Property - What is defined as Property in ISO 14971

R

RAlille1400

#1
Dear all,

a new wondering...

the word "property" is regularly used throughout the english text of EN 14971:2012, for example :

harm is defined as : "
physical injury or damage to the health of people, or damage to property or the environment"
"A hazardous situation occurs when people, property or the environment are exposed to a hazard"... etc

What is really defined as property ? in the French text of this harmonised standard, 'property' is translated as "Goods" ('Biens' in French).
Shall we consider that property covers intellectual property of a devices ? Is it related to the personnal patients goods that could be damaged ?

When prforming the risk analysis, shall we consider that this 'property' supports any functional part of the concerned device ?


May i ask for your opinions on that wording issue ?
kind regards,
RA.


 
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Marcelo

Inactive Registered Visitor
#2
Re: Propery in 14971

This comes in fact from the general IEC and ISO definition of harm from ISO IEC Guide 51. It was created to be applicable for all standards created by ISO and IEC.

In the case of the medical devices field, the real problem is harm to people, with a focus on patient and user.

Generally, the only consideration for property and environment is if a problem to them creates a problem to people.
 
#3
Re: Property in ISO 14971

After checking several (English) dictionaries for a suitable definitive meaning I would suggest it is not used very clearly.

Does it refer to Property - as in a building?

Does it refer to Property - as to imply ownership of an object? and if so who's ownership?

I would suggest that it could be the second meaning and can refer to any object, owned by any person or institution involved.

eg
A patient's clothing is damaged by a faulty hoist.

A clinicians clothing is similarly damaged.

A hospital's building is damaged by the faulty hoist.
 

Marcelo

Inactive Registered Visitor
#4
Re: Property in ISO 14971

A patient's clothing is damaged by a faulty hoist.

A clinicians clothing is similarly damaged.

A hospital's building is damaged by the faulty hoist.
Unless it leads to harm to a person, this kind of property damage it not a problem to the medical device regulations in general.

So, the manufacturer would not be expected to analyze this.
 
R

RAlille1400

#5
Re: Property in ISO 14971 - What is defined as Property

Thanks both of you.

I also agree that we could only consider properties/goods damages that lead to a people (patient/user) harm.
I agree with Marcelo, the kind of property that could be damaged is not so important unless patient/user is still safe.
I also agree with Pads38 (thank for taking time to check dictionnaries!) the second meaning is much appropriate....

the implicit question was : Practically, do you consider that 'property' point when reviewing your risk analysis ? shall we take it in account... this was know ansewered. unless anyone said the contrary... LoL :D
Thx again.
 
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