

Technische Informationen
Vorschrift
MDD 93/42/EC, 2007/47/EC | Medical Devices Directive |
EN 149:2001 + A1:2009 | Respiratory protective devices |
ISO 15223-1:2016 | Medical devices – Symbols to be used with medical devices, labels, labelling and information to be supplied. Part 1: General requirements. |
EN 1041+A1:2013 | Information supplied by the manufacturer of medical devices. |
EN 14971:2019 | Medical Devices – Application of Risk Management |
ISO 10993-10:2013 | Biological evaluation of medical devices. Part 10: Test for irritation and skin sensitization. |
ISO 16142-1:2016 | Medical devices-Recognized essential principles of safety and performance of medical devices. Part 1: General essential principles and additional specific principles for all non-IVD medical devices guidance on the selection of standards. |
EN 62366-1:2015 | Medical devices. Part 1: Application of usability engineering to medical devices |
GMDN | 35177 |
CE | CE 2797 |
EU 2016/425 | Personal Equipment Regulation |
EU MDR 2017/745 | Medical Devices Regulations |
Material
First layer | Spunbond PP nonwoven fleece, orange |
Second layer | Meltblown PP nonwoven, white |
Third layer | Meltblown PP nonwoven, white |
Fourth layer | Colback nonwoven |
Fifth layer | Spunbond PP hydrophobic, white |
Head loop | Nylon/Spandex |
Nose clamp | Aluminum (between the nonwoven layers) |