ASTM-F2559 2006

$40.63

F2559-06 Standard Guide for Writing a Specification for Sterilizable Peel Pouches

Published By	Publication Date	Number of Pages
ASTM	2006	6

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Categories: 11.120.99 - Other standards related to pharmaceutics, ASTM

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Description

ASTM F2559-06

Historical Standard: Standard Guide for Writing a Specification for Sterilizable Peel Pouches

ASTM F2559

Scope

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.

Keywords

chevron pouch; corner peel pouch; header bag; peel pouch; specification

ICS Code

ICS Number Code 11.120.99 (Other standards related to pharmaceutics)

DOI: 10.1520/F2559-06

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology Summary Significance and Use
2	Specification FIG. 1 FIG. 2
3	FIG. 3
4	TABLE 1
5	Keywords

Additional information

Standard Title	F2559-06 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Published Code	ASTM
Publication Date	2006
Pages Count	6
ICS Codes	11.120.99 - Other standards related to pharmaceutics