ASTM F 1886 : 1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
Hardcopy , PDF
11-11-2014
English
10-07-1998
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.
Committee |
F 02
|
DocumentType |
Test Method
|
Pages |
4
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy |
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.
ASTM F 2559 : 2006 | Standard Guide for Writing a Specification for Sterilizable Peel Pouches |
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) |
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ASTM F 1585 : 2000 | Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006) |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 |
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