Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

Importancia y uso:

4.1 The purpose of this guide is to provide guidance for selecting appropriate device size(s) and determining appropriate sample size(s) for design verification of endovascular devices. The device size(s) and sample size(s) for each design input requirement should be determined before testing. The device size(s) selected for verification testing should establish that the entire device matrix is able to achieve the design input requirements. If testing is not performed on all device sizes, justification should be provided.

4.2 The sample size justification and statistical procedures used to analyze the data should be based on sound scientific principles and should be suitable for reaching a justifiable conclusion. Insufficient sample size may lead to erroneous conclusions more often than desired.

4.3 Guidance regarding methodologies for determining device size selection and appropriate sample size is provided in Sections 5 and 6.

Subcomité:

F04.30

Referida por:

F3211-17, F3374-19, F3036-21, F3505-21, F2477-24

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

attribute; normality; sample size; sampling plan; statistics; variables; verification;