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Hand sanitizers under ISO 13485

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Guest user Created:   May 14, 2020 Last commented:   May 15, 2020

Hand sanitizers under ISO 13485

1. Is our production (hand sanitizer) is under ISO 13485? For now, it is considered a cosmetic category? 2. If no, may I know which ISO fits it?
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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 May 15, 2020

According to the ISO 13485:2016, device that can be considered as medical devices is disinfectant substances. Here is the differentiation between similar products: sanitizers reduce bacteria on a surface by at least 99.9%, disinfectants kill a wider range of microorganisms (than sanitizers), and cleaners simply remove dirt, soils, and impurities from surfaces. 

So, if you declare that your hand sanitizer KILLS microorganisms, that it is disinfectant and is defined as a medical device that needs to be manufactured under ISO 13485:2016. If this is not your statement, then it is most probable that your product is a cosmetic product and needs to be produced in compliance with ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices.

For more information read the following article: 

In case you decide to implement ISO 13485:2016, following link can help to see which documentation is necessary: 

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May 14, 2020

May 15, 2020

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