Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

Importancia y uso:

5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.

5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.

5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions as well as the usual continuous regions of protective clothing items.

5.2 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is approximately 42 to 60 dyn/cm (0.042 to 0.060 N/m) (1).7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is approximately 40 ± 5 dyn/cm (0.040 ± 0.005 N/m).

5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood.

5.4 Part of the protocol in Procedures A and B in Table 1 for exposing the protective clothing material specimens with synthetic blood involves pressurizing the test cell to 13.8 kPa [2.0 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and to correlate with visual penetration results that are obtained with a human factors validation (2). Some studies, however, suggest that mechanical pressures exceeding 345 kPa [50 psig] can occur during clinical use (3, 4). Therefore, it is important to understand that this test method does not simulate all the physical stresses and pressures that are exerted on protective clothing garments during actual use. This test method is offered to identify those protective clothing materials that warrant further evaluation with a microbiological challenge.

5.5 Since this test method uses visual observation rather than analytical measurements to determine penetration, use this test method as a preliminary evaluation for possible penetration of blood and other body fluids. Perform subsequent testing with a microbiological challenge and analytical technique using Test Method F1671/F1671M.

Note 1: No viral resistance claims can be made based on this test method, as materials can pass the test method and fail Test Method F1671/F1671M.

5.6 Testing without considering degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective barrier could lead to a false sense of security. Consider tests which assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the protective barrier can also be compromised during use by such effects as flexing and abrasion (5). It is also possible that prewetting by contaminating materials such as alcohol and perspiration can also compromise the integrity of the protective barrier. If these conditions are of concern, evaluate the performance of protective clothing materials for synthetic blood penetration following an appropriate preconditioning technique representative of the expected conditions of use.

5.7 While this test method involves a qualitative determination of the protective clothing material resistance to penetration by synthetic blood under specific test conditions, it is possible to use this test method as a material quality control or assurance procedure.

5.7.1 If this procedure is used for quality control, perform proper statistical design and analysis of the data when more than three specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested, the average percent passing or failing, or both, with a standard deviation. Data reported in this way helps to establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as MIL-STD-105E, ANSI/ASQC Z1.4, and ISO 2859-1.

Subcomité:

F23.40

Referida por:

F1359_F1359M-22, F1671_F1671M-22, F1862_F1862M-24, F1819-19

Volúmen:

11.03

Número ICS:

11.140 (Hospital equipment), 13.340.10 (Protective clothing)

Palabras clave:

blood; blood-borne pathogens; body fluids; penetration; protective clothing; synthetic blood;