The most typical requirements for marking plate

 

7.2.3 Consult ACCOMPANYING DOCUMENTS 

• symbol ISO 7000-1641 (2004-01)   - advise the OPERATOR to consult the ACCOMPANYING DOCUMENTS 

• safety sign ISO 7010-M002  - consulting the ACCOMPANYING DOCUMENTS is a mandatory action 

Note: The Blue colour is required for the label, but has been accepted in monochrome in instruction for use.

7.2.9 IP classification 

ME EQUIPMENT classified IPX0 or IP0X need not be marked.

7.2.11 Mode of operation

If equipment intended for non-continuous operation duty cycle shall be indicated with the maximum „on” and the minimum „off” time.

Example: 

 7.2.12 Fuses

If fuseholder accessible the type and full rating of the fuse shall be marked:

• voltage

• current

• operating speed

• breaking capacity

Minimum requirements for marking on ME EQUIPMENT and on interchangeable parts 

„If the size of the ME EQUIPMENT, an ME EQUIPMENT part or an ACCESSORY, or the nature of its ENCLOSURE, does not allow affixation of all markings specified in 7.2.2 to 7.2.20 (inclusive), then at least the markings as indicated in 7.2.2, 7.2.5, 7.2.6 (not for PERMANENTLY INSTALLED ME EQUIPMENT), 7.2.10 and 7.2.13 (if applicable) shall be affixed and the remaining markings shall be recorded in full in the ACCOMPANYING DOCUMENTS. Where no marking of the ME EQUIPMENT is practicable, these markings may be affixed to the individual packaging.” 7.2.1 in 60601-1 Ed3.1

• 7.2.2 Indentification

o the name or trademark and contact information of the MANUFACTURER 

o a MODEL OR TYPE REFERENCE 

o a serial number or lot or batch identifier; and 

o the date of manufacture or use by date, if applicable. 

• 7.2.5 ME EQUIPMENT intended to receive power from other equipment

o the name or trademark of the manufacturer of the other electrical equipment with a MODEL OR TYPE REFERENCE of the specified other equipment adjacent to the relevant connection point; 

o placing safety sign ISO 7010-M002 (see Table D.2, safety sign 10) adjacent to the relevant connection point and listing of the required details in the instructions for use; or 

o using a special connector style that is not commonly available on the market and listing of the required details in the instructions for use. 

• 7.2.6 Connection to the SUPPLY MAINS 

o the RATED supply voltage(s), for example, 100V/240V

o RATED voltage range(s), for example 100-240V

o nature of supply, for example, AC   or DC  

o RATED supply frequency or RATED frequency range, for example 50Hz or 50/60Hz

o For CLASS II ME EQUIPMENT, symbol IEC 60417-5172 (2003-02)  

• 7.2.10 Applied parts

o Type B applied part  

o Type BF applied part  

o Type CF applied part  

o Or DEFIBRILLATION-PROOF B, BF or CF      

• 7.2.13 Physiological effects 

o ME EQUIPMENT producing physiological effects that are not obvious to the OPERATOR and can cause HARM to the PATIENT or OPERATOR shall bear a suitable safety sign