Q
QA-RA-Newbie
Hi there!
I've used Elsmar Cove a lot over the past few years but this is my first post! Yay!
I have a question regarding symbols that tell the user to "consult accompanying documents" in one way or another for a Medical Electrical device. There are several symbols which appear to mean the same thing. How do you determine which should be included on labels, in manuals, or in software? Or do they all need to be used?
IEC 60601-1 3rd ed. - Table D.1 Symbol 11 is a book with an 'i' and means "operating instructions"
IEC 60601-1 3rd ed. - Table D.2 Symbol 10 is a blue circular safety sign with a person reading an instruction manual and means "Refer to instruction manual/booklet. Note: On ME Equipment "Follow instructions for use.""
ISO 15223-1:2007 - Section 5 Table 1 Symbol 5.3 is a book with an 'i' and means "consult instructions for use"
ISO 15223-1:2007 - Section 5 Table 1 Symbol 5.4 is a white triangle with an '!' and means "caution, consult accompanying documents."
When is it appropriate to use each of those symbols?
Thanks in advance and I hope I've included enough information!
I've used Elsmar Cove a lot over the past few years but this is my first post! Yay!
I have a question regarding symbols that tell the user to "consult accompanying documents" in one way or another for a Medical Electrical device. There are several symbols which appear to mean the same thing. How do you determine which should be included on labels, in manuals, or in software? Or do they all need to be used?
IEC 60601-1 3rd ed. - Table D.1 Symbol 11 is a book with an 'i' and means "operating instructions"
IEC 60601-1 3rd ed. - Table D.2 Symbol 10 is a blue circular safety sign with a person reading an instruction manual and means "Refer to instruction manual/booklet. Note: On ME Equipment "Follow instructions for use.""
ISO 15223-1:2007 - Section 5 Table 1 Symbol 5.3 is a book with an 'i' and means "consult instructions for use"
ISO 15223-1:2007 - Section 5 Table 1 Symbol 5.4 is a white triangle with an '!' and means "caution, consult accompanying documents."
When is it appropriate to use each of those symbols?
Thanks in advance and I hope I've included enough information!