DACH Neolution®Air FFP2 NR D Respirator, Type IIR, Class III PPE – Cleanroom & Medical Use

DACH Neolution®Air is a high-performance particle filtering half mask designed for both cleanroom and medical use, combining excellent filtration efficiency with exceptional wearer comfort. The mask is classified as PPE Category III under Regulation (EU) 2016/425 and as a Class I Medical Device under Regulation (EU) 2017/745, making it suitable for use in controlled cleanroom environments as well as clinical and healthcare settings.

The respirator meets the requirements of FFP2 NR D according to EN 149:2001+A1:2009 and additionally complies with Type IIR medical face mask requirements under EN 14683:2019+AC:2019 in terms of bacterial filtration efficiency, splash resistance and microbial cleanliness. Use in cleanrooms is recommended according to EN ISO 14644-1, from ISO Class 3 to ISO Class 9, supported by Helmke Drum Test results in accordance with IEST-PR-CC003.4.

The three-panel design allows the mask to follow jaw movements during speech, ensuring a consistently tight seal and high wearing comfort. A textile elastic head strap provides a secure fit without pressure points or hair pulling. High-tech filter media delivers very high filtration performance against solid and liquid aerosols while maintaining extremely low breathing resistance. The mask has also passed the voluntary dolomite dust clogging test, ensuring reliable performance even under demanding conditions.

Key Features

– Particle filtering half mask FFP2 NR D according to EN 149:2001+A1:2009
– Also compliant with Type IIR medical face mask requirements according to EN 14683:2019+AC:2019
– Suitable for cleanroom use from ISO Class 3 to ISO Class 9
– PPE Category III and Class I Medical Device
– Three-panel design for constant tight fit during movement and speech
– Very low breathing resistance with high filtration performance
– Textile elastic head straps for secure and comfortable fit
– Metal nose clip with plastic coating for optimal adjustment
– Free from natural latex

Filtration and Performance

– FFP2 maximum penetration requirement: ≤6%
– Actual penetration (NaCl, 95 l/min): 0.84%
– Bacterial filtration efficiency (Type IIR): >99.7%
– Splash resistance pressure (Type IIR): 16.0 kPa
– Differential breathing resistance well below maximum limits
– Carbon dioxide content of inhaled air: 0.68%

Cleanroom Performance

– Helmke Drum Test according to IEST-PR-CC003.4, Category I
– Extremely low particle emission across all measured particle sizes
– Suitable for controlled and classified cleanroom environments

Biocompatibility

– Tested according to EN ISO 10993-5 (cytotoxicity)
– Tested according to EN ISO 10993-10 (sensitisation)
– Tested according to EN ISO 10993-23 (irritation)
– Materials are non-cytotoxic, non-sensitising and non-irritating

Standards and Certifications

– PPE Category III according to Regulation (EU) 2016/425
– Class I Medical Device according to Regulation (EU) 2017/745
– EN 149:2001+A1:2009 (FFP2 NR D)
– EN 14683:2019+AC:2019 Type IIR
– EN ISO 14644-1 (cleanroom use)
– IEST-PR-CC003.4 Helmke Drum Test

Applications

– Pharmaceutical and biotechnology cleanrooms
– Hospitals and healthcare environments
– Laboratories and controlled environments requiring dual cleanroom and medical compliance

View the product data sheet by clicking HERE