Chromed Biosciences Pvt. Ltd., Is a CCSEA / CPCSEA Registered, ISO & IBSC approved, CDSCO & NABL ISO / IEC – 17025 Accredited Laboratory, committed to provide best-in-class Preclinical / Non-Clinical Research support for Medical Devices Pharma, Herbal, Biotech, Cosmetics, Poultry, VeterinaryResearch in compliance with OECD GLP / ISO / and as per other National and other International Guidelines and regulations.
At Chromed, Biocompatibility and Biological evaluations of Medical Devices are carried out in line with ISO 10993 Guidelines.
Apart from Medical Device Testing, Chromed Biosciences, also imparts Preclinical Research services.
Biocompatibility Evaluation Endpoints
Cytotoxicity: ISO 10993 (Part 5), 2009
In Vitro Cytotoxicity
Toxicity: ISO 10993 (Part 11)
Acute Systemic Toxicity Test
Systemic Toxicity Test (Subacute, Sub chronic & Chronic)
Material Mediated Pyrogenicity Test: ISO (Part 11 & USP 131)
Genotoxicity: ISO 10993 (Part 3)
Bacterial Reverse Mutation / Ames Test
In Vitro Micronucleus Test
In Vitro Chromosomal Aberration Test
In Vivo Mammalian Chromosomal Aberration Test
In Vivo Mammalian Micronucleus Test
Mouse Lymphoma Assay
Irritation: ISO 10993 (Part 23) Intracutaneous Reactivity Test
Ocular Irritation
Vaginal Irritation
Penile Irritation
Oral Mucosal Irritation Test
In vitro: RhE and RhCE irritation Model (OECD – 492)
Tests for Local Eects After Implantation: ISO 10993 (Part 6)
Intramuscular Implantation
Subcutaneous Implantation
Bone Implantation
Sensitization: ISO 10993 (Part 10)
Guinea Pig Maximization Test
(Magnusson & Kligman)
Buehler Test
Hemocompatibility: ISO 10993 (Part 4)
Hemolysis (ASTM and ISO)