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ASTM F 3263 : 2017

Current

Current

The latest, up-to-date edition.

Standard Guide for Packaging Test Method Validation

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-12-2017

€61.92
Excluding VAT

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.

AAMI/ISO TIR16775:2023 Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

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 E 2782 : 2024 Standard Guide for Measurement Systems Analysis (MSA)
ASTM F 2097 : 2005 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products

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