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.
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