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Significance and Use
All approved F04 standards have their terms reproduced in this terminology document, per section 1.3. The terms are listed both alphabetically, and by subcommittee of origin, per section 1.2.
This standard maintains a single source for terminology reference for ASTM Committee F04.
This standard assists in the authoring of new ASTM standards, and standard revisions, where authors can find and utilize existing terms to avoid generation of extraneous, duplicative, or contradicting terms.
Some terms may appear more than once.
In some cases, multiple definitions of a term are needed, based on the variety of applications and sectors to which it applies.
Because this terminology standard is a repository for all approved terms of Committee F04, it may become evident that multiple definitions for a term have been developed, but need coordination.
An objective of this document is to make duplication evident, and to facilitate harmonization of terms by Committee F04 as appropriate.
Appendix X2 provides background on the history and objectives of this terminology standard.
1.1 This terminology standard is a repository for the terms, and their standardized definitions, as relates to the technical standards generated by ASTM Committee F04 on Medical and Surgical Materials and Devices. The meanings and explanations of the technical terms have been written for both the non-expert and the expert user.
1.2 The terms are listed in alphabetical sequence; in Appendix X1 they are listed by the subcommittee of origin.
1.3 At a minimum, this standard is updated annually (at a time corresponding to the publication of the Annual Book of ASTM Standards containing this terminology standard) to editorially include any terms approved in the Committee's technical standards.
1.4 The originating standard of each term is included for informational purposes, following each listing of a term and its associated definition.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Historical ASTM Standards
ICS Number Code 01.040.11 (Health care technology (Vocabularies)); 11.040.01 (Medical equipment in general)
UNSPSC Code 42000000(Medical Equipment and Accessories and Supplies)
ASTM F2809-10, Standard Terminology Relating to Medical and Surgical Materials and Devices, ASTM International, West Conshohocken, PA, 2010, www.astm.orgBack to Top