ISO 22610-2018 PDF

Full title and description

ISO 22610:2018 — Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration. This International Standard specifies a laboratory test method, associated apparatus and procedure used to assess how well materials and assemblies resist the passage of bacteria carried in a liquid when subjected to mechanical rubbing (expressed as a Barrier Index, I_B).

Abstract

ISO 22610:2018 defines a dynamic wet-microbial challenge test in which a bacteria‑inoculated donor material is placed against the test specimen while a rotating agar collector and a rubbing element (finger) simulate liquid contact and mechanical action. Results are reported as colony counts/Barrier Index (I_B); the method is used to compare materials and to support product performance claims for surgical drapes, gowns and clean‑air suits.

General information

• Status: Published (current international standard; under periodic review).
• Publication date: September 2018 (Edition 2, published 2018-09).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.140 (Hospital equipment) and 13.340.10 (Protective clothing / medical protective garments).
• Edition / version: Edition 2 (2018).
• Number of pages: 26 pages (typical ISO published length).

Scope

This document specifies a laboratory test method to determine the resistance of materials (and material assemblies) used in surgical drapes, gowns and clean air suits to penetration by bacteria carried in a liquid under conditions of simultaneous liquid contact and rubbing. It applies to materials used as medical devices for patients, clinical staff and equipment and is intended for comparative assessment, product development and conformity/performance evaluation.

Key topics and requirements

• Test apparatus description: rotating agar collector, donor material, rubbing implement (finger), and mechanical drive to produce repeatable rubbing action.
• Preparation and inoculation of donor liquid with specified test organism(s) and challenge concentration.
• Controlled test conditions: rotation speed, rubbing force, exposure time and environmental parameters to ensure repeatability and comparability.
• Result expression as colony counts and conversion to a Barrier Index (I_B) for material ranking; I_B values indicate relative wet microbial resistance (I_B = 6.0 is commonly referenced as the maximum for “no penetration” in some performance contexts).
• Use of the method to support performance claims in product specifications, design verification and comparative testing alongside other barrier tests (hydrostatic, synthetic‑blood, viral penetration).

Typical use and users

Manufacturers of surgical gowns, drapes and clean‑air suits; test laboratories performing conformity and performance testing for healthcare textiles; regulatory and procurement bodies specifying barrier performance for medical devices; research and development teams working on material selection and barrier enhancement. Users apply ISO 22610 for product development, batch verification and to support compliance with broader surgical textile standards.

Related standards

Commonly referenced alongside EN ISO 22612 (resistance to dry microbial penetration), ISO 16603 / ISO 16604 (synthetic blood and viral penetration under pressure), ISO 22609 (synthetic‑blood splash tests for face masks), EN 13795 (general requirements and performance levels for surgical drapes/gowns) and regional specifications such as ANSI/AAMI PB70 and relevant ASTM test methods. These complementary methods together give a fuller picture of liquid and microbial barrier performance.

Keywords

surgical drapes, surgical gowns, clean air suits, wet bacterial penetration, resistance to microbial penetration, barrier index, I_B, test method, medical textiles, protective clothing, EN ISO 22610, ISO 22610:2018.

FAQ

Q: What is this standard?

A: ISO 22610:2018 is an ISO test method that defines a laboratory procedure to measure how well materials used in surgical drapes, gowns and clean air suits resist penetration by bacteria carried in liquid under simultaneous rubbing action.

Q: What does it cover?

A: It covers apparatus, sample preparation, inoculation, test execution (rotation, rubbing force, time), result counting and reporting (colonies and Barrier Index). It is intended for comparative and performance testing rather than prescribing clinical use conditions.

Q: Who typically uses it?

A: Medical textile manufacturers, independent testing laboratories, product designers, regulatory assessors and procurement specialists who need objective data on wet microbial barrier performance.

Q: Is it current or superseded?

A: ISO 22610:2018 is the current edition published in September 2018 (Edition 2). ISO standards are reviewed periodically; the ISO record shows it as published and subject to the normal ISO review lifecycle. Users should check with their national standards body or ISO for any updates or draft revisions before relying on the standard for procurement or certification.

Q: Is it part of a series?

A: Yes — it is part of a group of test methods and product standards addressing barrier performance of medical/surgical textiles and protective clothing (for example EN ISO 22612 for dry microbial penetration, ISO 16603/16604 for synthetic‑blood/viral penetration and ISO 22609 for synthetic‑blood splash tests). These documents are often used together when specifying or validating surgical gown/drape performance.

Q: What are the key keywords?

A: Wet bacterial penetration, Barrier Index (I_B), surgical gowns, surgical drapes, clean air suits, microbial barrier, test method, ISO 22610:2018.