What is this ISO 22612?
ISO 22612:2005 is an international testing standard that specifies a method for evaluating the resistance of protective clothing materials to dry microbial penetration. It is particularly applicable to garments and materials intended to protect against airborne biological contamination, including bacteria carried by dust or dry particles.
This test method is a critical component in the overall performance assessment of medical protective clothing, especially in surgical environments, isolation wards, and biological laboratories, where controlling exposure to infectious agents is vital for health worker and patient safety.
If you are looking for ISO 22612 testing and certification, contact us at support@pacificcert.com
What is the purpose of ISO 22612?
The main purpose of ISO 22612:2005 is to:
- Determine the ability of protective clothing materials to resist penetration by dry, airborne microorganisms carried on particles.
- Support the risk assessment of protective clothing used in healthcare and laboratory settings.
- Complement other standards such as ISO 22610 (wet bacterial penetration) and ISO 16604 (bloodborne pathogen resistance), ensuring comprehensive bioprotective evaluation.
If you are looking for ISO 22612-compliant clothing certification, contact us at support@pacificcert.com
Scope and Applicability
ISO 22612 outlines the test method and it is used as part of broader compliance and classification systems for protective clothing.
This standard is applicable to:
- Manufacturers of surgical gowns, coveralls, masks, and drapes
- Medical device testing laboratories
- Pharmaceutical cleanroom apparel and biological containment suits
- Healthcare and PPE regulators
- Testing and certification bodies validating infection prevention claims
If your product line includes sterile or medical clothing, contact us at support@pacificcert.com
Key Definitions
- Dry Microbial Penetration: The transfer of microorganisms via air currents or mechanical forces acting on dry particles or dust.
- Carrier Material: Artificial or biological material (usually talc or Bacillus spores) used to simulate airborne microbial contamination.
- Challenge Organism: Bacillus subtilis spores used for testing, chosen for their resistance and size similarity to real airborne pathogens.
- Penetration Resistance: The material’s ability to prevent microbes from passing through in dry form, simulating airborne exposure conditions.
If you need help understanding ISO 22612 terms and test configurations, contact us at support@pacificcert.com
Clause-wise Structure of ISO 22612
Clause | Title | Overview |
1 | Scope | Defines the application of the test method. |
2 | Normative References | Lists supporting standards required to conduct the test. |
3 | Terms and Definitions | Establishes terminology used in the method. |
4 | Principle | Describes the mechanism of testing for dry microbial resistance using spores and an air pump system. |
5 | Apparatus | Details the equipment: penetration chamber, air pump, collector units, and microbial recovery system. |
6 | Reagents and Materials | Specifies the use of Bacillus subtilis spores and dry carrier agents. |
7 | Sampling and Test Specimens | Instructions for sample preparation, dimensions, and conditioning. |
8 | Test Procedure | Step-by-step method for performing the dry microbial penetration test. |
9 | Results and Interpretation | Methods for calculating microbial recovery and determining penetration resistance. |
10 | Test Report | Specifies required data for a complete and compliant test report. |
What are the requirements of ISO 22612?
To apply ISO 22612 for testing protective clothing:
- Prepare standardized fabric samples and condition them under specified temperature/humidity.
- Use Bacillus subtilis spores as the microbial challenge with an appropriate dry carrier (e.g talc).
- Place samples in the test chamber where airflow is forced through the material, simulating particle-laden air.
- Collect penetrated microbes on nutrient agar or collection media placed behind the test fabric.
- Incubate, count colonies, and determine penetration performance.
- Perform multiple trials for statistical significance.
If you are planning to test medical or lab clothing under this standard, contact us at support@pacificcert.com
Documentation Required
- Sample identification records
- Fabric specifications and composition
- Microbial strain and culture certificate (Bacillus subtilis)
- Environmental controls (humidity/temperature logs)
- Equipment calibration records (air pump, timers, etc.)
- Colony-forming unit (CFU) test data and photos
- Raw and averaged test results
- Full ISO 22612-compliant test report
- Declaration of Conformity (DoC) if used in regulated markets
If you need help compiling test documentation for ISO certification, contact us at support@pacificcert.com.
What are the benefits of ISO 22612?
- Confirms clothing can prevent dry microbial transfer in healthcare and lab settings.
- Supports broader certification to standards like EN 14126 and ISO 16604.
- Aligns with EU PPE Regulation and WHO infection control guidelines.
- Demonstrates compliance with tender and procurement requirements for hospitals and biosafety labs.
- Strengthens claims for sterile or high-performance bio-barrier clothing.
- Useful for evaluating and improving new material designs in PPE development.
The demand for ISO 22612-tested protective clothing is increasing sharply due to ongoing preparedness for infectious disease outbreaks, such as COVID-19 variants and other airborne pathogens. Hospitals, pharmaceutical manufacturers, and global health organizations are strengthening PPE validation frameworks to ensure garments protect against both wet and dry microbial threats.
There is also growing emphasis on ISO-compliant multilayer fabric systems, nanomaterial coatings, and biodegradable protective garments. ISO 22612 testing, along with related standards like ISO 22610 and ISO 16603/16604, is increasingly used in regulatory submissions, R&D and procurement documentation in high-risk environments.
If your organization requires PPE validation aligned with ISO 22612, contact us at support@pacificcert.com
How can Pacific Certifications help?
Pacific Certifications, accredited by ABIS, offers independent product certification services for protective clothing and PPE standards, including ISO 22612:2005.
We assist with:
- Coordinating product testing at ISO/IEC 17025-accredited labs
- Reviewing technical documentation and test results
- Issuing conformity certificates for regulatory or tender compliance
- Supporting CE marking and global acceptance (where applicable)
- Auditing manufacturing processes if required by client or regulatory bodies
If you are looking for ISO 22612 testing and certification, contact us at support@pacificcert.com
FAQs: ISO 22612
Does ISO 22612 apply to all PPE?
No, it specifically applies to clothing and materials designed to prevent dry microbial penetration, such as surgical gowns and cleanroom garments.
Is this a performance standard or a test method?
ISO 22612:2005 is a test method, not a pass/fail performance standard. It is used as part of broader product evaluations.
What type of organisms are used in this test?
The test typically uses Bacillus subtilis spores, which simulate airborne microbial threats.
Can this be combined with other biobarrier tests?
Yes, it is often used in conjunction with ISO 22610 (wet penetration) and ISO 16604 (viral penetration resistance).
Who can certify products tested to ISO 22612?
Only recognized, accredited bodies like Pacific Certifications can issue certification based on compliant testing and documentation.
Ready to get ISO 22612 certified?
Contact Pacific Certifications to begin your certification journey today!
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