1. Scope 1.1
This Standard applies to the material of construction, the physical integrity, and the labelling requirements of biohazardous and cytotoxic medical sharps containers. 1.2
This Standard applies to medical sharps containers intended for single use. 1.3
This Standard states test criteria for the evaluation of the following characteristics of sharps containers: (a) puncture resistance;
(b) thermal integrity during exposure to high temperature steam sterilization;
(c) colour-coding, labelling, and symbols;
(d) fill capacity; and
(e) physical integrity of containment.
Specific test criteria for cytotoxic sharps containers are included. 1.4
This Standard does not apply to medical sharps containers that are intended for sharps contaminated with chemicals with no possibility for any biohazardous or cytotoxic contamination. However, for the purpose of safe management of chemically contaminated or clean sharps, this Standard may be used for reference testing and as a general guide. 1.5
This Standard does not address deliberate or accidental access to sharps within containers. This aspect of safety and security should be considered when the containers are selected for use in noncontrolled environments. 1.6
In this Standard, 'shall' indicates a mandatory requirement; 'should' indicates a recommendation, or that which is advised but not mandatory. Notes accompanying clauses do not include mandatory or alternate requirements. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered to be part of the figure or table and are written as mandatory requirements.