Identifying version of Standards in Functional Specification of a New Device

J

Jennifer27

#1
Hi Experts!

I have recently created functional specification of a new device. In the acceptance criteria of the functional specs we have mentioned standards (e.g. if it is a body contacting material then we have listed ISO 10993 standard, if electrical then 60601 standard).

My question is when in device's functional specs we enlist standards that the device complies with should we also mention the year (e.g., ISO 10993-3:2003 and ISO 10993:3- 2009) OR is it enough to simply mention the standard without year (e.g., ISO 10993:3, 60601-1).

I believe mentioning year would be good - so that we know to which standard was the device tested to...on the other hand if we mention year in functional spec each time we do new testing per new standards we will have to update the functional specs as well ---Which will bee a lot of extra work.

Is there any requirement in US or EU regulations -- requiring us to mention the year of standards -- If yes could you please provide me reference

If there is no such requirement listed in regulations/guidance document - Can we simply state standards (without year)

(This device is to be marketed in US and EU)

Any suggestions will be very helpful.

Thanks a lot
Jen
 
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rob73

looking for answers
#2
Jen
Leave the date in, MDD 93/42 states in annex 1 para 2.
"The solutions adopted by the manufacturer for the design and
construction of the devices must conform to safety principles, taking
account of the generally acknowledged state of the art"
Using the latest standard helps with this, so having the date would tell an auditor/CB that you are working to the latest standard (providing that you are of course).
just my :2cents:
 
S

SteveK

#3
Hi Jen,

Personally I reference the year in my Technical File documentation - I have a specific section for standards applied (as suggested by a NB TF reviewer). This is also the case in my Essential Requirements section. It is a pain to keep such things updated (I have 14 device TFs) - but although I do not think there is a specific requirement for referencing a standard's year, there is the bit in MDD 93/42/EEC about "state of the art", e.g. section 2, Annex I. It is this type of thing auditors could pick up on if the current version of a standard was not referenced. This only my opinion - lets see what other input you get. As an extra - where necessary I conduct a 'gap analysis' i.e. old standard vs current, and conduct some further testing where practical.

Steve
 
#4
In a specification I would include the date to show which version was used for the design phase.

However I don't think that this would need to be updated unless the product's specification was revised.
 

Marcelo

Inactive Registered Visitor
#5
When you mention the year, it means the specific standard. When you mention only the standard. it means the last version.

Reg systems usually use a particular version, so it?s advisable to use the year in your documentation.
 
A

Adele

#7
I am in favour of including the year of the standard you design to. A new revision of a standard may result in new requirements and new specifications whihc may involve an update of the funcational specifications anyway.
 
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