ASTM F 3263 : 2017
Current
The latest, up-to-date edition.
Standard Guide for Packaging Test Method Validation
Hardcopy , PDF
English
15-12-2017
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.
| Committee |
F 02
|
| DocumentType |
Guide
|
| Pages |
14
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
1.1This 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.
1.1.1ILS discussion will focus on writing and interpretation of test method precision statements and on alternative approaches to analyzing and stating the results.
1.2This document provides guidance for defining and developing validations for both variable and attribute data applications.
1.3This 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.
1.4This 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.
1.5This 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 F 2097 : 2010 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM E 177 : 1990 : REV A : R1996 | Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods |
| ASTM E 177 : 2014 : REDLINE | Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods |
| ASTM E 456 : 2002 | Standard Terminology for Relating to Quality and Statistics |
| ASTM E 456 : 2013 : REV A : R2022 | Standard Terminology Relating to Quality and Statistics |
| ASTM E 2782 : 2011 : EDT 1 | Standard Guide for Measurement Systems Analysis (MSA) |
| ASTM E 456 : 2013 : REV A : R2022 : EDT 1 | Standard Terminology Relating to Quality and Statistics |
| ASTM F 2097 : 2014 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM F 2097 : 2016 : REDLINE | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM F 2097 : 2023 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM E 2782 : 2010 | Standard Guide for Measurement Systems Analysis (MSA) |
| ASTM E 691 : 2020 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ASTM F 2097 : 2008 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM E 456 : 2013 : REV A : R2017 : EDT 5 | Standard Terminology Relating to Quality and Statistics |
| ASTM E 2282 : 2023 | Standard Guide for Defining the Test Result of a Test Method |
| ASTM F 2097 : 2016 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM E 2282 : 2013 | Standard Guide for Defining the Test Result of a Test Method |
| ASTM E 691 : 2019 : EDT 1 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
| ASTM E 691 : 2023 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
| ASTM E 2282 : 2003 | Standard Guide for Defining the Test Result of a Test Method |
| ASTM E 691 : 2022 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
| ASTM F 2097 : 2020 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM E 2282 : 2014 : R2019 | Standard Guide for Defining the Test Result of a Test Method |
| ASTM E 691 : 2009 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
| ASTM F 2097 : 2007 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM E 2282 : 2014 : R2023 | Standard Guide for Defining the Test Result of a Test Method |
| ASTM E 2782 : 2017 : R2022 | Standard Guide for Measurement Systems Analysis (MSA) |
| ASTM E 2782 :2011 | Standard Guide for Measurement Systems Analysis (MSA) |
| ASTM E 2782 : 2017 : R2022 : EDT 1 | Standard Guide for Measurement Systems Analysis (MSA) |
| ASTM E 691 : 2021 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
| ASTM E 2282 : 2014 | Standard Guide for Defining the Test Result of a Test Method |
| ASTM E 2782 : 2017 | Standard Guide for Measurement Systems Analysis (MSA) |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ASTM E 2282 : 2009 | Standard Guide for Defining the Test Result of a Test Method |
| ASTM F 2097 : 2001 | Standard Guide for Design and Evaluation of Primary Packaging for Medical Products |
| ASTM E 2782 : 2017 : REDLINE | Standard Guide for Measurement Systems Analysis (MSA) |
| ASTM E 456 : 2013 : REV A : R2017 : EDT 4 | Standard Terminology Relating to Quality and Statistics |
| ASTM E 456 : 2013 : REV A : R2017 : EDT 6 | Standard Terminology Relating to Quality and Statistics |
| ASTM F 2097 : 2005 | Standard Guide for Design and Evaluation of Primary Packaging for Medical Products |
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