Patients undergo a range of medical procedures on a daily basis and the safety of these entrusted medical devices is essential. Packaging to maintain the sterility is one clear way to communicate the safety of equipment and instruments.
An ANS developed by CSA Group serves to address packaging types, quality, and wrapping techniques: CSA Z314.14-2015, Selection and use of packaging (sterile barrier systems) in healthcare settings. 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 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.
The standard is one of a series of standards to be used in conjunction with CSA Z314.14-2015, Medical device reprocessing - General requirements, which provide a framework to establish, document, and maintain requirements for the reprocessing of medical devices as part of a quality management system. The ANS is intended to provide comprehensive requirements for the safe and reliable packaging of reusable medical devices.
CSA Group, an ANSI member and accredited standards developer, is a non-profit membership association dedicated to safety, social good, and sustainability through standards development, training, global testing, consumer product evaluation services, and certification services covering industries such as plumbing, construction, medical, safety, technology, appliances, gas, alternative energy, and lighting.