ASTM D7102-17 (2022)e1 PDF

Full title and description

St ASTM D7102-17(2022)e1 — Standard Guide for Determination of Endotoxin on Sterile Medical Gloves. This guide describes a standard sample preparation procedure and presents recognized test methods for detecting and reporting bacterial endotoxin (lipopolysaccharide, LPS) on gloves labeled and supplied as sterile. It is intended to support manufacturers and testing laboratories in assessing endotoxin contamination on finished sterile glove products.

Abstract

ASTM D7102-17(2022)e1 provides guidance for selection and execution of endotoxin test methods for sterile medical gloves. The document specifies a mandatory sample-preparation technique and summarizes three established bacterial endotoxin assays commonly used to evaluate glove extracts. It clarifies applicability (sterile gloves only), limits the scope to bacterial endotoxins (not other pyrogens), and highlights the need for product-specific validation and interference controls when necessary.

General information

• Status: Current / Active (definitive)
• Publication date: June 1, 2022 (designation D7102-17(2022)e1; includes amendments/changes recorded through October 14, 2024)
• Publisher: ASTM International
• ICS / categories: 11.140 — Hospital equipment
• Edition / version: D7102-17(2022)e1 (original designation D7102-17, reaffirmed/issued in the 2022/e1 release)
• Number of pages: 5

Scope

The guide covers procedures for sample preparation and describes selected methodologies for determining bacterial endotoxin on gloves when such testing is appropriate. It applies to gloves that are marketed and labeled as sterile; it does not apply to non-sterile/packaged examination gloves for which endotoxin reporting is generally not appropriate after handling or opening. The standard does not cover pyrogens other than bacterial endotoxins and does not provide detailed laboratory validation protocols or analyst qualification requirements—those are handled by product-specific validation and internal laboratory procedures.

Key topics and requirements

• Mandatory sample preparation protocol for glove extraction prior to testing.
• Overview of three established bacterial endotoxin test methods (typical approaches include gel-clot, turbidimetric, and chromogenic LAL-based assays) and recommendation to use a secondary method when sample interference is suspected.
• Requirement for interference controls and appropriate positive/negative controls to confirm assay suitability for the glove extract.
• Emphasis on testing finished sterile product that has undergone all manufacturing and processing steps that could influence endotoxin levels.
• Clarification that the guide does not address non-bacterial pyrogens or safe/clinical use of gloves; users are responsible for compliance with applicable regulatory and safety requirements.
• Recommendation for product-specific method validation and documentation of assay performance for each glove type/product under test.

Typical use and users

This guide is primarily used by medical glove manufacturers, quality control and quality assurance laboratories, contract testing laboratories, and regulatory affairs professionals involved in medical device and sterile barrier assurance. It is useful during final product release testing, incoming/periodic quality checks, process change assessments, and internal investigations into endotoxin contamination.

Related standards

Relevant complementary standards and guidance frequently used alongside ASTM D7102 include general bacterial endotoxin test compendial standards (for example, pharmacopeial Bacterial Endotoxins Test procedures), the ISO 10993 series on biological evaluation of medical devices (notably sections addressing pyrogenicity/biocompatibility), and earlier or related ASTM documents addressing medical gloves and test methods. Laboratories should align test selection and validation with applicable regulatory and pharmacopeial requirements in their markets.

Keywords

endotoxin; lipopolysaccharide; LPS; LAL; gel-clot; chromogenic; turbidimetric; sterile gloves; non-pyrogenic; pyrogenic; glove extraction; sample preparation; medical gloves; quality control

FAQ

Q: What is this standard?

A: ASTM D7102-17(2022)e1 is a guide that establishes a standard sample-preparation method and describes recognized bacterial endotoxin assays for determining endotoxin on sterile medical gloves.

Q: What does it cover?

A: It covers when and how to prepare glove samples and describes selected endotoxin test methods (commonly LAL-based approaches). It is limited to bacterial endotoxins on products labeled as sterile and does not address other pyrogens or glove use instructions.

Q: Who typically uses it?

A: Glove manufacturers, QC/QA laboratories, contract testing labs, and regulatory professionals use this guide for product release testing, validation checks, and investigating endotoxin issues on sterile gloves.

Q: Is it current or superseded?

A: The designation D7102-17(2022)e1 is the current definitive guide published in 2022 (reaffirmation/release of the D7102-17 designation). The published document is short (5 pages) and has record entries for amendments/updates through October 14, 2024.

Q: Is it part of a series?

A: It belongs to ASTM’s D11 committee work on medical devices and related materials and aligns with other standards addressing biological evaluation and test methods; it is a focused guide rather than a broad multi-part series.

Q: What are the key keywords?

A: Endotoxin, LPS, LAL, sterile gloves, gel-clot, chromogenic assay, turbidimetric assay, sample preparation, non-pyrogenic, medical glove testing.