Selection and use of packaging (sterile barrier systems) in healthcare settings
|Publication Date:||1 January 2015|
This Standard defines essential elements for the evaluation, selection, inspection, and proper use of preformed sterile barrier systems, sterile barrier systems, and packaging systems. The selection criteria include minimum performance requirements to help healthcare settings choose products that are appropriate for their intended use.
This Standard applies to the following
a) reusable sterilization container systems including trays and cassettes intended for use in sterilization processes that do not rely on wrapping;
b) sterilization wraps including
i) reusable textile sterilization wrap; and
ii) disposable sterilization wrap; and
c) sealable sterilization pouches and rolls. In addition this Standard addresses items intended to facilitate aseptic presentation such as protective organizing cases or trays that require additional wrapping or an additional method of containment for sterilization and maintenance of sterility.
This Standard sets forth requirements in the following areas:
a) policies and procedures related to the use of packaging;
b) general characteristics, selection, and purchasing of packaging;
c) evaluation of the design, performance, and labelling of packaging;
d) matching of packaging to appropriate sterilization methods and cycles;
e) testing prior to use;
i) preparation, and assembly of packaging including wrapping methods;
ii) infection prevention and control; and
iii) aseptic presentation and use; and f) quality assurance.
This Standard does not provide requirements for
a) ongoing sterility assurance programs in healthcare settings;
b) textile gowns and packs;
c) laundering and maintenance of reusable sterilization gowns and wraps;
d) sterilizer loading and unloading; and
e) use of packaging materials after opening, for other purposes (e.g. sterile fields, transport of contaminated items).
Note: CSA Z314.0 provides requirements for quality management systems. CSA Z314.3 and CSA Z314.23 provide requirements for steam sterilization and chemical sterilization in healthcare settings. CSA Z314.10.1 provides requirements for the selection and use of sterilization gowns and drapes. CSA Z314.10.2 provides requirements for laundering of reusable surgical textiles. CSA Z314.15 provided requirements for, storage, handling, and transportation of single use and reusable medical devices.
In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the Standard.
Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.
Notes to tables and figures are considered part of the table or figure and may be written as requirements.
Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.