CERTIFIED SAFETY
FOR MEDICAL & WELLNESS STAFF
The garments from the 100%YOU line have received the following certifications:
Personal Protective Equipment category I (PPE)
Reg. (EU) 2016/425 – Annex I – Cat. I, lett. b)
Medical Device class I
Reg. (EU) 2017/745 (MDR)
Laboratory tests and Certifications
Personal Protective Equipment category I (PPE)
Reg. (EU) 2016/425 – Annex I – Cat. I, lett. b)
Medical Device class I
Reg. (EU) 2017/745 (MDR)
Laboratory tests and Certifications
Personal Protective Equipment category I (PPE)
Reg. (EU) 2016/425 – Annex I – Cat. I, lett. b)
The fabric has passed the following tests:
14350 Fabrics. Surface wetting. Spray test. Testing method: UNI EN ISO 4920:2013
15125 Non-woven fabrics. Traction and elongation. Strip method.
Testing method: UNI EN 29073-3:1993
15170 Non-woven fabrics. Tearing. Trapezoid procedure.
Testing method: UNI EN ISO 9073-4:1999
70340 Protective clothing. Traction of seams. Grab test.
Testing method: UNI EN ISO 13935-2:2014 + UNI EN 14325:2005 (Par.5.5) + UNI EN 13034:2009 Par.4.2.2 Product standard: UNI EN 13034:2009
70831 Protective clothing, textile. pH of aqueous extract. Testing method: UNI EN ISO 3071:2020 + UNI EN ISO 13688:2013 Par.4.2 Product standard: UNI EN ISO 13688:2013
70831 Protective clothing, textile. pH of aqueous extract. Testing method: UNI EN ISO 13688:2013 Product standard: UNI EN ISO 3071:2020 + UNI EN ISO 13688:2013 Par 4.2
76219 Protective clothing. Aromatic amines derived from azo colourants. Testing method: UNI EN ISO 13688:2013 Product standard: UNI EN 14362-1:2017 + UNI EN ISO 13688:2013 Par 4.2
Medical Device class I
Reg. (EU) 2017/745 (MDR)
The fabric has passed the following tests:
- 14350 Fabrics. Surface wetting. Spray test Testing method: UNI EN ISO 4920:2013
- 15125 Non-woven fabrics. Traction and elongation. Strip method. Testing method: UNI EN 29073-3:1993
- 15170 Non-woven fabrics. Tearing. Trapezoid procedure. Testing method: UNI EN ISO 9073-4:1999
- 70340 Protective clothing. Traction of seams. Grab test. Testing method: UNI EN ISO 13935-2:2014 + UNI EN 14325:2005 (Par.5.5) + UNI EN 13034:2009 Par.4.2.2 Product standard: UNI EN 13034:2009
- 70831 Protective clothing, textile. pH of aqueous extract. Testing method: UNI EN ISO 3071:2020 + UNI EN ISO 13688:2013 Par.4.2 Product standard: UNI EN ISO 13688:2013
- 70831 Protective clothing, textile. pH of aqueous extract. Testing method: UNI EN ISO 13688:2013 Product standard: UNI EN ISO 3071:2020 + UNI EN ISO 13688:2013 Par 4.2
- 76219 Protective clothing. Aromatic amines derived from azo colourants. Testing method: UNI EN ISO 13688:2013 Product standard: UNI EN 14362-1:2017 + UNI EN ISO 13688:2013 Par 4.2