ANSI - American National Standards Institute
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Voluntary Standards Cover the Spectrum: from Shipping Containers to Packaging in Healthcare Settings


08/30/2016

In an effort to communicate the vital role that standards play in daily life, the American National Standards Institute (ANSI) publishes snapshots of the diverse standards initiatives undertaken in the global and national standards arena, many of which are performed by ANSI members and ANSI-accredited standards developers. Two of the latest selections follow:

Performance Testing of Shipping Containers and Systems

Businesses across the supply chain regularly depend on shipping containers for intermodal product and cargo transports to their customers, without the risk of damage or loss to their goods. As shipping container utilization continues to make an impact and even alter the dynamics of globalization, standardization for performance testing of shipping containers and systems remains a necessity.

An American National Standard (ANS) from ANSI member and audited designator ASTM International, ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems, provides a uniform basis of evaluating, in a laboratory, the ability of shipping units to withstand the distribution environment. This is accomplished by subjecting the shipping units to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles, though the practice is not intended to supplant material specifications or existing preshipment test procedures.

ASTM International seeks to develop voluntary consensus standards to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence.

Selection and Use of Packaging (Sterile Barrier Systems) in Healthcare Settings

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.

Keywords

AN INTRODUCTION TO STANDARDS: WHY, WHERE AND HOW ARE THEY DEVELOPED?