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ISO 13485 and cleaning process

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Guest user Created:   Mar 08, 2021 Last commented:   Mar 10, 2021

ISO 13485 and cleaning process

I need what ISO 13485 says about cleaning process.

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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.

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Kristina Zvonar Brkić Mar 10, 2021

Cleaning is covered in the ISO 13485 in the following requirements: 6.4.1 Work environment and 6.4.2 Contamination control. There is no instruction how cleaning should be performed, there is even criteria which would be the required level of cleanliness for a particular product.  It is manufacturer responsibility  to define the requirements for health, cleanliness, clothing of personnel, contamination control.

For more information on this topic, please see following article:

You can see in our ISO 13485:2016 Documentation toolkit how this procedure looks like:

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