Medical Device Labeling Standards References

R

ramkannan13

Hello all,

On Medical device Labelling Standards, is anyone aware about the STANDARDS used as refernces / guide in a liability issue on a Product safety .



FYI
E.U they use EN 980:2008, EN 1041:2008, ISO 38624 and ISo 15223 .

USA : FDA Labelling Guidance Document and ANSI 535.4 .

Apart from the above STANDARDS are there any ..... Im missing? .

Thanks,
Rk
 
S

SteveK

Re: Labelling STANDARDS

Hi Rk,

There is BS EN 15986:2011 “Symbol for the use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates”.

Steve
 
S

SteveK

Re: Labelling STANDARDS

Forgot – of course there are all the symbols in IEC 60601-1 for medical electrical equipment, which I would think are applicable.

Steve
 
R

ramkannan13

Re: Labelling STANDARDS

Hi Rk,

There is BS EN 15986:2011 “Symbol for the use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates”.

Steve
Steve, you're right I did not mention that because our medical device does not contain any phthalates. Now my question for you ...So even if the product does not contain phthalates still using the Standard will it help me anyways?

And also our product does not use any electricity or electrical components.
 
S

SteveK

Re: Labelling STANDARDS

Steve, you're right I did not mention that because our medical device does not contain any phthalates. Now my question for you ...So even if the product does not contain phthalates still using the Standard will it help me anyways?

And also our product does not use any electricity or electrical components.

Wih respect to BS EN 15986 (Phthalates) FYI I will quote what it says in Annex B of the Standard:

Use of the negation symbol

Manufacturers wishing to communicate the meaning "does no" or "is not" where a symbol expressing this meaning does not exist, should follow the method set out in EN 80416-3:2002, Clauses 7 (for the 'negation sysmbol', a large 'X' placed over the symbol). Although it is not generally recommended to use this symbology with the symbol given in this European Standard, the use of the negation symbol is permitted.

I hope this helps.

By the way, BS EN 80416-3:2002 is "Basic principles for graphical symbols for use on equipment. Guidelines for the application of graphical symbols"

To really go OTT, because I am certain you were dying to know:rolleyes::

BS EN 80416-1:2009 is "Basic principles for graphical symbols for use on equipment. Creation of graphical symbols for registration"

BS EN 80416-2:2001 is "Basic principles for graphical symbols for use on equipment. Form and use of arrows"

Steve
 
R

ramkannan13

Re: Labelling STANDARDS

Wih respect to BS EN 15986 (Phthalates) FYI I will quote what it says in Annex B of the Standard:

Use of the negation symbol

Manufacturers wishing to communicate the meaning "does no" or "is not" where a symbol expressing this meaning does not exist, should follow the method set out in EN 80416-3:2002, Clauses 7 (for the 'negation sysmbol', a large 'X' placed over the symbol). Although it is not generally recommended to use this symbology with the symbol given in this European Standard, the use of the negation symbol is permitted.

I hope this helps.

By the way, BS EN 80416-3:2002 is "Basic principles for graphical symbols for use on equipment. Guidelines for the application of graphical symbols"

To really go OTT, because I am certain you were dying to know:rolleyes::

BS EN 80416-1:2009 is "Basic principles for graphical symbols for use on equipment. Creation of graphical symbols for registration"

BS EN 80416-2:2001 is "Basic principles for graphical symbols for use on equipment. Form and use of arrows"

Steve
Steve,

Thank you so much , I really appreciate your help very useful info.

Rk
 
V

Volfhart

Is the device packaging considered part of the device and therefore the package labeling design documentation need to be a controlled document? Would the device packaging be a part of the BOM? I am seeing conflicting opinions.
Thanks all.
 

J0anne

Joanne
FYI
E.U they use EN 980:2008, EN 1041:2008, ISO 38624 and ISo 15223 .

USA : FDA Labelling Guidance Document and ANSI 535.4 .

Apart from the above STANDARDS are there any ..... Im missing? .

Thanks,
Rk

You don't need all those.

980 will be sufficient for Europe and FDA labeling Regs for marketing in the US.

With regard to safety - 14971 is a good way to go and will fulfill your usability requirements at the same time.
 
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