Software in Medical Devices, a blog by MD101 Consulting

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Tag - IEC 60601-1

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Wednesday 23 September 2015

IEC 62366-1 becomes recognized by the FDA

Long time no see. For those of you guys who have been following this blog for a long time.
Today I have time to write a short article on the new version of IEC 62366 standard: IEC 62366-1:2105 Application of usability engineering to medical devices.

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Friday 12 April 2013

MD and IVD standards: IEC 60601-1 and IEC 61010-1, versus IEC 62304 - Part 2

In the previous post, we've seen when it's mandatory to be compliant both with IEC 60601-1 and IEC 62304, and when IEC 60601-1 alone is enough.

But some manufacturers don't apply IEC 60601-1, mainly because their devices are not in contact with the patient or cannot be qualified are medical devices. We find in these categories in-vitro diagnosis instruments and laboratory instruments.
These instruments usually fall in the scope of IEC 61010-1. Let's see now the relationship between IEC 61010-1 and IEC 62304.

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Friday 5 April 2013

MD and IVD standards: IEC 60601-1 and IEC 61010-1, versus IEC 62304 - Part 1

Manufacturers of medical devices often ask themselves the obvious question:
Is it mandatory to be compliant both with IEC 60601-1 and IEC 62304?

Similarly, manufacturers of in vitro diagnosis devices ask themselves:
Are my devices in the scope of IEC 62304?

Obviously, medical devices (MD) with electric or electronic components are in the scope of IEC 60601-1. And in-vitro diagnosis devices (IVD) with electric or electronic components are in the scope of IEC 61010-1.

Do MD and IVD that embed software, fall in the scope of IEC 62304?
This is not so obvious.

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Tuesday 1 November 2011

ISO and IEC standards for software in medical devices in a nutshell

Here is a short description of ISO and IEC standards related to software and medical devices.

The starting point is legal. Government agencies give the authorizations to manufacturers to sell their devices. These agencies rely on standards to ensure that the device was designed and manufactured in a good and safe way. Given these regulations, private companies have to adhere to these standards. Full stop.
Let's see what these standards are.

General standards

Two ISO standards are of high importance for software medical devices: ISO 13485 and ISO 14971. They can be seen as the topmost standards for medical devices. They are very generic and apply to every medical device, from the simplest plaster to the most complex surgeon robot. As they are so generic, they don’t give a clue about software. Other standards do.

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