• ASTM D 6355 : 2007 : R2017

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Human Repeat Insult Patch Testing of Medical Gloves

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-07-2022

    Language(s):  English

    Published date:  17-07-2017

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 09.02, 2017 Describes the potential of glove materials under test to induce and elicit Type 4 skin sensitization reactions (that is, allergic contact dermatitis) in humans.

    Scope - (Show below) - (Hide below)

    1.1This test method is designed to evaluate the potential of glove materials under test to induce and elicit Type IV skin sensitization reactions (that is, allergic contact dermatitis) in humans.

    1.2This test method should be used by individuals experienced in or under the supervision of those experienced in the use of good clinical practice procedures.

    1.3During the performance of the Human Repeat Insult Patch Test (RIPT) for determining sensitization, investigators are confronted with skin responses that represent skin irritation (non-immunologic responses) or allergic contact dermatitis (ACD). The numerical scoring system for grading the intensity of both are similar and test facilities may vary in their scores that describe intensities of allergic and irritant skin responses. The hallmark of a mild allergic contact dermatitis is a sustained palpable erythematous reaction. Delayed-type allergic contact reactions from patch tests have intensity characteristics that favor scores of higher values for longer periods of time and typically do not produce a minimal score (score of 1, a just-perceptible erythema) for short durations (less than 48 h). It is the responsibility of the investigator to evaluate the scores in light of irritant reactions so that the responses are allergic in nature and not irritant. The investigator should denote a final score as either due to contact allergy or irritation. Paragraphs 9.5 – 9.5.5 describe a commonly used scoring system and discuss allergic and irritant responses in detail.

    1.4The Draize RIPT was published in 1944 as an attempt to decrease the frequency ACD.2 The test techniques at that time were just being validated and this experimental design was largely empiric.3 The principle of the test is as follows:

    1.4.1Multiple inductions of the study material at relatively non or low irritancy levels,

    1.4.2Approximately a two-week rest period, and

    1.4.3A standard diagnostic challenge of approximately 48 h and a delayed reading at approximately 96 h after patch application.

    1.5In the intervening years, with further experimentation added to this empiric approach, three additional principles have been learned:

    1.5.1Increasing the concentration of the study material,

    1.5.2Defining a no effect level (this is possible with only individual ingredients and not the final study material), and

    1.5.3The enhanced sensitivity and the use of occlusion (where occlusion would not ordinarily be present).

    1.6In 1945, Henderson and Riley4 demonstrated that a test panel sample size of 30 000 subjects would have to be employed to ensure statistically that there would be no more than 0.1 % sensitization. If there are no allergic responses in a test panel of 200 subjects with exposures comparable to those of the population, then there could be as many as 1.5 allergic reactions per 100 users.

    1.7All medical devices must be safe and effective for their intended use. Since medical devices such as gloves come in contact with human tissue, they should be tested for biocompatibility in animals first. The human repeat insult patch test (RIPT) is one test that can be used to test rubber gloves for skin sensitization to chemicals used in the manufacture of gloves.

    1.7.1Since various forms of the RIPT exist, a single standardized test method that outlines the testing protocol, scoring system, and the criteria for skin sensitization should be developed.

    1.8This 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.

    1.9This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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

    Committee D 11
    Development Note Supersedes ASTM PS 77. (12/2001)
    Document Type Test Method
    Product Note Reconfirmed 2017
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ASTM D 7103 : 2019 Standard Guide for Assessment of Medical Gloves
    ASTM D 6977 : 2019 Standard Specification for Polychloroprene Examination Gloves for Medical Application
    ASTM F 2808 : 2017 Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
    ASTM D 6977 : 2004 : R2016 Standard Specification for Polychloroprene Examination Gloves for Medical Application
    ASTM D 7558 : 2009 : R2019 Standard Test Method for Colorimetric/Spectrophotometric Procedure to Quantify Extractable Chemical Dialkyldithiocarbamate, Thiuram, and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Gloves
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