Historical
CSA Z314.14-2015
Z314.14-15 - Selection and use of packaging (sterile barrier systems) in healthcare settings
Preface
This is the fifth edition of CSA Z314.14, Selection and use of packaging (sterile barrier systems) in healthcare settings. It supersedes the previous editions published in 2010, 2004, and 1993 under the title, Selection and use of sterilization containers. It is one of the CSA Z314 series of Standards addressing quality systems, decontamination, disinfection, packaging, sterilization, and storage. This Standard specifies requirements for the effective use of sterile barrier systems, including wrappers, and includes selection criteria for healthcare settings to use when purchasing these medical devices. This Standard has been revised to work in tandem with applicable requirements of CSA Z314.0, Medical device reprocessing - General requirements, and other standards in the CSA Z314 series.Introduction
Medical devices are used in every medical procedure. Patients and healthcare professionals expect these medical devices to be safe. The safety of medical devices begins with the manufacturer and is supported by a system of national standards and government regulations that includes medical device licensing, construction and performance standards, and problem reporting systems. These systems serve as a guide for healthcare facilities and users to ensure proper care and handling is achieved every time a medical device is used. Within this structure there are, departments, clinics, and offices located on and off site that reprocess medical devices. These areas play an essential role and face unique challenges. Unlike the medical device manufacturer, medical device reprocessing personnel work with a wide array of medical devices manufactured by different companies, these medical devices are received in varying states of cleanliness and repair. It is the responsibility of the medical device reprocessing department (MDRD) to develop standard operating procedures that provide for each step of the cleaning, inspection, and functionality testing, followed by disinfection or sterilization for each medical device. These standard operating procedures are developed using the device manufacturer's validated written instruction for reprocessing a reusable medical device. The goal is to provide medical devices that perform as intended by the manufacturer and are safe for reuse. Packaging is a vital step in reprocessing. The user requires knowledge of the quality and type of packaging required to maintain the sterility of medical devices. Packaging is available in many types and this Standard will address the types, quality and wrapping techniques. This Standard is one of a series of standards to be used in conjunction with CSA Z314.0, Medical device reprocessing - General requirements, which provides a framework to establish, document, and maintain requirements for the reprocessing of medical devices as part of a quality management system. This Standard is intended to provide comprehensive requirements for the safe and reliable packaging of reusable medical devices.Scope
1.1 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. 1.2 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
- i) preparation, and assembly of packaging including wrapping methods; ii) infection prevention and control; and iii) aseptic presentation and use; and
Content Provider
CSA America, Inc. [csa]
