Requirements for Medical Gown Production under ISO 13485

There are no strict requirements regarding environmental criteria for the manufacturing of medical gowns. According to the ISO 13485:2016, requirement 6.4.1 Work environment, the organization must document requirements for the work environment needed to ensure that the final product is in conformance with the requirements and specifications. If the medical device is sterile, the manufacturer must document requirements for control of contamination with microorganisms. It means that it is up to the manufacturer to decide which cleanroom classification he will use and how will he control that medical device is sterile. Usually, manufacturers of medical gowns have a cleanroom class ISO 7 according to the ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration. 

A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity, and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 microns and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used. Cleanrooms are classified by how clean the air is and according to the number and size of particles permitted per volume of air.  

For more information about the cleanliness of medical device production, 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/

You can also see in our ISO 13495:2016 Documentation toolkit how Procedure for Infrastructure and work environment look like on the following link: https://advisera.com/13485academy/documentation/procedure-for-infrastructure-and-work-environment-iso-13485-2016/