Are ISO 13485 & ISO 14971 applicable to Healthcare IT software?

[KuttyPapa]

Dear Friends,

I would like to Know whether ISO 13485,ISO 14971 & ISO/IEC 20000 is applicable to healthcare IT software.
If it is applicable then kindly Justify me and also justify me if it is not applicable.

Kind Regards,
J.R. Vijeyachander

 

[somashekar]

Re: ISO 13485 & ISO 14971

Dear Friends,

I would like to Know whether ISO 13485 & ISO 14971 is applicable to healthcare IT software.
If it is applicable then kindly Justify me and also justify me if it is not applicable.

Kind Regards,
J.R. Vijeyachander

Welcome to the Elsmar Cove J.R. Vijeyachander ~~~~~

Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, can be a medical device...

Is your Healthcare IT software intended by you to be used, alone or in combination,
for human beings for one or more of the specific purpose(s) of
 diagnosis, prevention, monitoring, treatment or alleviation of disease,
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
 investigation, replacement, modification, or support of the anatomy or of a physiological process,
 supporting or sustaining life,
 control of conception,
 disinfection of medical devices,
 providing information for medical purposes by means of in vitro examination of specimens derived from the human body, ....
If yes, then it is a medical device and so ISO13485 is applicable with your YES for justification for the above definition taken from ISO13485.

Further when you agree that your product is a medical device then ISO14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

So ISO14971 ia applicable and stands justified.

Italic bold are referenced form the ISO13485 standard and the Abstract about ISO14971:2007 from www.iso.org

 

[KuttyPapa]

Dear ALL,
Thanks lot for you information. I would like to know more about ISO 13485, ISO 14971 & ISO/IEC 20000.
Let us assume that am into real-time, on-line, integrated information management system for hospitals, addressing all critical areas of health care activity. Kindly brief me whether ISO 13485, ISO 14971 & ISO/IEC 20000 are applicable here , If so in what way all these standards are useful.

Thanking You in Advance,
kind Regards,
J.R. Vijeyachander

 

[phloQS]

Hi and welcome to the cove,

ISO 13485 is a standard for quality management systems and never applicable directly on devices. A QMS should be installed in companies which produce e.g. medical software. ISO 14971 describes a risk management process which should be applied while producing medical devices (in combination with ISO 13485).
If your software is a medical device under MDD 93/42 than you as the producer can install such managment system/process to show compliance with the directive and to use the CE- Mark. There are many other applicable standards for software as a medical device: ISO62304, IEC 60601-1-4 and others. If you are completly new in the field of medical devices, I would recomend to choose a good consultant who can help you to find a way trough the field of highly regulated medical devices.

regards

phloQS