C
cartman1417
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.
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.