ISO 16604:2004 PDF

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-X 174 bacteriophage

Open preview (PDF)

Title (English):

ISO 16604:2004

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 16
Publication date:: March 30, 2004
Edition:: ISO IS 16604 edition 1 version 1
ICS:: 13.340.10

Delivery type:

Full version25 €Read online 24h10 €Read online 72h15 €

Document language:

enru

Delivery time:Immediate download

Price:25 €

Description (English):

ISO 16604:2004 describes a laboratory test method for measuring the resistance of materials used in protective clothing to penetration by blood-borne pathogens. This test method uses a surrogate microbe under conditions of continuous liquid contact. Protective clothing "pass/fail" determinations are based on the detection of viral penetration at a specific hydrostatic pressure using the ISO 13994 test apparatus. This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorbs the challenge fluid. This test method involves a sensitive assay procedure. Because of the length of time required to complete this test method, it might not be suitable for use as a material or protective clothing quality control or assurance procedure.

Technical details

Technical committee: ISO/TC 94/SC 13 - Protective clothing
SKU: ISO 16604:2004

Abstract

Overview

ISO 16604:2004 specifies a laboratory test method for measuring the resistance of materials used in protective clothing to penetration by blood‑borne pathogens. The method uses the non‑pathogenic Phi‑X174 bacteriophage as a surrogate virus and evaluates viral penetration under conditions of continuous liquid contact and controlled hydrostatic pressure using the ISO 13994 test apparatus. ISO 16604 was prepared by ISO/TC 94 and is based on ASTM F1671-97b.

Key topics and technical requirements

Surrogate microbe: Phi‑X174 bacteriophage is used to model viruses (similar in size/shape to HCV) for HBV/HCV/HIV inferences.
Challenge suspension: Bacteriophage in nutrient broth with surface tension adjusted to (0.042 ± 0.002) N/m to approximate the lower range of blood/body fluids.
Hydrostatic pressure testing: Procedures A and B use a pressurization of 14.0 kPa; Procedures C and D use a stepped approach up to 20.0 kPa to rank performance.
Pass/fail criterion: Detection of viral penetration (plaque assay) on the material’s normal inside surface following exposure.
Assay and sensitivity: The method uses a sensitive plaque assay procedure; it is time‑consuming and not always suitable for routine quality control.
Limitations:
- Not always effective for materials with thick absorbent inner liners that soak up challenge fluid.
- Does not simulate all real‑world stresses (flexing, abrasion, mechanical pressures >345 kPa, pre‑wetting, laundering, sterilization).
- Applies to materials and specific constructions (e.g., seams), not complete garment design or interfaces.

Applications and users

ISO 16604 is intended for:

PPE and medical protective clothing manufacturers validating barrier performance of materials (gowns, drapes, coveralls).
Independent test laboratories performing viral penetration testing and comparative ranking of materials.
Regulatory bodies and procurement teams assessing barrier claims for medical devices and protective garments.
R&D teams developing new barrier fabrics or surface treatments.
Infection control specialists and safety engineers performing risk assessments to select appropriate protective clothing.

Practical use advises performing risk assessments and, where relevant, preconditioning tests (sterilization, laundering, abrasion, pre‑wetting) to evaluate performance under expected use and storage conditions.

Related standards

ISO 13994 - apparatus for liquid penetration under pressure
ISO 16603 - similar method using synthetic blood
ASTM F1671 - precursor standard (basis for ISO 16604)

Keywords: ISO 16604, Phi‑X174, viral penetration test, blood‑borne pathogens, protective clothing testing, hydrostatic pressure, PPE barrier performance.

Related standards

Mentioned in the description and other ISO standards

Abstract

Overview

Key topics and technical requirements

Surrogate microbe: Phi‑X174 bacteriophage is used to model viruses (similar in size/shape to HCV) for HBV/HCV/HIV inferences.
Challenge suspension: Bacteriophage in nutrient broth with surface tension adjusted to (0.042 ± 0.002) N/m to approximate the lower range of blood/body fluids.
Hydrostatic pressure testing: Procedures A and B use a pressurization of 14.0 kPa; Procedures C and D use a stepped approach up to 20.0 kPa to rank performance.
Pass/fail criterion: Detection of viral penetration (plaque assay) on the material’s normal inside surface following exposure.
Assay and sensitivity: The method uses a sensitive plaque assay procedure; it is time‑consuming and not always suitable for routine quality control.
Limitations:
- Not always effective for materials with thick absorbent inner liners that soak up challenge fluid.
- Does not simulate all real‑world stresses (flexing, abrasion, mechanical pressures >345 kPa, pre‑wetting, laundering, sterilization).
- Applies to materials and specific constructions (e.g., seams), not complete garment design or interfaces.

Applications and users

ISO 16604 is intended for:

PPE and medical protective clothing manufacturers validating barrier performance of materials (gowns, drapes, coveralls).
Independent test laboratories performing viral penetration testing and comparative ranking of materials.
Regulatory bodies and procurement teams assessing barrier claims for medical devices and protective garments.
R&D teams developing new barrier fabrics or surface treatments.
Infection control specialists and safety engineers performing risk assessments to select appropriate protective clothing.

Related standards

ISO 13994 - apparatus for liquid penetration under pressure
ISO 16603 - similar method using synthetic blood
ASTM F1671 - precursor standard (basis for ISO 16604)

Keywords: ISO 16604, Phi‑X174, viral penetration test, blood‑borne pathogens, protective clothing testing, hydrostatic pressure, PPE barrier performance.

ISO 16604:2004 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Clothing for protection against liquid chemicals — Determination of the resistance of protective clothing mat…

Clothing for protection against contact with blood and body fluids. Determination of the resistance of protec…

Systems and software engineering — Software life cycle processes

Asset management — Vocabulary, overview and principles

Asset management — Asset management system — Requirements

Information technology — Radio frequency identification device conformance test methods — Part 2: Test method…

Information technology — Multimedia framework (MPEG-21) — Part 22: User Description

Milk — Determination of the lactoperoxidase activity — Photometric method (Reference method)