New Specification for Medical-Grade Porous Polyethylene membranes
1. Scope
1. Scope
1.1 This specification covers porous polyethylene (PE) membranes intended for use in medical devices or components of medical devices, such as (stent) grafts, occlusion & embolization devices and intravenous infusion products. PE membranes are typically produced by extruding a PE solution through a slit die, followed by cooling and crystallization of the extruded PE tape. A porous membrane is produced by simultaneous or sequential drawing of the tape in 2 directions and removing the solvent during or after the drawing steps. PE membrane is typically provided in slit rolls, sheets or precut forms.
1.2 This standard is intended to describe the requirements and the procedures to be followed for testing PE membranes as a component for medical devices prior to the manufacturing processes of the medical device, which typically involves steps such as lamination, assembling, and sterilization. This specification does not purport to address the requirements for the finished medical devices or the testing that is needed for medical devices that are fabricated from the components specified herein.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Due to increased use of polyethylene membranes to replace PFAS or ePTFE based membranes, a new material specification standard is proposed for medical grade porous polyethylene membranes. These membranes are used in (cardio)vascular devices such as embolization and occlusion devices and stent grafts but also in intravenous infusion products.
