Work Item
ASTM WK89662
New Guide for the Criteria and Classification of Medical Grade Polymers for Non-Implantable Applications
1. Scope
1.1 This proposed Standard Guide provides information for purchasers (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 The proposed standard will address polymeric materials for a wide range of applications within the medical device and technology ecosystem but excludes implantable applications due to additional safety and regulatory requirements therefrom. This includes stratifying materials by classification for risk associated with the final application.
1.3 The proposed standard is driven by the need for polymeric materials that are safe for their ultimate intended application and consistent in their manufacture and supply.
1.4 References to external measures are included for biocompatibility as one measure of safety includes risk-stratified applications of existing standards, for example the ISO 10993 standard series and USP <88> classifications.
1.5 The following aspects are recommended to support the purchaser / supplier relationship:
1.5.1 Material characteristics (e.g. shelf life and stability),
1.5.2 Biocompatibility test status,
1.5.3 Regulatory and other compliance status (e.g. FDA Master File, RoHS compliance),
1.5.4 Supply, quality, regulatory recommendations.
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.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 02-15-2024
Technical Contact: Scott Taylor
Item: 000
Ballot:
Status: