Work Item
ASTM WK69860

New Test Method for the Determination of the Sample Size to Use in Testing Medical Devices

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

Keywords

medical devices, sample size

Rationale

In the Spring of 2019, a version of this document was balloted as part of a revision to F1378 (Total Shoulder Specification). At the Spring, 2019 F04.22 meeting, we decided that it was best to have a separate document to help determine the sample size for the testing of arthroplasty devices. It was therefore extracted from the previously proposed revision of F1378. For the Spring, 2019 ballot, there were 2 negatives and 4 comments. The negative from John Goode was determined to be persuasive. The below includes many of the suggested changes from the negatives and comments and will be balloted at the subcommittee level. If accepted, individual arthroplasty specifications could then be modified to reference this test method. In the future this test method could be used by other subcommittees.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: F04.22

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 09-10-2019

Technical Contact: Frederick Werner

Item: 001

Ballot: F04.22 (19-05)

Status: Will Reballot Item

Item: 022

Ballot: F04 (20-02)

Status: Will Reballot Item

Item: 006

Ballot: F04 (21-02)

Status: Will Reballot Item

Item: 009

Ballot: F04 (21-08)

Status: Negative Votes Need Resolution