ASTM F2132-01 Standard Specification for Puncture Resistance of Materials Used in Containers for Waste Medical Needles and Other Sharp Instruments

The standard "ASTM F2132-01 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps" developed by the American Society for Testing and Materials (ASTM) describes a test procedure and performance requirements for the puncture resistance of materials used in the construction of containers for discarded medical needles and other sharp objects. This test specification determines the average puncture force and the minimum puncture force that container materials must withstand when following the described test procedure. This specification applies to areas of uniform material and thickness and to needle contact areas.

Materials that meet the performance requirements of this standard are considered puncture resistant. This specification does not evaluate the construction of a sharps container or provide pass/fail criteria.

This specification defines a test procedure to determine whether all areas of a container meet material puncture resistance requirements. It does not define the number of additional test containers required to obtain a statistically valid sample of a production batch or process. An appropriate sampling plan is determined by the test requester because it depends on manufacturing process variability, production batch size, and other factors such as end-user requirements.

This standard is intended to evaluate the performance of materials used in the construction or manufacture of sharps containers under controlled laboratory conditions and at normal room temperature. This standard characterizes the puncture resistance of the material at normal room temperatures only. Applications of sharps containers outside the 23 degree plus/minus 2 degree range (beyond the clinical environment, such as use in emergency vehicles) require further material characterization by the product specifier to determine appropriate use.

For the purposes of this standard, the following terms and definitions apply:

• A container is a product used to hold discarded medical needles and other sharp objects.
• Materials are the substances used in the construction of containers in which sharp objects are placed.
• Penetration force is the minimum force applied to a representative sharp object that will cause its tip to penetrate (exit) the test specimen from the side on which it entered, to the opposite side when tested in accordance with this standard.
• A puncture resistant, uniform material and thickness zone is defined as puncture resistant if it conforms to this standard when tested in accordance with this standard.
• The test sample is a sample of puncture-resistant material taken from the actual container (direct method) or a representative sample of material and thickness having the same properties as the actual container (indirect method).
• A puncture test specimen is a test specimen that has been punctured using the puncture test described in this standard and subsequently evaluated using the direct or indirect methods described in this specification.
• The uniform material and thickness zone is the sharp contact areas of the container that are made of the same homogeneous, composite or laminated material and are expected to have the same material and thickness compared to other areas of the container, as a result of manufacturing or design or both.
• Sharps are items used in medical treatment, diagnosis or research that can cause puncture wounds, cuts or lacerations to the skin or mucous membranes (including, but not limited to, hypodermic, surgical, suture and IV needles, Pasteur pipettes, lancets, razor blades, scalpels and other blades and sharp objects).
• Sharps contact areas are the material of a container that represents the surfaces surrounding sharps inside the container in its final closure configuration (i.e., disposal configuration).

When tested in accordance with this standard, the average penetration force to penetrate material test specimens representing regions of uniform material and thickness and areas of contact with sharp objects, as defined, shall not be less than 15 N and no value from any region of the material tested shall be less than 12,5 N.

If a container is designed to use layers of non-laminated material in areas that come into contact with sharp objects, the combination of these layered materials shall be tested as configured in actual use and shall meet the puncture resistance specification of this standard to be considered puncture resistant. If a container is designed to use a removable liner surrounded by the container, the material used inside the removable liner shall meet the puncture resistance specification of this standard to be considered puncture resistant. For example, layered materials shall be tested with the same range as configured in actual use.

Our organization has a strong staff that closely follows the developments in the world in the field of science and technology and constantly improves itself. Among the numerous test, measurement, analysis and evaluation studies provided for businesses in various sectors, there are also test services in accordance with the standard "ASTM F2132-01 Standard specification for puncture resistance of materials used in containers for waste medical needles and other sharp instruments".