ISO Dental Device Packaging Testing

Project Description

Medical Device Laboratory needed for ISO testing of dental device packaging according to the following ISO Test Standards:

 Break loose and extrusion forces according to ISO 11040 - 4:2015
 Burst resistance according to ISO 11040-4:2015, G.2
 Break resistance according to ISO 11040-4:2015, 5.4.4, ISO 11040-4:2015, 5.4.5
 Closure system forces and torques according to ISO 11040-4:2015, G.3 to G.6
 Connectivity with fluid path connectors according to ISO 80369-1, ISO 80369-7 and ISO 80369-20
 Residual volume according to ISO 11040-4:2015, 6.5.1.3
 Needle penetration force according to ISO 11040-4:2015, Annex F.
 Needle pull-out force according to ISO 11040-4:2015, 6.5.2.5
 Sharps injury protection requirements according to ISO 23908
 Liquid leakage beyond plunger according to ISO 7886-1:2015, Annex B

Regarding the syringe's package materials:

3.1.6. POLYPROPYLENE
 Appearance of solution (According to EUROPEAN PHARMACOPOEIA 01/2008:30106 corrected 7.0)
 Acidity or alkalinity (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Absorbance (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Reducing substances (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Substances soluble in hexane (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Extractable aluminium (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Extractable chromium (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Extractable titanium (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Extractable vanadium (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Extractable zinc (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Extractable heavy metals (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Sulfated ash (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Phenolic antioxidants. (Papildomi) (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Non-phenolic antioxidants(Papildomi) (According to Ph. Eur 01/2008:30106 corrected 7.0)
 Amides and stearates. (According to Ph. Eur 01/2008:30106 corrected 7.0)

3.1.4. - 3.1.5. POLYETHYLENE
 Appearance of solution (According to EUROPEAN PHARMACOPOEIA 01/2008:30105 corrected 7.0)
 Acidity or alkalinity (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Absorbance (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Reducing substances (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Substances soluble in hexane (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Extractable aluminium (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Extractable chromium (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Extractable titanium (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Extractable vanadium (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Extractable zinc (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Extractable heavy metals (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Sulfated ash (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Additives (According to Ph. Eur 01/2008:30104 corrected 6.0)
 Phenolic antioxidants (According to Ph. Eur 01/2008:30105 corrected 7.0)
 Non-phenolic antioxidants (According to Ph. Eur 01/2008:30105 corrected 7.0)

Regards