New Guide for the Criteria and Classification of Medical Grade Polymers and Polymer Compounds for Non-Implantable Applications
1. Scope
1.1 This Guide provides information for purchasers / specification owners (e.g. Medical Device OEMs) and suppliers (e.g. medical polymer manufacturers) to align expectations of the essential requirements for polymers used in the manufacture of non-implantable medical devices, in vitro diagnostics, and packaging and to create a harmonized understanding of the application of ‘medical grade’ terminology.
1.2 This Guide addresses polymeric materials (potentially referred to as plastic, resin, compound, composite, blends, and others) as a raw or starting material for a wide range of non-implantable medical applications within the medical device industry but excludes any implantable applications due to additional safety and regulatory requirements therefrom.
1.3 This Guide addresses the need for polymeric materials that are safe for their ultimate intended application and consistent in their manufacture and supply.
1.4 This Guide is limited to virgin grade polymeric materials, which may include polymeric materials that have been compounded with additives, and does not include guidance for the use of recycled material(s) in part or whole. Any modification to materials performed by anyone other than the supplier, including use of recycled content, and associated risks therefrom is the responsibility of the user.
1.5 Biocompatibility is addressed as one risk-stratified aspect of safety, including references to existing standards, for example the ISO 10993 standard series or USP.
1.6 The following aspects are addressed to support the purchaser / supplier relationship:
1.6.1 Material characteristics (e.g. shelf life and stability),
1.6.2 Biocompatibility test status,
1.6.3 Regulatory and other compliance status (e.g. FDA Master File, RoHS compliance),
1.6.4 Supply, quality, and regulatory recommendations.
1.7 Medical devices prepared using polymers in compliance with this guide may not necessarily result in a medical device suitable for its intended purpose. Additional testing specific to the finished device, including, as applicable, manufacturing processes, cleaning, sterilization, packaging, environmental and shelf-life exposure, among other tests specific to the intended use are required.
Keywords
Polymer; Medical Grade; Medical Device
Rationale
There is no standard definition, or even industry norms, for the application of ‘medical grade’ or related terminology. This proposed guide will support purchasers (e.g. medical device component manufacturers, OEMs, etc.) and suppliers by creating a guide to support uniform application of terminology and expectations between these groups. Suppliers will be able to establish a clear value proposition and purchasers will be able to communicate requirements and compare available suppliers more effectively. This guide may include recommendations to help establish the supplier / purchaser relationship. Application of this standard guide is intended to improve the safety, quality, and consistency of medical devices, with the patient being the ultimate benefactor.
