What is ISO 16603?
ISO 16603:2004 specifies a laboratory test method to evaluate the resistance of protective clothing materials to penetration by synthetic blood under various levels of pressure. It serves as a preliminary screening procedure to determine whether garments such as surgical gowns, gloves, aprons and other personal protective equipment (PPE) can effectively prevent blood and body fluid exposure, thereby safeguarding healthcare workers and laboratory personnel from infectious hazards.
This standard plays a key role in infection control strategies, especially in environments with a risk of HIV, hepatitis, or other bloodborne pathogen transmission.
If you are looking for ISO 16603 certification, contact us at support@pacificcert.com
Purpose of ISO 16603
The purpose of ISO 16603 is to:
- Provide a standardized test method to assess the barrier performance of protective clothing against synthetic blood.
- Ensure consistency in PPE performance classification, particularly for use in surgical, clinical, and biohazard environments.
- Help manufacturers and testing laboratories determine the pressure levels at which penetration occurs, establishing baseline safety for garments.
This test is often a prerequisite for ISO 16604:2004, which tests for viral penetration using a bacteriophage challenge.
Scope and Applicability
ISO 16603 applies to materials used in the manufacture of single-use or reusable protective clothing, primarily for healthcare, laboratory, and emergency response applications. The test is limited to penetration resistance under synthetic blood challenge and does not cover the mechanical durability or overall garment design.
Applicability:
- Manufacturers of surgical gowns, coveralls, face shields, and gloves
- Hospitals, labs, and infectious disease units procuring PPE
- Testing laboratories assessing protective barrier properties
- Regulatory agencies and product certification bodies
- PPE importers/exporters seeking international compliance
If your PPE products require certification for body fluid resistance, contact us at support@pacificcert.com
Key Definitions
- Synthetic Blood: A test fluid formulated to simulate the physical properties (viscosity and surface tension) of human blood.
- Hydrostatic Pressure: The pressure at which synthetic blood is applied to the protective material in a controlled environment.
- Penetration: The process by which synthetic blood passes through the clothing material, observed visually on the inner side.
- Test Pressure Levels: Defined pressure values ranging from 0 kPa to 20 kPa used to assess resistance performance.
Clause-wise Structure of ISO 16603
Clause | Title | Description |
1 | Scope | Defines the range of application for the test method. |
2 | Normative References | Lists standards required for proper implementation. |
3 | Terms and Definitions | Provides terminology for synthetic blood, penetration, and protective clothing. |
4 | Principle | Explains the concept of using synthetic blood under pressure to test material resistance. |
5 | Apparatus | Describes the synthetic blood solution, test cell, and pressure system. |
6 | Reagents and Materials | Specifies synthetic blood composition and conditioning requirements. |
7 | Test Specimens | Sample preparation instructions for accurate testing. |
8 | Procedure | Step-by-step instructions to conduct the test under varying pressures. |
9 | Interpretation of Results | Criteria for determining penetration and material classification. |
10 | Test Report | Requirements for documenting pressure levels, results, and pass/fail outcomes. |
Performance Classification:
Class | Pressure Level | Resistance Level |
Class 1 | 0 kPa | Minimal resistance |
Class 2 | 1.75 kPa | Low resistance |
Class 3 | 3.5 kPa | Moderate resistance |
Class 4 | 7.0 kPa | High resistance |
Class 5 | 14.0 kPa | Very high resistance |
Class 6 | 20.0 kPa | Maximum tested resistance |
What are the requirements of ISO 16603?
ISO 16603 describes a test method. However, the test evaluates materials at six increasing levels of synthetic blood pressure resistance, ranging from 0 to 20 kPa.
Below are the key requirements:
- Prepare multiple samples of the protective clothing material, ensuring uniform thickness and integrity.
- Condition samples and synthetic blood to controlled temperature and humidity.
- Expose test material to predefined pressure levels using a penetration test cell.
- Examine the opposite surface of the material after exposure for signs of fluid breakthrough.
- Determine the highest-pressure level at which no penetration is observed, which defines the performance classification.
If you need audit assistance for ISO 16603, contact us at support@pacificcert.com
Documentation Required
- Technical data sheets of fabric/material
- Test sample identification and lot/batch numbers
- Test pressure range and results summary
- Visual inspection reports
- Synthetic blood formulation documentation
- Temperature/humidity control logs during test
- ISO 16603 test report including pass/fail status
- Declaration of Conformity (if applicable)
What are the benefits of ISO 16603?
This standard serves as a preliminary screening tool to determine whether a protective material has sufficient barrier performance before undergoing more complex viral penetration tests such as ISO 16604. Below are the benefits:
- Confirms the material provides a barrier against potential bloodborne pathogen exposure.
- Accepted by health regulators and procurement bodies worldwide.
- Assures buyers and users of compliance with medical safety standards.
- Required in many markets for Class II/III medical protective apparel.
- Critical for pandemic and infectious disease control stockpiles.
- Serves as a screening method before viral penetration testing.
- Demonstrates proactive product quality assurance.
If your PPE products need ISO 16603 certification, contact us at support@pacificcert.com
Certification Timeline – ISO 16603
The total time to achieve ISO 16603 testing and certification typically ranges between 2 to 4 weeks, depending on laboratory capacity, material complexity and documentation readiness.
Week-wise Breakdown
Week | Stage | Activity |
Week 1 | Application & Sample Submission | Submission of product samples and technical documentation for review. |
Week 2 | Testing at Accredited Laboratory | Execution of synthetic blood penetration testing at multiple pressure levels. |
Week 3 | Report Compilation & Review | Laboratory prepares detailed report and result analysis. Certification body reviews the outcome. |
Week 4 | Certification Issuance | Certificate of compliance issued upon successful test results and review. |
For detailed guidance or to begin the ISO 16603 process, contact us at support@pacificcert.com
How Pacific Certifications Can Help?
Pacific Certifications, accredited by ABIS, offers independent audit and certification services for PPE standards, including ISO 16603:2004.
We assist with:
- Coordinating testing at ISO/IEC 17025-accredited laboratories
- Reviewing test results and documentation for compliance
- Issuing a Certificate of Conformity following successful testing
- Ensuring your product meets regulatory and market requirements
- Providing certification support for ISO 16603 as well as follow-up standards like ISO 16604 (viral penetration)
If you are looking for ISO 16603 certification, contact us at support@pacificcert.com
FAQs – ISO 16603
Is ISO 16603 a mandatory certification?
It is not mandatory globally, but highly recommended or required by many regulators for PPE used in medical and infectious environments.
What does ISO 16603 testing prove?
It demonstrates that the material can resist synthetic blood penetration at specified pressure levels, simulating real-world exposure to bloodborne risks.
Is ISO 16603 testing enough for viral protection claims?
No. It is a preliminary screening test. For viral protection, ISO 16604:2004 testing is required using a bacteriophage challenge.
How long does certification last?
Certification is typically valid for 3 years, but retesting is advised for design changes, new batches, or regulatory updates.
Can ISO 16603 be used for gloves and face shields?
It is primarily used for clothing and drape materials, but certain glove or accessory materials may be evaluated using similar protocols.
Ready to get ISO 16603 certified?
Contact Pacific Certifications to begin your certification journey today!
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