ASTM E1173-23 PDF

Overview

ASTM E1173-23: Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations provides a uniform method for assessing the effectiveness of topical antimicrobial skin preparations. These preparations are intended to rapidly and significantly reduce the number of microorganisms on intact skin-immediately, and, in the case of preoperative and vascular precatheterization products, over extended durations. The standard outlines a practice for measuring the reduction of skin microflora using microbiological techniques, ensuring consistency in the evaluation of antimicrobial efficacy for products used prior to surgical procedures, catheterizations, or injections.

Key Topics

• Purpose and Scope

  • Measures reduction of skin microflora following application of antimicrobial skin preparations
  • Applies to preparations used before surgery, vascular catheterization, or injection
  • Requires familiarity with microbiological techniques and regulatory guidelines for human subject protection

• Test Methodology

  • Utilizes human volunteers with high baseline skin flora
  • Involves standardized sample collection before and after product application
  • Employs neutralizing fluids, sample randomization, and control formulations to ensure test validity
  • Uses the "cup scrub technique" for microbiological sampling

• Sampling and Evaluation

  • Designates specific moist and dry anatomical test sites (e.g., inguinal region, abdomen, clavicular and cubital regions)
  • Defines sampling schedules according to intended clinical use (e.g., preoperative, precatheterization, preinjection)
  • Recommends statistical analysis methods, including parametric t-tests or nonparametric models

• Safety and Compliance

  • Adheres to international standardization principles and considers applicable safety, health, and environmental practices
  • Notes that the U.S. FDA may not accept data from this method for certain product approvals

Applications

ASTM E1173-23 is valuable for:

• Medical device and pharmaceutical manufacturers: Standardizes testing for antimicrobial efficacy of skin prep solutions, ensuring reliable product evaluation before regulatory submission or market release.
• Hospitals and clinical laboratories: Provides a protocol for periodic verification of skin preparation product performance in surgical and procedural settings.
• Research laboratories: Supports scientific studies on skin antiseptics, offering a reproducible method for microbiological analysis and statistical evaluation.
• Quality control: Assists in validating batches of antimicrobial skin preparations for compliance with industry best practices.
• Regulatory and compliance professionals: Ensures that testing methodologies align with recognized international standards, facilitating global acceptance and harmonization.

Related Standards

Several related ASTM standards are commonly referenced alongside ASTM E1173-23 for comprehensive antimicrobial and microbiological testing:

• ASTM E1054 – Practices for Evaluation of Inactivators of Antimicrobial Agents
• ASTM E1874 – Practice for Recovery of Microorganisms From Skin using the Cup Scrub Technique
• ASTM E2756 – Terminology Relating to Antimicrobial and Antiviral Agents

ASTM E1173-23 is developed under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents, aligning with international standardization principles set by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Employing ASTM E1173-23 improves the credibility and comparability of skin preparation product evaluations, supporting broader adoption and regulatory confidence in antimicrobial efficacy testing protocols.