ASTM F 2559/F2559M : 2006 : R2010 : EDT 1

Name: ASTM F 2559/F2559M : 2006 : R2010 : EDT 1
Brand: ASTM
Price: 75.00 USD

Superseded

View Superseded by

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Superseded date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

10-01-2010

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 15.09, 2016 Describes 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 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

1.6 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
DevelopmentNote	Supersedes ASTM F 2559. (12/2010)
DocumentType	Guide
Pages	6
ProductNote	Reconfirmed EDT 1
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 2559/F2559M : 2006 : R2015
Supersedes	ASTM F 2559 : 2006

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