Name: ASTM F 2096 : 2011
Brand: ASTM
Price: 75.00 USD

ASTM F 2096 : 2011

Superseded

View Superseded by

Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

Available format(s)

Hardcopy , PDF

Superseded date

02-19-2020

Language(s)

English

Published date

12-15-2011

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 15.10, 2015 Defines the detection of gross leaks in packaging. Method sensitivity is down to 250 [mu]m (0.010 in.) with an 81% probability.

1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.

1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.

1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure

1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

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	Test Method
Pages	5
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 2096 : 2011 : R2019
Supersedes	ASTM F 2096 : 2004

ASTM F 2097 : 2016	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
S.R. CEN ISO/TS 16775:2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
CAN/CSA-ISO/TS 16775:17	Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
CEN ISO/TS 16775:2014	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
PD CEN 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 : 2016 : REDLINE	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ANSI/AAMI/ISO TIR16775:2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
ISO/TS 16775:2014	Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
UNI CEN ISO/TS 16775 : 2014	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2