4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical materials research and development of UHMWPE materials used in components of implantable orthopedic and spinal joint implant devices that are intended to replace a musculoskeletal joint.

4.2 This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a final, finished product component.

4.3 Assessments of physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials and components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to human conditions. UHMWPE publications can be found in the References section at the end of this guide for further information.

1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) used in components of implantable orthopedic and spinal joint implant devices that are intended to replace a musculoskeletal joint. UHMWPE is used in components of knee, hip, shoulder, elbow, ankle, toe, finger, wrist, and spinal (e.g., vertebral body total disc replacement) joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.

1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.

1.3 This guide does not define all of the assessment methods associated with UHMWPE used in components of orthopedic and spinal joint implant devices.

1.4 This guide does not define all of the preclinical functional tests associated with UHMWPE components of orthopedic and spinal joint implant devices.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.