Name: ASTM F 3263 : 2017
Brand: ASTM
Price: 69.00 USD

Standard Guide for Packaging Test Method Validation

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-15-2017

Publisher

American Society for Testing and Materials

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.

1.1This 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.

Committee	F 02
DocumentType	Guide
Pages	14
PublisherName	American Society for Testing and Materials
Status	Current

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ASTM F 2097 : 2016 : REDLINE	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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ASTM E 2782 : 2010	Standard Guide for Measurement Systems Analysis (MSA)
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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