Hi Peter,

IEC 60825-1 is the reference standard for laser devices labelling. 
In its EN version it is the reference for EU market.
In the US the reference is 21 CFR part 1040.10, but FDA also recognizes IEC
60825-1.

regards,
Paolo




 

------------------------------- 
Paolo Peruzzi 
Regulatory Medical R&D 
El.En. S.p.A. 
Via Baldanzese, 17 
50041 Calenzano (FI) 
Italy 
Tel. +39 055 8826807 
FAX  +39 055 8832884  
[email protected] <mailto:[email protected]> 
http://www.elengroup.com/ <http://www.elengroup.com/> 



Peter Weichel ha scritto: 

        Hi experts,
         
        I have two topics for which i need information:
         
        a)
        Which standard(s) regulate the marking requirements for labels to be 
put on
equipment using Class II laser devices ?
        And are there similar requirements for EU and USA ?
         
         
        b)
        Re. Li-Po batteries shipped inside equipment (internal) i wonder if IATA
regulations or others sets a maximum level of charge on such batteries when
shipped from factory. I.e. may a Li-Po battery be fully charged while shipping
inside equipment ?
         
        Thanks and have a nice day,
         
        Peter Weichel
        Denmark
         
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