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Table 2 Biocompatibility results after 3x specialty cycle exposure

From: Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices

Material

Evaluation

Cytotoxicity*

ISO 10993-5

Sensitization**

ISO 10993-10

Intracutaneous Irritation testing**

ISO 10993-23

Systemic Toxicity**

ISO 10993-11

Material Mediated Pyrogenicity**

ISO 10993-11

Hemocompatibility**

ISO 10993-4 and ASTM F756

Formlabs BioMed Amber

Not cytotoxic

Not sensitizing

Not an irritant

Not a systemic toxin

Not pyrogenic

Hemo-compatible

Formlabs BioMed Clear

Not cytotoxic

Not sensitizing

Not an irritant

Not a systemic toxin

Not pyrogenic

Hemo-compatible

Stratasys MED610

Not cytotoxic

Not sensitizing

Not an irritant

Not a systemic toxin

Not pyrogenic

Hemo-compatible

Stratasys MED615

Not cytotoxic

Not sensitizing

Not an irritant

Not a systemic toxin

Not pyrogenic

Hemo-compatible

Stratasys MED620

Not cytotoxic

Not sensitizing

Not an irritant

Not a systemic toxin

Not pyrogenic

Hemo-compatible

  1. * Testing conducted at STERIS in accordance with ISO 10993-5 standard under Good Laboratory Practice (GLP) regulations as provided in 21 CFR § 58
  2. ** Testing conducted at NAMSA in accordance with the identified ISO 10,993 standards. NAMSA is certified to ISO 9001:2015 and is accredited to ISO/IEC 17025:2017