Hazard symbols and labeling

[DonkeyKang]

Hello everyone,

What standard(s) does everyone use to determine the hazard labeling on your medical device? ISO 7000 and ISO 7010 appear to be a collection of symbols which may be purchased individually for use, making purchase of the entire standard(s) unnecessary. Is there a standard/guidance that explains which symbols to use for specific scenarios? Specifically, we are looking for guidance on symbols prohibiting the use of the device near life-sustaining devices such as pacemakers, etc. P-007 is a symbol prohibiting access for people with active implanted cardiac devices (seems to be appropriate to place on a door) but we are looking for something to put on the device physically and on the user screen during use. Any help would be appreciated.

Thanks in advance.

 

[J0anne]

Hello everyone,

What standard(s) does everyone use to determine the hazard labeling on your medical device? ISO 7000 and ISO 7010 appear to be a collection of symbols which may be purchased individually for use, making purchase of the entire standard(s) unnecessary. Is there a standard/guidance that explains which symbols to use for specific scenarios? Specifically, we are looking for guidance on symbols prohibiting the use of the device near life-sustaining devices such as pacemakers, etc. P-007 is a symbol prohibiting access for people with active implanted cardiac devices (seems to be appropriate to place on a door) but we are looking for something to put on the device physically and on the user screen during use. Any help would be appreciated.

Thanks in advance.

60601 and 820/15223

There's a draft version of the new 60601 available for purchase and it's only £20 for non members

19/30357110 DC - BS IEC 60601-1 AMD2. Medical electrical equipment. Part 1. General requirements for basic safety and essential performance