Work Item
ASTM WK70143

New Guide for Sampling Methods of Tissue Engineered Medical Products (TEMPs) for Sterility Assurance

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

Keywords

TEMPs; sterility; sampling

Rationale

Implantation into a patient requires sterility assurance of TEMPs. However, sampling methods for liquid based products are not sufficient to obtain a representative sample to provide sterility information for TEMPs. The proposed standard would provide general guidelines for sampling methods as a means to help establish quality control and sterility assurance for TEMPs.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: F04.45

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 10-09-2019

Technical Contact: Richard McFarland

Item: 000

Ballot:

Status: