Is clean room installation mandatory?

No, there is no strict requirement in ISO 13485:2016 that the cleanroom has to be installed. However, stated is the following:

In section 6.4.1 Work environment, is stated that the manufacturer needs to document requirements for the work environment needed to achieve conformity of the product with the specification. If the conditions of the work environment have adverse effects on product quality, besides documenting the requirements for the work environment, the manufacturer also must document the procedure foto monitro and control the work environment. Therefore, it is the manufacturer's decision depending on the type of the medical device, will cleanroom will be installed or not.In section 6.4.2 Contamination control, for sterile medical devices is stated that manufacturer must document requirements for control of contamination with microorganisms or particular matter and maintain the required cleanliness during assembly or packaging process.

For more information on this topic, please see the following articles:

• Managing cleanliness of a product and contamination control according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/07/04/managing-cleanliness-of-a-product-and-contamination-control-according-to-iso-134852016/
• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/