IEC 60601-1:2012 - Impact Assessment for changes from IEC 60601-1:2005

K

KamakshiKariya

#1
Hello,

We are in compliance with the IEC 60601-1:2005 and I am currently working on an impact assessment for the changes made and released in IEC 60601-1:2012. Would be great if any of you would clarify on the following.

Clause 7.2.2 clarifies the labeling for the ME equipment as well it points to refer the symbols in the ISO 15223-1

1. Currently we specify the manufacturer name and city, do I need to specify the street address as well?
2. Is this mandatory to use the symbol for 'Manufacturer' from the ISO 15223-1?
3. Our label has a serial number notation 'S/N' however the Symbol in ISO 15223-1 is SN with an enclosure, is there a mandate to use the symbol from the ISO?
Thanks & Regards
Kamakshi Kariya.
 
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Mark Meer

Trusted Information Resource
#2
Unless you are going to have the device re-tested to the new version, I don't know if there's much to be concerned about.

What you really need to consider are the actual regional regulatory requirements.

For example, the EU MDD 93/42/EEC does have a requirement for the address to be stated (13.3(a)), but there is no obligation to use ISO symbols (13.2 does recommend use of symbols however...).
 
N

NickM

#4
International symbol usage are typically not mandatory (unless it is specifically called out in a standard/regulation). However, if you are not using international symbols and are using text instead, you may need to translate those terms to the language of the country you are shipping to. The international symbol for serial number is SN with a box around it. If you are using something other than that, you will need to be able to show that the symbol you are using is understandable to the the users (i.e., usability analysis). Thus, it is typically easier to use internationally recognized symbols (IEC & ISO) if they are available rather than creating your own.
 
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