1.1 The purpose of this specification is to provide a test procedure and performance requirement for the puncture resistance of materials used in the construction of containers for discarded medical needles and other sharps. This test specification will establish (1) the average puncture force and (2) a minimum value of puncture force that container material(s) must withstand when following the test procedure described in Section 6. This specification shall be applicable to regions of uniform material and thickness, and needle contact areas as defined in 3.1.7 and 3.1.9. Materials meeting the performance requirements of Section 4 will be considered “puncture resistant.” This specification will not evaluate the construction of, or provide pass/fail criteria for, a sharps container.

1.2 This specification provides a test procedure to determine if all regions of one container meet the material puncture resistance requirements. It does not define the number of additional test containers required to achieve a statistically valid sample of a manufacturing lot or process. An appropriate sampling plan shall be determined by the test requester, as this depends upon the manufacturing process variability, manufacturing lot size, and other factors, such as end-user requirements.

1.3 This specification 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 (see 6.1). (Warning—This specification only characterizes material puncture resistance at normal room temperatures. Applications of sharps containers outside the range of 23 ± 2°C (beyond the clinical environment, such as usage in emergency vehicles), require further material characterization by the product specifier to determine suitable use.)

1.4 The values stated in inch/pound are to be regarded as the standard. The SI values given in parentheses are for information only.

1.5 The following hazard caveat pertains only to the test procedure portion, Section 6, of this specification.

1.6 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.