ASTM E3357 : 26 New ASTM DRM Policy

1.1 Some countries/regions have adopted the classification “combination product” as a regulatory construct for combined use medical products, while others apply different terminology and constructs. Given the challenges with terminology and concepts, in this standard, terminology, major challenges, and key considerations associated with combined use medical products are identified, including those referred to as “combination products.”

1.2 In this terminology standard, the terms “combined use” and “combination product” as well as categories of combination products and other related terms are defined.

1.3 The terminology provided within this standard reflects common themes and definitions across jurisdictions. Examples and categorization of combination products will be provided. The aim of this terminology standard is to serve as a global reference for combination products and related topics.

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.