ISO 16604-2004 PDF

Full title and description

ISO 16604:2004 — Clothing for protection against contact with blood and body fluids — Determination of resistance of protective clothing materials to penetration by blood‑borne pathogens — Test method using Phi‑X174 bacteriophage. The standard specifies a laboratory test using a bacteriophage surrogate to assess whether materials used in protective clothing allow viral penetration under continuous liquid contact and defined hydrostatic pressure conditions.

Abstract

ISO 16604:2004 defines a sensitive virological challenge test (Phi‑X174 bacteriophage) performed in a continuous liquid contact arrangement (using the ISO 13994 test cell/apparatus) to determine pass/fail resistance of protective clothing materials to penetration by blood‑borne pathogens. The procedure includes hydrostatic pressure stages and an assay to detect viral penetration; it can be time‑consuming and may be unsuitable for materials with thick, absorbent inner liners or for routine production quality control.

General information

• Status: Published (International Standard; confirmed following review).
• Publication date: April 2004 (2004-04).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 13.340.10 (Protective clothing).
• Edition / version: Edition 1 (2004).
• Number of pages: 16 (as published by ISO).

Scope

Specifies a laboratory test method to determine the resistance of materials used in protective clothing to penetration by blood‑borne pathogens, employing Phi‑X174 bacteriophage as a surrogate microorganism under continuous liquid contact. The method uses the ISO 13994 test apparatus and defines pass/fail criteria based on detection of viral penetration at specified hydrostatic pressures; it is intended for material assessment and comparative testing rather than routine fast throughput quality control in many cases.

Key topics and requirements

• Use of Phi‑X174 bacteriophage as a viral surrogate to simulate blood‑borne pathogen challenge.
• Continuous liquid contact test configuration with defined hydrostatic pressure stages and timed exposures.
• Use of the ISO 13994 test cell/apparatus to apply pressure and contain the challenge fluid.
• Sensitive assay procedures to detect and quantify viral penetration (pass/fail based on detection limits).
• Limitations noted for materials with thick, absorbent inner liners that can absorb challenge fluid and confound results.
• Not generally recommended as a rapid production QC test because of assay complexity and test duration.

Typical use and users

Used by PPE and protective‑clothing manufacturers, independent testing laboratories, certification bodies, healthcare product regulators, and procurement/specification teams to assess barrier performance of gowns, coveralls, drapes and other medical/industrial protective garments against viral (blood‑borne) penetration. Results inform design, claims about viral protection, and comparative performance evaluations.

Related standards

Closely associated with ISO 16603 (synthetic blood penetration screening test) and with comparable national/industry tests such as ASTM F1671 (Phi‑X174 bacteriophage test method). The ISO 13994 apparatus specification is referenced for the test cell. Related product classification standards (e.g., ANSI/AAMI PB70 for medical protective apparel barrier classification) and newer/replacement test protocols or regional adaptations should be checked when specifying compliance.

Keywords

protective clothing; blood‑borne pathogens; viral penetration; Phi‑X174 bacteriophage; hydrostatic pressure; ISO 13994; ISO 16603; ASTM F1671; barrier performance; PPE testing.

FAQ

Q: What is this standard?

A: ISO 16604:2004 is an ISO test method that specifies a laboratory procedure for assessing resistance of protective clothing materials to penetration by blood‑borne pathogens using Phi‑X174 bacteriophage as a surrogate.

Q: What does it cover?

A: It covers the test arrangement (continuous liquid contact), the challenge organism (Phi‑X174 bacteriophage), application of hydrostatic pressure using the ISO 13994 apparatus, and the assay/detection criteria used to determine whether viral penetration has occurred. It also notes limitations (for example, thick absorbent liners and the time/intensity of the assay).

Q: Who typically uses it?

A: PPE manufacturers, independent test laboratories, conformity assessment and certification bodies, regulatory agencies, and healthcare procurement/specification teams use this standard to evaluate or compare the viral barrier performance of materials and assemblies.

Q: Is it current or superseded?

A: According to ISO's publication page, ISO 16604:2004 was reviewed and confirmed in 2025 and the publication remains current as published by ISO. Users concerned about the absolute latest status (including any revisions or replacements) should verify the current status with ISO or their national standards body.

Q: Is it part of a series?

A: Yes. ISO 16604 is commonly paired with ISO 16603 (synthetic blood penetration test) and is functionally analogous to ASTM F1671; these documents together form the suite of test methods used to evaluate liquid and viral penetration resistance of protective clothing.

Q: What are the key keywords?

A: Phi‑X174, bacteriophage, viral penetration, blood‑borne pathogens, protective clothing, hydrostatic pressure, ISO 13994, barrier test, PPE, liquid challenge.