Spacers and holding chambers for use with metered-dose inhalers
This is the first edition of CSA Z264.1, Spacers and Holding Chambers for Use with Metered-Dose Inhalers.
The purpose of the Standard is to help ensure effective delivery of medication to the patient when spacers and/or holding chambers are used in conjunction with metered-dose inhalers. Delivery of medication is dependent on the design, performance, and durability of these devices and on the skill and knowledge of the patient. This Standard specifies requirements for the design, testing, and labelling of spacers and/or holding chambers.
This Standard was prepared by the Subcommittee on Inhalant Aerosol Drug Delivery Systems, under the jurisdiction of the Technical Committee on Drug-Related Standards and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. It will be submitted to the Standards Council of Canada for approval as a National Standard of Canada.
This Standard sets out requirements for spacers and/or holding chambers (S-HCs) for use with pressurized metered-dose inhalers. It stipulates the material and components, the packaging and labelling, and aerosol characterization as determined by in vitro testing.
This Standard does not address
(a) pressurized metered-dose inhalers (pMDIs) and the medications that are delivered by these units;
(b) S-HCs used with pMDIs in ventilator circuits or artificial airways;
(c) S-HCs for use with dry powder inhalers or nebulizers;
(d) tests of mask fit in S-HCs that are supplied with a mask;
(e) products that combine a pMDI and an integrated, usually non-detachable, S-HC in the same unit; and
Note: These products are covered by Canadian regulations governing pharmaceuticals.
(f) the clinical effects and efficacy of medications when used in conjunction with S-HCs.
Note: Clinical studies and professional literature should be consulted for information on the efficacy and long-term effects of the medications themselves.
This Standard does not address the interface between the S-HC and the pMDI canister on spacers and/or holding chambers with integral actuators.
Note: It is expected that an S-HC with an integral actuator will meet the requirements of this Standard.
In CSA Standards, “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.
Legends to equations and figures are considered requirements.