ASTM-E1173:2023 Edition

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E1173-23 Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

Published By	Publication Date	Number of Pages
ASTM	2023

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Categories: 11.080.01 - Sterilization and disinfection in general, ASTM

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Description

ASTM E1173-23

Active Standard: Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

ASTM E1173

Scope

1.1 The practice is designed to measure the reduction of the microflora of the skin.

1.2 A knowledge of microbiological techniques is required for these procedures.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3.1 Exception—In this practice, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses.

1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).2

Note 1: Importantly, it must be noted that the FDA currently does not accept data resulting from procedures in this Method for testing products for approval as Vascular Precatheterization Skin Preparations.

1.5 This standard does not purport to address all of the safety problems, 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.

1.6 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.

Keywords

antimicrobial; cup scrub; efficacy; precatheterization; preinjection; preoperative; skin preparation;

ICS Code

ICS Number Code 11.080.01 (Sterilization and disinfection in general)

DOI: 10.1520/E1173-23

Additional information

Standard Title	E1173-23 Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
Published Code	ASTM
Publication Date	2023
ICS Codes	11.080.01 - Sterilization and disinfection in general