Name: ASTM F 1886 : 1998
Brand: ASTM
Price: 66.00 USD

ASTM F 1886 : 1998

Superseded

View Superseded by

Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

07-10-1998

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 15.09, 2009 Covers the determination of channels in the package seal down to a width of 75 micrometer (0.003 in.) with a 60 - 100 % probability.

1.1 this test method covers the determination of channels in the package seal down to a width of 75 um (0.003 in.) with a 60-100% probability (see Section 8).

1.1.1 The ability to visually detect channel defects in package seals is highly dependent on the size of channel, the degree of contrast from sealed and unsealed areas, the amount and type of adhesive between the two package layers, reflecting light angle, types of material used, the use of magnification, an the inspector's level of training and experience.

1.2 This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.

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

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

Committee	F 02
DocumentType	Test Method
Pages	4
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 1886 : 1998 : R2004 ASTM F 1886/F1886M : 2016 : REDLINE

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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)
ASTM F 2559/F2559M : 2006 : R2010 : EDT 1	Standard Guide for Writing a Specification for Sterilizable Peel Pouches
ASTM F 1585 : 2000	Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)
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 2559/F2559M : 2006 : R2015	Standard Guide for Writing a Specification for Sterilizable Peel Pouches
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
ASTM F 2097 : 2016	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products