Quick insights
- Both EN 14563 and EN 14348 evaluate mycobactericidal and tuberculocidal efficacy of chemical disinfectants
- EN 14348 is a phase 2 step 1 quantitative suspension test
- EN 14563 is a phase 2 step 2 carrier test performed on contaminated carriers
- Both standards use Mycobacterium avium and Mycobacterium terrae as test organisms
- Test data is used by manufacturers to support performance claims for regulatory submissions.
Summary
While comparing EN 14563 vs EN 14348, it is important to understand that both test methods assess mycobactericidal and tuberculocidal efficacy but serve different purposes within the disinfectant validation process. EN 14348 provides efficacy data through a suspension test, whereas EN 14563 evaluates performance using carriers.
What are EN 14563 and EN 14348?
European standards EN 14348 and EN 14563 were established to assess whether disinfectants can effectively inactivate these challenging microorganisms.
Understanding EN 14563 vs EN 14348 helps manufacturers select the appropriate validation test for their products. Both standards focus on mycobactericidal and tuberculocidal activity, but they differ vastly in procedure, real-world use simulation, and intended application during product development
EN 14348 evaluates efficacy in a liquid suspension, whereas EN 14563 evaluates efficacy on carriers representing contaminated instrument surfaces.
Why is mycobactericidal testing important?
Mycobacteria are considered to be one of toughest bacteria to destroy.
Their cell wall structure contains large amounts of lipids and wax-like compounds making them highly resistant against chemical disinfectants. Because of this strong resistance, demonstrating mycobactericidal activity is often a strong indicator of a disinfectant’s overall performance.
Disinfectants play a key role in breaking the chain of transmission, particularly in healthcare environments, where contaminated instruments and surfaces can cause spread of infections.
However, efficacy cannot be validated based on formulation alone. Standardized tests such as EN 14348 and EN 14563 are established to confirm whether a disinfectant can effectively inactivate mycobacteria under controlled and practical-use conditions.
Effective mycobactericidal testing is important for:
- Medical device disinfectants
- Instrument disinfectants
- Healthcare disinfectants
- High-level disinfectants
- Infection prevention products
Why surrogate mycobacteria are used
Surrogate mycobacteria species (Mycobacterium terrae) are used in disinfectant testing since they safely simulate high resistance of pathogens like Mycobacterium tuberculosis without causing any severe health risks to people involved in testing.
EN 14348 explained
What is EN 14348?
EN 14348 is a quantitative suspension test used to evaluate the mycobactericidal and tuberculocidal activity of chemical disinfectants and antiseptics used in medical areas.
The test verifies whether a disinfectant can acquire the required microbial reduction level under defined laboratory conditions.
Test type
EN 14348 is phase 2 step 1 quantitative suspension test
Test microorganisms
Mandatory test organisms are:
- Mycobacterium terrae
How the test works
- Test sample is added into solution of test microorganisms and interfering substance.
- The mixture is allowed to interact for a specified period of time
- Post the contact time, neutralization is performed
- The neutralizing extract is plated and incubated
- After incubation, bacterial colonies are enumerated and results are compared with controls
Advantages of EN 14348
- Effective screening – The test allows manufacturers to quickly assess multiple formulations during product development.
- Standardized test conditions – The test is performed under highly standardized and reproducible test conditions.
- Useful for R&D – EN 14348 is often used by formulation scientists to optimize disinfectant composition before progressing to more complex studies.
Limitations
Although highly useful, EN 14348 has limitations.
- The test evaluates microorganisms in suspension rather than on contaminated surfaces.
- Hence, passing EN 14348 does not always guarantee same level performance in practical use conditions
Passing criteria for EN 14348
To pass the EN 14348 test, the test product must achieve at least 4-log reduction in the mycobacterial count.
Also check
EN 14563 explained
What is 14563?
EN 14563 is a quantitative carrier test used to evaluate the mycobactericidal and tuberculocidal activity of chemical disinfectants intended for instruments used in medical areas. Unlike suspension tests, this method uses microorganisms dried onto carriers for disinfectant exposure.
