ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Question

C

cartman1417

#1
Background: Our device is a Class IIa diagnostic medical device. It is a cart based system for vaginal examination, and uses a transvaginal probe for examination (similar to an ultrasound probe). The system consists of a touch screen monitor on medical cart and other parts/components.

The probe is covered with a disposable sheath/cover and hence the probe is reusable but might need to be "disinfected" (not sterilized) at periodic intervals, by soaking in chemicals. The touch-screen monitor will either be covered with a disposable cover or be disinfected by disinfection wipes.

So how do I go about writing the content of the clause 7.5.1.2.1? Could anyone please suggest?

Reference:
7.5.1.2.1 Cleanliness of product and contamination control
The organization shall establish documented requirements for cleanliness of product if
a) product is cleaned by the organization prior to sterilization and/or its use, or
b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or
c) product is supplied to be used non-sterile and its cleanliness is of significance in use, or
d) process agents are to be removed from product during manufacture.
If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4 a) and 6.4 b) do not
apply prior to the cleaning process.

 
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Stijloor

Staff member
Super Moderator
#2
Re: ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Quest

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
 

DannyK

Trusted Information Resource
#3
Re: ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Quest

The procedure should define the product cleanliness requirements, use of process agents, and decontamination processes if it applies.
 

somashekar

Staff member
Super Moderator
#4
Re: ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Quest

Reference:
7.5.1.2.1 Cleanliness of product and contamination control
The organization shall establish documented requirements for cleanliness of product if
a) product is cleaned by the organization prior to sterilization and/or its use, or
b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or
c) product is supplied to be used non-sterile and its cleanliness is of significance in use, or
d) process agents are to be removed from product during manufacture.
If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4 a) and 6.4 b) do not
apply prior to the cleaning process.
Most likely your product or precisely the transvaginal probe for examination could fall under the highlighted in blue category as in above.
So have a documented procedure how the factory does this "The disinfecting (not sterilizing) before the final packing, by soaking in chemicals, and how these chemicals are further removed, making the transvaginal probe ready to use by the technician for the first time."
The rest of your product can be cleaned by whatever method that you deem fit and need not be covered within your procedure
 
C

cartman1417

#5
Re: ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Quest

How do I decide whether b) applies or c) ?

b) product is supplied non-sterile to be subjected to a cleaning process prior to its use, or
c) product is supplied to be used non-sterile and its cleanliness is of significance in use, or

 

somashekar

Staff member
Super Moderator
#6
Re: ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Quest

How do I decide whether b) applies or c) ?

b) product is supplied non-sterile to be subjected to a cleaning process prior to its use, or
c) product is supplied to be used non-sterile and its cleanliness is of significance in use, or

b) As you say, the device is supplied non-sterile. So are you supplying it in a way ready to use, OR do you say within your device information for use that the device has to be cleaned before the first use in a specified way ?
c) Does your device risk management address the significance of cleanliness in its use ? towards this, do you supply the device with necessary cleaning ? OR
Do you recommend the cleaning method for the cleaning of the device before the first use to the technician ?

I am sure you have addressed this in the risk management, since you have mentioned above in post #1 this:
The probe is covered with a disposable sheath/cover and hence the probe is reusable but might need to be "disinfected" (not sterilized) at periodic intervals, by soaking in chemicals.
 
C

cartman1417

#7
Re: ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Quest

b) As you say, the device is supplied non-sterile. So are you supplying it in a way ready to use, OR do you say within your device information for use that the device has to be cleaned before the first use in a specified way ?
c) Does your device risk management address the significance of cleanliness in its use ? towards this, do you supply the device with necessary cleaning ? OR
Do you recommend the cleaning method for the cleaning of the device before the first use to the technician ?

I am sure you have addressed this in the risk management, since you have mentioned above in post #1 this:
The probe is covered with a disposable sheath/cover and hence the probe is reusable but might need to be "disinfected" (not sterilized) at periodic intervals, by soaking in chemicals.
Our risk management does address the cleaning issue. From your questions, it seems to me that c) applies in our case.

We would be the suppliers of the probe covers as well. The probe needs to be disinfected if there is apparent rupture in the cover during/after examination or once every week otherwise. We will provide specific instructions on which chemicals to use and the procedure.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Re: ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Quest

Those are not exclusive-or's (xor's). One could have any combination of a, b, c and/or d apply in a specific instance.
 
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