ASTM F3263-17
Standard Guide for Packaging Test Method Validation

Standard No.

ASTM F3263-17

Release Date

2017

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3263-17

Scope

1.1 This guide provides information to clarify the process of validating packaging test methods specific for an organization utilizing them as well as through inter-laboratory studies (ILS), addressing consensus standards with inter-laboratory studies (ILS) and methods specific to an organization. 1.1.1 ILS discussion will focus on writing and interpretation of test method precision statements and on alternative approaches to analyzing and stating the results. 1.2 This document provides guidance for defining and developing validations for both variable and attribute data applications. 1 This test method is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design and Development. Current edition approved Dec. 15, 2017. Published March 2018. DOI: 10.1520/ F3263–17. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 1.3 This guide provides limited statistical guidance; however, this document does not purport to give concrete sample sizes for all packaging types and test methods. Emphasis is on statistical techniques effectively contained in reference documents already developed by ASTM and other organizations. 1.4 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. 1.5 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.

ASTM F3263-17 Referenced Document

• ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• ASTM E2282 Standard Guide for Defining the Test Result of a Test Method*， 2023-11-01 Update
• ASTM E2782 Standard Guide for Measurement Systems Analysis (MSA)*， 2022-05-15 Update
• ASTM E456 Standard Terminology for Relating to Quality and Statistics
• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• ASTM F17 Standard Terminology Relating to Flexible Barrier Materials
• ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products*， 2023-10-01 Update
• ISO/TS 16775 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2*， 2021-10-31 Update

ASTM F3263-17 history

• 2017 ASTM F3263-17 Standard Guide for Packaging Test Method Validation