Evidence - Class IIb Disinfectant Sanitiser

mikinnear

Starting to get Involved
Hi All, :bigwave:

I have been searching for a couple of days for the answers I seek with no avail. I thought the great minds here might be able to assist.

I am implementing ISO 13485:2016 for a client for a class IIb disinfectant preparation for "disinfecting intrusive medical devices".

It's my first time working with a disinfectant medical device, and I would like to know if there is a list of microbiological standards needed to prove efficacy and a list of pathogens that need to be tested against.

I have an idea from other products but any official literature would be ideal.

Does anyone have any information on this?

Many thanks,
Mike.

:thanx:
 
Last edited:

planB

Super Moderator
Mike,

unfortunately you are completely off-track:

1) "Disinfection" and "Sterilisation" are two separate things.

2) I guess your device falls under MDD 93/42/EEC, Annex IX, rule 15:
All devices intended specifically to be used for disinfecting medical devices are in Class IIa. ►M5 Unless they are specifically to be used for disinfecting invasive devices, in which case they are in Class IIb.

So you might want to look for and educate yourself about "disinfection of invasive medical devices"; otherwise, sorry - no free lunch from my side with a list of standards/literature, ready to sell to your customer.

HTH,

Gerhard
 
N

Noemi1976

Hello :bigwave:
I can suggest that you have a look at:
  • EN 13727:2012+A2:2015 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
  • EN 14561:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
  • EN 13624:2013 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
  • EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
  • EN 14348:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
  • EN 14563:2008 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
  • EN 14476:2013+A1:2015 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
I hope it helps.
 
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