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ASTM F 3037 : 2015

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
Available format(s)

Hardcopy , PDF

Withdrawn date

06-22-2020

Language(s)

English

Published date

06-01-2015

CONTAINED IN VOL. 13.02, 2015 Specisifies a resource for individuals and organizations involved in designing clinical trials of hip replacement systems (HRSs) including metal/polymer, metal/ metal, metal/composite, metal/ceramic/polymer, metal/polymer/metal, and ceramic/ceramic bearing surfaces; semiconstrained and constrained designs; and cemented, nonporous uncemented, and porous-coated uncemented fixation.

1.1This guide is intended as a resource for individuals and organizations involved in designing clinical trials of hip replacement systems (HRSs) including metal/polymer, metal/metal, metal/composite, metal/ceramic/polymer, metal/polymer/metal, and ceramic/ceramic bearing surfaces; semi-constrained and constrained designs; and cemented, nonporous uncemented, and porous-coated uncemented fixation.

1.2In this guide, methods to measure the efficacy, effectiveness, and safety of HRS devices through standardizing outcomes measures are provided for designing, reviewing, and accepting human clinical trial protocols.

1.3This guide is intended to provide consistency in study design, review, regulatory approval, and coverage approval for hip replacement systems to the health care market.

1.4For the purpose of this guide, an HRS is any device that is intended to replace the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term functional restoration and pain relief without major adverse events are the desired outcomes.

1.5This 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 and health practices and determine the applicability of regulatory limitations prior to use.

Committee
F 04
DocumentType
Guide
Pages
7
PublisherName
American Society for Testing and Materials
Status
Withdrawn

ASTM F 561 : 2013 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ASTM F 2809 : 2010 Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
ASTM F 2979 : 2014 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
ISO 12891-2:2014 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
ASTM F 2978 : 2013 Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling

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