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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    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    Superseded date:  11-11-2014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:  10-07-1998

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee F 02
    Document Type Test Method
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    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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