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ISO 9001:2001 Material Certifications


ERPI certifies that the materials used are in conformance with manufacturer specifications.



Black ULTEM® Rod and Pellets 

Material Description:
Polyethermide (PEI) ULTEM® 
Type 1000F-7101

FDA Specifications: 
USP Class VI 
FDA (21 CFR 177.1595)



Blue ULTEM® Rod and Pellets 

Material Description:
Polyethermide (PEI) ULTEM®
Type 1000F-BL3A507F

FDA Specifications: 
USP Class VI
FDA (21 CFR 177.1595)



DYNAFLEX® G2706-1000-0 Thermoplastic Elastomer Compound

Material Description:
DYNAFLEX®
Type G2706-1000-0

FDA Specifications: 
OSHA (29 CFR 1910.1200)
Does Not Contain Any Hazardous Ingredients



KRATON™ G-2705 Thermoplastic Rubber

Material Description:
KRATON™
Type G-2705

FDA Specifications: 
OSHA (29 CFR 1910.1200)
Does Not Contain Any Hazardous Ingredients



Endoscopy Replacement Parts, Inc. (ERPI), certifies that Ultem® resins in all grades, colors and physical forms, which we recommend and sell for medical device applications, comply with the applicable provisions of the U.S. Food, Drug and Cosmetic Act. This compliance application is specific to Ultem® 1000F-7101 resins. This is the type used in all Ultem® based products produced and sold by ERPI.

Typical lots of Ultem® resin have been subjected to the battery of biological tests specified by the United States Pharmacopeia (USP) Class VI (121°C) requirements for plastics. Additionally, these same resins have been tested and passed FDA Tripartite Guidelines and ISO10993-1 modified matrix for medical devices which include biological tests such as, but not limited to:
  1. Acute Systemic Toxicity Test
  2. Intra-coetaneous Toxicity Test
  3. Implantation Test
  4. Cytotoxicity Test
  5. Hemolysis Test
  6. Ames Mutagenicity Test
  7. Pyrogenicity Test
  8. Sensitization Test
  9. Sub-Chronic Toxicity Test
     a. Fourteen day implantation test with Histopathology test