Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

ASTM F3263-17

Standard Guide for Packaging Test Method Validation

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.

1.3 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.


Content Provider
ASTM International [astm]


Others Also Bought

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607 ...
Integrating human factors into design controls
Post-market surveillance of use error management
Document History
We have no document history for this standard.
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS