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ASTM F 2559 : 2006

ASTM F 2559 : 2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Writing a Specification for Sterilizable Peel Pouches

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

11-01-2006

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 15.09, 2009 Defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices.

1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.

1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.

1.3 Pouch materials may be either porous, nonporous, or any combination of the two.

1.4 This guide addresses some critical printing requirements on the pouch.

1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.

Committee
F 02
DocumentType
Guide
Pages
6
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
ASTM F 2097 : 2016 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 99 : 2007 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
ASTM F 99 : 2007 : R2011 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
ASTM F 99 : 2007 : R2015 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials

ASTM E 122 : 2017 : REDLINE Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
ASTM F 2475 : 2011 : REDLINE Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F 1886 : 1998 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

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Hardcopy - English
PDF - English
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