ASTM D7907 - 14(2019) - Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves

ASTM D7907 - 14(2019)

Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves

Status : Current   Published : May 2019



1.1 The methods herein specify two analytical tests for quantitatively evaluating surface bactericidal efficacy of medical examination gloves incorporated with bactericidal properties. They may be used for the determination of bactericidal activity on either the outer or inner glove surface. The methods incorporate bacterial challenges in two different formats: Method (A) a saline or buffered saline solution, and Method (B) a saline or buffered saline solution containing an organic load. Each method represents a different means of microbial contamination that can be expected in the healthcare environment.

1.2 Methods described herein are not appropriate for virucidal, fungicidal, tuberculocidal or sporicidal evaluations as each of these categories require unique culture techniques and testing conditions. Results of the test methods described in this document are limited to bactericidal efficacy against vegetative bacteria.

1.3 A more expansive glove description, such as broad spectrum antimicrobial efficacy, would require testing of a broader list of microbial species than vegetative bacteria alone. It is recommended that interested manufacturers discuss species and strain selections with appropriate regulatory agencies before testing is commenced.

1.4 Testing is to be performed by individuals trained in microbiological techniques under appropriate controlled conditions to ensure integrity of results and personnel safety.

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

1.6  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. Most regulatory agencies require compliance with Biocompatibility guidelines under ISO 10993.

1.7  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.

Standard NumberASTM D7907 - 14(2019)
TitleStandard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
Publication Date01 May 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors antibacterial, antimicrobial, bactericidal, bacteriocidal, biocidal, exam glove, examination glove, gloves, medical, medical glove, organic load, surface active
File Size100 KB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version

Develop a PAS

Develop a fast-track standardization document in 9-12 months

Worldwide Standards
We can source any standard from anywhere in the world