ISO 16603:2004

INTERNATIONAL ISO
STANDARD 16603
First edition
2004-04-01


Clothing for protection against contact
with blood and body fluids —
Determination of the resistance of
protective clothing materials to
penetration by blood and body fluids —
Test method using synthetic blood
Vêtements de protection contre les contacts avec le sang et les fluides
corporels — Détermination de la résistance des matériaux des
vêtements de protection à la pénétration par le sang et les fluides
corporels — Méthode d'essai utilisant un sang synthétique





Reference number
ISO 16603:2004(E)
©
ISO 2004

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ISO 16603:2004(E)
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ii © ISO 2004 – All rights reserved

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ISO 16603:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Principle . 2
5 Synthetic blood . 2
6 Apparatus . 3
7 Test specimens . 3
7.1 Selection . 3
7.2 Preparation . 4
8 Procedure . 4
8.1 Preliminary measures. 4
8.2 Test apparatus setup. 4
8.3 Test procedure . 5
8.4 Final cleanup of test apparatus . 6
9 Test report . 6
Annex A (informative) Synthetic blood formula . 9
Annex B (informative) Sources of apparatus. 10
Bibliography . 11

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ISO 16603:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 16603 was prepared by Technical Committee ISO/TC 94, Personal safety — Protective clothing and
equipment, Subcommittee SC 13, Protective clothing. It is based on ASTM F1670-98.
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ISO 16603:2004(E)
Introduction
Workers, primarily those in the health care profession, involved in treating and caring for individuals injured or
sick, can be exposed to biological liquids capable of transmitting disease. These diseases, which may be
caused by a variety of microorganisms, can pose significant risks to life and health. This is especially true of
blood-borne viruses which cause hepatitis [hepatitis B virus (HBV) and hepatitis C virus (HCV)] and acquired
immune deficiency syndrome (AIDS) [human immunodeficiency viruses (HIV)]. Since engineering controls
cannot eliminate all possible exposures, attention is placed on reducing the potential of direct skin contact
through the use of protective clothing.
This International Standard is concerned with protective clothing and related protective devices designed to
protect against the penetration of blood or body fluids. This test method addresses only the performance of
materials or certain material constructions (e.g. seams) used in protective clothing. This test method does not
address the design, overall construction and components, or interfaces of garments or other factors which can
affect the overall protection offered by the protective clothing.
It is emphasized that the test does not necessarily simulate conditions to which clothing materials are likely to
be exposed in practice. The use of test data should therefore be restricted to broad comparative assessment
of such material according to their synthetic blood penetration resistance characteristics. Testing prior to
degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the
protective barrier, could lead to a false sense of security. Tests which assess the impact of storage conditions
and shelf life on the penetration resistance for disposable products, and the effects of laundering and
sterilization on the penetration resistance for reusable products, should be considered. The integrity of the
protective barrier can also be compromised during use by such effects as flexing and abrasion or pre-wetting
by contaminating materials such as alcohol and perspiration. If these conditions are of concern, the
performance of protective clothing materials for synthetic blood penetration should be evaluated following an
appropriate preconditioning technique representative of the expected conditions of use.
Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially
infectious materials. Many factors can effect the wetting and penetration characteristics of body fluids, such as
surface tension, viscosity and polarity of the fluid, as well as the structure and relative hydrophilicity or,
hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is
[2]
approximately 0,042 N/m to 0,060 N/m. In order to help simulate the wetting characteristics of blood and
body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface
tension range, i.e. (0,042 ± 0,002) N/m.
Part of this method for exposing the protective clothing material specimens with synthetic blood involves
pressurization of the test cell to 14,0 kPa (in Procedures A and B). This hydrostatic pressure has been
[3]
documented to produce test results that correlate with a human factors validation. Some studies, however,
[4] [5]
suggest that mechanical pressures exceeding 345 kPa can occur during actual use. Therefore, it is
important to understand that this test method does not simulate all the physical stresses and pressures that
are exerted on protective clothing in use. This test method can also be used as a screening test to determine
which time and pressure protocol is appropriate for evaluating the viral-resistance-properties of protective
apparel with a more sophisticated barrier test method as described in ISO 16604. Procedures C and D use a
stepped pressurization approach with pressures up to 20,0 kPa. These procedures simulate a range of
possible procedures for ranking material performance.
Given the variety of health care settings, activities, and the potential for exposure to blood or body fluids, the
barrier requirements for protective clothing materials will change with the application. The choice of an
appropriate test method depends on the specific application of protective clothing and its intended use. A risk
[1]
assessment should be performed to determine the level of risk for determining the appropriate test method.

