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ASTM F 1929 : 2015 : REDLINE

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Available format(s)

PDF

Superseded date

12-26-2023

Language(s)

English

Published date

12-18-2015

CONTAINED IN VOL. 15.09, 2016 Describes materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 [mu]m (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material.

1.1This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.

1.2Three dye application methods are covered in this test method: injection, edge dip, and eyedropper.

1.3These test methods are intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.

1.4These test methods require that the dye penetrant solution have good contrast to the opaque packaging material.

1.5The values are stated in International System of Units (SI units) and English units. Either is to be regarded as standard.

1.6This 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
Redline
Pages
6
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

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 D 7160 : 2016 : REDLINE Standard Practice for Determination of Expiration Dating for Medical Gloves
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
ANSI Z80.7 : 2013 OPHTHALMIC OPTICS - INTRAOCULAR LENSES
AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
DIN EN ISO 11979-6:2015-02 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
DIN EN ISO 11979-6 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
I.S. EN ISO 11979-6:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
UNI EN ISO 11979-6 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING
I.S. EN 13503-6:2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
05/30097406 DC : DRAFT JUL 2005 ISO 11979-6 - OPHTHALMIC INSTRUMENTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
ASTM D 7161 : 2016 : REDLINE Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
PREN ISO 11979-6 : DRAFT 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013)
ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
13/30254047 DC : 0 BS EN ISO 11979-6 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
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
BS EN ISO 11979-6:2014 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing
UNE-EN ISO 11979-6:2015 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
EN ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
BS EN 13503-6:2002 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability
EN 13503-6 : 2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY

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