ISO 16603 Determination of Resistance of Protective Clothing Materials to Penetration by Blood and Body Fluids - Test Method Using Synthetic Blood

EUROLAB laboratory provides testing and compliance services within the scope of ISO 16603 standard. The ISO 16603 standard, developed by the International Standards Organization (ISO), describes a laboratory test method for measuring the penetration resistance of clothing materials to blood and body fluids. This test method uses a synthetic blood that is in constant contact with the material sample under certain conditions using the ISO 13994 test apparatus.

This test method is not always effective for testing protective clothing materials with thick, inner linings that readily absorb synthetic blood.

Persons involved in the treatment and care of injured or sick individuals, especially healthcare professionals, may be exposed to infectious biological fluids. These diseases, which can be caused by various microorganisms, can pose significant risks to life and health. This is especially true for blood-borne viruses that cause hepatitis [hepatitis B virus (HBV) and hepatitis C virus (HCV)] and acquired immune deficiency syndrome (AIDS) [human immunodeficiency viruses (HIV)]. Consideration is given to reducing the potential for direct skin contact through the use of protective clothing, as engineering controls cannot eliminate all possible exposures.

This International Standard deals with protective clothing and associated protective devices designed to protect against the ingress of blood or bodily fluids. This test method only considers the performance of materials used in protective clothing or of certain material structures (eg seams). This test method does not consider the design, overall construction and components or interfaces of the garments or other factors that may affect the overall protection afforded by the protective clothing.

It is emphasized that the test does not have to simulate the conditions that clothing materials are likely to be exposed to in practice. Therefore, the use of test data should be limited to broad comparative evaluation of such materials based on their synthetic blood penetration resistance properties. Testing before the protective barrier is deteriorated by physical, chemical and thermal stresses that can adversely affect its performance can lead to a false sense of security. Tests that evaluate the effect of storage conditions and shelf life on penetration resistance for disposable products and the effects of washing and sterilization on penetration resistance for reusable products should be considered.

The integrity of the protective barrier can be compromised by effects such as stretching and abrasion during use, or by effects such as pre-wetting by pollutants such as alcohol and perspiration. If these conditions are the case, the performance of protective clothing materials for synthetic blood penetration should be evaluated following an appropriate preconditioning technique that represents the expected conditions of use.

Medical protective clothing materials are intended to be a barrier against blood, body fluids and other potentially infectious materials. Many factors can affect the wetting and penetration properties of body fluids, such as surface tension, viscosity and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of materials. The surface tension range for blood and body fluids (excluding saliva) is about 0,042 N/m to 0,060 N/m. To help simulate the wetting properties of blood and body fluids, the surface tension of synthetic blood is adjusted approximately to the lower end of this surface tension range, ie (0,042 ± 0,002) N/m.

Part of this method of exposing protective clothing material samples to synthetic blood involves pressurizing the test cell to 14,0 kPa (in Procedures A and B). This hydrostatic pressure has been documented to produce test results associated with human factors verification. However, some research suggests that mechanical pressures in excess of 345 kPa can occur during actual use. Therefore, it is important to understand that this test method does not simulate all the physical stresses and pressures applied to protective clothing during use.

This test method can also be used as a screening test to determine what time and pressure protocol is appropriate to evaluate the viral resistance properties of protective clothing with a more sophisticated barrier test method as described in ISO 16604. Procedures C and D, a stepwise pressurization approach with pressures up to 20,0 kPa. These procedures simulate a range of possible procedures to rank material performance.

Given the diversity of healthcare environments, activities, and potential for exposure to blood or body fluids, barrier requirements for protective clothing materials will change with application. The choice of an appropriate test method depends on the specific application and intended use of the protective clothing. A risk assessment should be performed to determine the level of risk to determine the appropriate testing method.

Among the services provided by our organization within the framework of material testing services, there are also ISO 16603 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.