Test type
EN 14563 is a phase 2 step 2 quantitative carrier test
Test microorganisms
Mandatory test organisms include:
- Mycobacterium avium
- Mycobacterium terrae
How the test works
- Test suspension is mixed with an interfering substance and spread onto sterile glass plate
- Inoculated glass slides are allowed to dry out, kept in a container containing test products fro a specific contact time
- At the end of contact time, glass slides are neutralized
- The neutralizing extract is plated and incubated
- After incubation, bacterial colonies are enumerated and results are compared to controls
Advantages of EN 14563
- Better practical simulation – The test provides more valid evidence on the performance of disinfectant in practical use conditions.
- Drying stage – This step involves drying microorganisms onto a carrier surface before treating with disinfectant. This closely represents contamination in real-world.
Passing criteria for EN 14563
To pass the test, test product must achieve a minimum of 4 log reduction under specified conditions
EN 14563 vs EN 14348: Key differences
| Parameter | EN 14348 | EN 14563 |
| Test type | Suspension test | Carrier test |
| Test phase | Phase 2 step 1 | Phase 2 step 2 |
| Surface drying stage | Not required | Required |
| Mandatory test organisms |
|
|
| Scope of products | Disinfectants used in Healthcare facilities, public and community spaces, Medical devices and other areas | Disinfectants used in hospitals, Community care centres, Dental care settings, Nursing homes and laundries providing services to patients |
| Log reduction | A minimum of 4 log reduction | A minimum of 4 log reduction |
Similarities between EN 14563 vs EN 14348
Test organisms
Both test methods use:
- Mycobacterium avium
- Mycobacterium terrae
Scope of application
Both test methods are useful for disinfectants used in medical and healthcare settings.
Test conditions
Both test methods use:
- Temperature – 20
- Contact time – 60 minutes
- Interfering substance – 0.3 g/l bovine albumin solution (Clean conditions), 3.0 g/l bovine albumin solution+ 3.0 ml/l erythrocytes (Dirty conditions)
Supporting mycobactericidal and tuberculocidal claims
EN 14563 and EN 14348, both support data generation related to mycobactericidal and tuberculocidal efficacy claims.
Why do manufacturers perform both tests?
Manufacturers often evaluate EN 14653 vs EN 14348 during product development as both methods provide information under different test conditions.
Performing both tests helps manufacturers in:
- Generating broader efficacy data
- Assessing performance in suspension and carrier setup
- Substantiating decisions during product development
- Meeting customer or regulatory expectations
- Evaluating products used in healthcare settings
Common applications of EN 14563 and EN 14348
Both test methods are applicable for disinfectants used in:
- Hospitals
- Dental care facilities
- Nursing homes
- Community care settings
- Laundries and kitchens providing services directly to patients
How MIS supports Mycobactericidal and tuberculocidal testing
At MIS, our expert microbiology team provides comprehensive mycobactericidal and tuberculocidal testing in accordance with test methods such as EN 14348 and EN 14563.
Our experts provide assistance in choosing the right test method for your product, performing rigorous testing to generate valid, reliable and reproducible results. To discuss your testing needs, contact our experts today.
Read more
- EN 13727 vs EN 1276: Key Differences in Disinfectant Testing
- Difference Between EN 1276 and EN 14476
- Why EN 1276 is Important for Regulatory Compliance
FAQs
1. Do manufacturers need both EN 14348 and EN 14563?
The appropriate test or combination of tests depends on disinfectant’s intended use, product claims, and applicable regulatory expectations. However, some manufacturers perform both studies to obtain efficacy data under different testing conditions
2. Which test is better represents practical disinfection conditions?
EN 14563 uses carriers and a drying stage before disinfectant exposure, which better represents real-world use conditions.
3. How is a suspension test different from a carrier test?
A suspension test evaluates microorganisms suspended in a liquid environment, whereas a carrier test evaluates microorganisms deposited and dried on a defined surface before disinfectant exposure
4. Which microorganisms are used for these tests?
These tests use Mycobacterium avium, Mycobacterium terrae as mandatory test organisms
5. What is tuberculocidal activity?
Tuberculocidal activity refers to the ability of a disinfectant to inactivate mycobacteria used to support efficacy claims associated with tuberculosis-related organisms as defined within applicable standards
6. Can instrument disinfectants be tested under both standards?
Yes, depending on the intended claims, instrument disinfectants may be evaluated using both EN 14348 and EN 14563
7. Can disinfectant wipes be tested using EN 14348?
No, EN 14348 is a suspension test and generally isn’t considered suitable for disinfectant wipes
