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Contamination/requirements for sterile medical device contamination intro vitro diagnostic device (IVD) (i.e. IVD)?

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Guest user Created:   Nov 16, 2020 Last commented:   Nov 20, 2020

Contamination/requirements for sterile medical device contamination intro vitro diagnostic device (IVD) (i.e. IVD)?

I seeing in the 13485 requirements. would this requirement be applicable to IVD ? Currently we we are not sterilizing anything? Could you please provide a list of items that would require sterilizing in the process/lab per the clauses listed in the standard below? Arrangements for the control of contaminated or potentially contaminated product 6.4.2 Requirements for control of sterile medical device contamination 6.4.2 Thank you in advice. I am confused and need confirmation/clarity.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Nov 17, 2020

Yes, ISO 13485:2016 is applicable for all manufacturers of medical devices, and In vitro diagnostic products are classified as medical devices. If you are not sterilizing your products, it is OK. You do not need to fulfill that requirement. In section 1 Scope is stated that if any requirement in Clauses 6, 7, and 8 is not applicable due to the activities undertaken by the organization or the nature of the medical device, the organization does not need to include such requirements in its Quality management system. Therefore, you will in your quality manual state that requirements regarding sterilization are not applicable for you (7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems). 

Considering the requirement 6.4.2 Contamination control, arrangements for the control of the contaminated or potentially contaminated product, you have to take into consideration how you can contaminate your product, is it necessary to be produced in the cleanroom, have you ensure that there is no cross-contamination between raw material and final product movement and so on. 

If your medical device is not sterile, requirements for control of sterile medical device contamination are not applicable for you, and therefore you won't write anything for that matter. 

Following articles can be helpful:

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Guest user Nov 17, 2020

Thank you for the information.

Other questions:

Considering the requirement 6.4.2 Contamination control, arrangements for the control of the contaminated or potentially contaminated product, you have to take into consideration how you can contaminate your product, is it necessary to be produced in the cleanroom, have you ensure that there is no cross-contamination between raw material and final product movement and so on.

1. What would you suggest on measures that could be taken to implement contamination control and work instruction/procedure with a checklist maybe?

2. Also, Is there a Quality Manual checklist anywhere that actually provides me with the requirements that the Quality Manual must include?

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Kristina Zvonar Brkić Nov 20, 2020
1. What would you suggest on measures that could be taken to implement contamination control and work instruction/procedure with a checklist maybe?

To answer this question, I need to know what kind of medical device you have. Contamination control is definitively depending on the type of medical devices.

2. Also, Is there a Quality Manual checklist anywhere that actually provides me with the requirements that the Quality Manual must include?

Following article can help you to prepare the Quality manual for ISO 13485:2016:

Also, you can see on this link how we have prepared the Quality Manual in our ISO 13485:2016 documentation toolkit:

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