CSA Z314.10.1-15

Preface

This is the second edition of CSA Z314.10.1, Selection and use of gowns and drapes intended for use in health care settings. It supersedes the previous edition published in 2010. It is one of the CSA Z314 series of Standards dealing with decontamination, disinfection, and sterilization.

This Standard has been revised to work in tandem with applicable requirements of CSA Z314.0, Medical device reprocessing – General requirements, CSA Z314.10.2, Laundering, maintenance, and preparation of reusable gowns, drapes, and wrappers in health care settings, and other standards in the CSA Z314 series.

The selection and use of wrappers, covered by previous editions of this Standard, is now addressed by CSA Z314.14, Selection and use of packaging (sterile barrier systems) in health care settings. The laundering of wrappers, however, is still addressed by CSA Z314.10.2.

Introduction

Gowns and drapes are important elements of infection prevention and control programs within health care settings. The safety of patients and staff depends on the correct choice of products for each purpose, and on the maintenance of the products’ protective qualities through proper use and care. Misuse significantly decreases the protective qualities of gowns and drapes, thereby increasing the risk posed to patients and staff, as well as increasing costs.

This Standard specifies requirements for the selection and use of reusable and single-use gowns and drapes and provides this information for health care settings and their laundries, whether in-house or outsourced. It is intended to ensure the safety and serviceability of surgical gowns, isolation gowns, and drapes, and to promote safe infection prevention and control practices for the protection of patients and health care personnel.

This Standard is intended to be used with CSA Z314.14, CSA Z314.10.2 and relevant aspects of CSA Z314.0, and other standards in the CSA Z314 series.

Scope

1.1

This Standard defines essential elements in the selection and use of gowns and drapes in health care settings and laundry services. Included in the selection criteria are minimum construction and performance requirements for gowns and drapes, to help health care settings choose products with barrier qualities that are appropriate for their intended use.

1.2

This Standard specifies requirements for the following areas:

a) responsibilities of the health care setting’s and laundry service’s administration;

b) policies and procedures relating to the selection and use of gowns and drapes;

c) quality systems and documentation;

d) qualifications for personnel who handle new, laundered, and soiled gowns and drapes;

e) basic characteristics and classification of, and selection criteria for, gowns and drapes;

f) storage, transportation, and handling of clean and sterile gowns and drapes; and

g) handling of soiled gowns and drapes prior to disposal or laundering.

1.3

This Standard does not cover

a) the maintenance, laundering, and preparation of reusable gowns, and drapes, (See CSA Z314.10.2); and

b) how to enclose a medical device using a wrapper (See CSA Z314.14).

Note: A wrapper performing as a sterile barrier system is addressed by CSA Z314.14.

1.4

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.

1.5

The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only.