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INTERNATIONAL STANDARD ISO 16603:2004(E)

Clothing for protection against contact with blood and body
fluids — Determination of the resistance of protective clothing
materials to penetration by blood and body fluids — Test
method using synthetic blood
1 Scope
This International Standard describes a laboratory test method for measuring the penetration resistance of
clothing materials to blood and body fluids. This test method uses a synthetic blood in continuous contact with
the material specimen at specified set of conditions using the ISO 13994 test apparatus.
This test method is not always effective in testing protective clothing materials having thick, inner liners which
readily absorb the synthetic blood.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 3801, Textiles — Woven fabrics — Determination of mass per unit length and mass per unit area
ISO 5084, Textiles — Determination of thickness of textiles and textile products
ISO 13994, Clothing for protection against liquid chemicals — Determination of the resistance of protective
clothing materials to penetration by liquids under pressure
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
blood-borne pathogen
infectious secreted or excreted bacterium, virus, or other disease-inducing microbe carried in blood or other
body fluids
3.2
blood-resistant material
material that restricts blood and body fluid penetration
3.3
body fluid
any liquid produced (secreted or excreted) by the body
NOTE For the purpose of this International Standard, body fluids include those liquids potentially infected with blood-
borne pathogens, including, but not limited to, blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid and
peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid that is visibly contaminated with blood, and
all body fluids in situations where it is difficult or impossible to differentiate between body fluids.
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ISO 16603:2004(E)
3.4
body fluid simulant
liquid which is used to act as a model for human body liquids
NOTE In this International Standard, synthetic blood is used as a body fluid simulant.
3.5
penetration
flow of a liquid through closures, porous materials, seams and holes or other imperfections in a protective
clothing material on a non-molecular level
NOTE In this International Standard, the penetration liquid is synthetic blood.
3.6
protective clothing
item of clothing that is specifically designed and constructed for the intended purpose of isolating all or part of
the body from a potential hazard; or, isolating the external environment from contamination by the wearer of
the clothing
3.7
synthetic blood
mixture of an amaranth dye, surfactant, thickening agent, inorganic salts, and distilled water having a surface
tension and viscosity representative of blood and some other body fluids
NOTE The synthetic blood in this International Standard does not simulate all of the characteristics of real blood or
body fluids, for example, colour, coagulation and content of cell matter.
4 Principle
The resistance of a protective clothing material to penetration by blood and body fluids is determined by
subjecting the material to synthetic blood as a body fluid simulant for a specified time and pressure sequence
and observing if visible penetration of the liquid occurs.
In the penetration test apparatus, the clothing material acts as a partition separating the body fluid simulant
from the viewing side of the test cell.
Any evidence of synthetic blood penetration constitutes failure. Results are reported as “pass/fail”.
5 Synthetic blood
The synthetic blood shall meet the following requirements:
 surface tension: (0,042 ± 0,002) N/m
 pH: (7,3 ± 0,1)
 viscosity: (2,7 ± 0,3) mPa⋅s
 conductivity: (12,0 ± 1,2) mS/cm
NOTE A suitable method of preparation can be found in Annex A.
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ISO 16603:2004(E)
6 Apparatus
6.1 Penetration test cell, as specified in ISO 13994, to restrain the specimen during contact with the
pressurized test synthetic blood.
In the test cell, the specimen acts as a partition separating synthetic blood from the view side of the test cell. It
consists of a cell body that is fastened to a cell support. The cell bo
...