There are two types of EU legal Frameworks applicable are:
- Regulation (EU) 2016/425: For face mask as PPE
- Regulation (EU) 2017/745 (superseded from Council directive 93/42/EEC): For medical gloves, surgical masks, intensive care & other medical equipment that come under the scope of EU legal framework on medical devices.
|Face Mask Type||Regulation||Standard||NB Involvement||Testing Required|
|Surgical masks||Regulation (EU) 2016/425||EN 14683||Not Needed||By Independent Lab|
|Face masks||Regulation (EU) 2017/745||EN 149+ EN 14683||In Design Examination||By NB Laboratory|
Applicable EU Standards
- Under PPE, any technical solution may be used by manufacturer to meet the essential requirement.
- For Face Masks,
- EN 149:2001+A1:2009 for FFP Type mask
- EN 14683:2019 for Surgical Type mask