software design process.

2. How can I make a perfect treacebility for system requirements (toplevel of the medical device) and the hardware system requirements (the parts of the toplevel, a part makes another part), so we have a bunch of hardware system req of a part, that gets divided in other parts with also hardware system requirements. How can I make a full treacebility of my hardware system.

You need to implement a requirements engineering process that controls all requirements related to the device in the device lifecycle. Suggest reading a requirements engineering book such as The Requirements Engineering Handbook from Ralph Young (take a look at some examples in his website to understand what i´m saying http://www.ralphyoung.net/artifacts.html). What you´re talking about dividing requirements is what is called requirements decomposition, and is in fact usually related to reliability requirements in what is known as reliability decomposition or reliability block diagram (you DO have reliability requirements in the reliability program of your device, don´t you? :-)). So you could also take a look at some reliability information such as Medical Device Reliability and Associated Areas by B.S. Dhillon or the second part of the book Practical Design Control Implementation for Medical Devices by jose Justiniano (also any book or paper from Richard Fries is a must as he is a medical device reliability expert).

3. In ISO-norm 'risk management medical devices' 14971 is there in the appendix F, explaining FMEA, a risk analysis technique. Does somebody have the ISO-norm IEC 60812 for the development of this FMEA?

I have the standard, but i would really advise you on buying a book on the topic.

Thanks for your answers fellas.

I'll take a good look at it and read the information you gave me.

This is a really really nice forum!!!

Kind regards

Ugurovic

Hey guys,

Could someone post a lifecycle process for the development of the hardware and say to wath standards is referred to? I'm using the
hardware section of the GAMP (good automated manufacturing systems)
and I would like to see other ones too.

Thanks MMANTUNES and ANTOINE.DIAS, you're answers were great!!!

Kind regards

Ugurovic