Hybrid, combination, and replant materials - Orthopaedic Biomaterials in Research and Practice - page 253

Table 10.1 examples of standards relevant to tissue-engineered

products

Standard Title

ASTM F2027 Standard Guide for Characterization and Testing of Raw or

Starting Biomaterials for Tissue-Engineered Medical
Products

ASTM F2064 Standard Guide for Characterization and Testing of Alginates

as Starting Materials Intended for Use in Biomedical and
Tissue-Engineered Products Application

ASTM F2150 Standard Guide for Characterization and Testing of

Biomaterial Scaffolds Used in Tissue-Engineered Medical
Products

ASTM F2211 Standard Classification for Tissue-Engineered Medical

Products

ASTM F2212 Standard Guide for Characterization of Type I Collagen as

Starting Material for Surgical Implants and Substrates for
Tissue-Engineered Medical Products

ASTM F2312 Standard Terminology Relating to Tissue-Engineered Medical

Products

ASTM F2315 Standard Guide for Immobilization or Encapsulation of Living

Cells or Tissue in Alginate Gels

ASTM F2347 Standard Guide for Characterization and Testing of

Hyaluronan as Starting Materials Intended for Use in
Biomedical and Tissue-Engineered Medical Product
Applications

ASTM F2603 Standard Guide for Interpreting Images of Polymeric Tissue

Scaffolds

ASTM F2383 Standard Guide for Assessment of Adventitious Agents in

Tissue-Engineered Medical Products

ASTM F2386 Standard Guide for Preservation of Tissue-Engineered

Medical Products

ASTM F2450 Standard Guide for Assessing Microstructure of Polymeric

Scaffolds for Use in Tissue-Engineered Medical Products

AAMI/ISO
13022

Tissue-Engineered Medical Products—Application of Risk
Management to Viable Materials of Human Origin Used for
the Production of Medical Products

ASTM F2103 Standard Guide for Characterization and Testing of Chitosan

Salts as Starting Materials Intended for Use in Biomedical
and Tissue-Engineered Medical Product Applications

ASTM F2451 Standard Guide for In Vivo Assessment of Implantable

Devices Intended to Repair or Regenerate Articular Cartilage

ASTM F2149 Standard Test Method for Automated Analyses of Cells—The

Electrical Sensing Zone Method of Enumerating and Sizing
Single-Cell Suspension

ASTM F2739 Standard Guide for Quantitating Cell Viability within

Biomaterial Scaffolds

ASTM F1983 Standard Practice for Assessment of Compatibility of

Absorbable/Resorbable Biomaterials for Implant
Applications