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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

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