All,
Realize IEC 60601-1, ed. 3.0 or 3.1 requires a process under ISO 14971, per
sub-clause 4.2.2, so doesn’t matter what you think you need.
Here is the first sentence of 4.2.2 “A RISK MANAGEMENT PROCESS complying with
ISO 14971 shall be performed"
So, sorry but ISO 14971 MEDICAL DEVICE risk
“… does a palliative involve an interchange of energy?
Yes, chemical energy. But, no injury.
Rich
-
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message
I knew someone would come back with that reply.
Technically, it may or may not be correct (does a palliative involve an
interchange of energy?) but in practice it stretches the original assertion
beyond any useful application.
As ever, real life is more complex than it is possible to express
“Injuries to a living organism can be produced only by some energy interchange.”
Not all risk are of energetic nature:
Risk is never a function of energy interchange. Risk is the “combination of
the probability of occurrence of harm and the severity of that harm.”
Injury is a function of
Life is consist of risk assessments!
If you cross a road, you quickly assess the risk of safely getting to
the other side.
What you call a scientific method, is a risk assessment based on
physical hypotheses , but the hypothesis might be wrong tomorrow, or in
another place. But the chance of
If the device transfers energy, but the energy proves ineffective, that
is still an 'energy interchange'. If the device fails to transfer
energy, there is no 'cause' to produce an 'effect', so any injury is not
due to the device but to some other energy interchange.
Do we rename the list 'IEE
In the medical device context, no this is not correct because the failure of
the device to provide the claimed medical benefit can be a cause of ‘injury’.
Nick.
> On 17 Apr 2018, at 20:17, Richard Nute wrote:
>
>
>
> Do you agree or disagree with James Gibson’s assertion that
>
> “In
“… well understood risk management process provides a quite scientific and
systematic method for identification of safety related issues in the
construction…”
I don’t agree that the risk management process “provides a scientific… method…”
ISO 14971 requires identification of the ha
Thanks for the explanations. However, I still think that at some point
risk assessment is inevitable.
John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK
On 2018-04-17 00:22, Richard Nute wrote:
… how do you test *objectively* the adequacy of a s
Nick,
I would like to highlight the following text from IEC 60601:
"7.9.2.3 ME EQUIPMENT specified for connection to a separate power supply
If ME EQUIPMENT is intended for connection to a separate power supply,
either the power supply shall be specified as part of the ME EQUIPMENT or
the combinat
… how do you test objectively the adequacy of a symbol like the ! in a triangle…
The ! is not a safeguard. Ultimately, the safeguard is some prescribed
behavior on the part of a person. The manufacturer of equipment can only
describe the desired behavior. The behavior can be tested to
I don't entirely agree, but the term is certainly vague and subjective.
The trouble is, it's embedded in step 4 of your procedure. I think we
have moved on from it now, but you will surely remember the requirement
for two layers of plastic film or insulation, in case one layer had a
pinhole.
West London, UK
From: Richard Nute [mailto:ri...@ieee.org]
Sent: 16 April 2018 21:48
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Medical device risk assessment - faulty chargers
I don’t like “risk assessment.” It is highly subjective and not scientific.
Read ISO 14971 or any
I don’t like “risk assessment.” It is highly subjective and not scientific.
Read ISO 14971 or any treatise on risk assessment.
I use the “energy transfer model.” This is not subjective and highly
scientific.
It was first proposed by James J. Gibson in 1961:
“Injuries to a liv
… 2 Means of Patient Protection (dielectric and spacings requirements)…
I trust this statement is a slip-up. Spacings i.e., clearances, are an indirect
measure of dielectric strength. They do not constitute two independent means
of patient protection.
Note that creepage distances ca
ments for single fault condition.
with best regards,
Ari Honkala
-Original Message-
From: Nick Williams [mailto:nick_willi...@conformance.co.uk]
Sent: tiistai 10. huhtikuuta 2018 19:21
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: [PSES] Medical device risk
Inc.
>
> From: "Ari Honkala"
> To: "EMC-PSTC"
> Sent: Wednesday, April 11, 2018 5:20:35 AM
> Subject: Re: [PSES] Medical device risk assessment - faulty chargers
>
> My first thought: what has the origin of the charger has to do with it being
> potentia
: "Ari Honkala"
To: "EMC-PSTC"
Sent: Wednesday, April 11, 2018 5:20:35 AM
Subject: Re: [PSES] Medical device risk assessment - faulty chargers
My first thought: what has the origin of the charger has to do with it being
potentially faulty? Any device may broke; that's w
willi...@conformance.co.uk]
Sent: tiistai 10. huhtikuuta 2018 19:21
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Medical device risk assessment - faulty chargers
Colleagues,
EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based
approach to the safety of their electrical medical pro
There is obviously no unique answer. You can:
- not use USB and provide a charger with a unique connector (my choice);
- use USB, but put full overvoltage and overcurrent protection in your
product;
- rely on warning notices (not recommended!)
John Woodgate OOO-Own Opinions Only
J M Woodgate
Colleagues,
EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based
approach to the safety of their electrical medical products.
With the increased used of universal USB power as a source for battery
charging, it’s easy for the risk assessment to identify use of the medica
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