When you are developing Respiratory Protective Equipment (RPE), testing can feel like one single hurdle: pass the test, get the approval, launch the product.
In reality, there are two very different types of testing that manufacturers should understand: pre-approval testing and type approval testing. They are related, but they are not the same thing. One helps you learn, improve and de-risk the product before the final stage. The other forms part of the formal route to market.
Understanding the difference can save time, reduce cost and prevent the painful situation of finding a major design issue when you are already deep into the approval process.
What is pre-approval testing?
Pre-approval testing is carried out before the formal approval stage. 
It is not about “testing for the sake of it”. It is about using reliable test data during development so that you can understand how your product is performing, where the risks are, and what may need to change before you commit to formal approval testing.
For RPE manufacturers, this can be extremely valuable. A product may look close to completion, but small design or material choices can have a big effect on performance. Pre-approval testing can help identify issues such as:
- particle filter penetration performance not meeting the intended classification
- breathing resistance being higher than expected
- inward leakage risks linked to face seal or fit
- robustness concerns, such as harness strength or connection points
- performance differences between sizes, variants or materials
Finding these issues early is far better than finding them during formal approval testing. At the pre-approval stage, there is usually still time to adjust the design, test different options and improve the product without creating major delays.
What is type approval testing?
Type approval testing is part of the formal conformity route.
This is the testing used to demonstrate that a final product type meets the relevant requirements of the applicable standard or regulation. In simple terms, it is the evidence-gathering stage that supports the approval of a specific product design.
By the time a product reaches type approval testing, the design should be mature. The materials, construction, performance claims, user instructions and technical documentation should all be aligned.
The aim is not to experiment. The aim is to confirm that the product meets the required performance and safety criteria.
For manufacturers, this is a high-stakes stage. If the product fails at this point, the consequences can be significant: redesign, new samples, updated documentation, repeat testing, delayed certification and a slower route to market.
The key difference
The simplest way to think about it is this:
Pre-approval testing helps you understand whether the product is ready. Type approval testing helps demonstrate that the final product meets the required standard.
Pre-approval is a development tool. Type approval is a formal approval tool.
Pre-approval gives you space to ask questions:
- Is the design performing as expected?
- Which design variable is causing the issue?
- How much margin do we have against the requirement?
- What happens if we change the material, flow rate, filter media or face seal?
- Are all sizes and variants performing consistently?
Type approval answers a different question: Does this final product type meet the applicable requirements?
Both are useful, but they are useful at different points in the product journey.
When do you need pre-approval testing?
You should consider it when:
- you are developing a new RPE product
- you are changing materials, components or suppliers
- you are scaling from prototype to production
- you have multiple sizes or variants to compare
- you need confidence before committing to formal approval
- previous test results have been inconsistent
- you want to reduce the risk of late-stage failure
It can also be useful when internal testing has taken the product as far as it can. Many manufacturers are very good at early feasibility work in-house, but there comes a point where external, accredited data becomes more useful.
An ISO 17025 accredited laboratory brings controlled methods, calibrated equipment, traceability, measurement uncertainty and independent technical competence. That means the data is more defensible, more repeatable and more useful for decision-making.
When do you need type approval testing?
You need type approval testing when the product is ready to enter the formal approval route.
At this point, you should be confident that:
- the product design is final or very close to final
- the applicable standard has been identified
- the intended classification is clear
- samples are representative of production
- technical documentation is in progress or complete
- user information and product markings are aligned
- the manufacturer is ready to support the approval process
Type approval testing should not be treated as a development exercise. It is possible to learn things during formal approval, but that is not the ideal time to discover fundamental performance issues.
If the product fails at this stage, the route forward is usually slower and more expensive than if the same issue had been found earlier through pre-approval testing.
Why pre-approval can make type approval smoother
Pre-approval testing does not replace type approval, but it can make the type approval process more predictable.
It does this by reducing uncertainty.
When a product has already been tested under comparable conditions, the manufacturer has a clearer understanding of its performance margins. There are fewer surprises. If an issue does arise, the earlier data can help with root cause analysis because there is already a performance history to work from.
This can reduce the number of retest loops and help avoid unnecessary redesigns.
For example, if breathing resistance is higher than expected, pre-approval testing may help identify whether the issue is linked to filter media, airflow design, valve performance or another variable. Without that data, it is much easier to make the wrong change and lose time.
A practical way to use both
The most effective approach is not to test everything formally from day one.
A better route is often:
- Early internal screening. Use your own team for fast feasibility checks, prototype comparisons and early design decisions.
- Targeted pre-approval testing. Use an accredited laboratory when the product is getting closer to final design and you need reliable, externally credible data.
- Final type approval testing. Move into formal approval once the design is mature, the documentation is aligned and the product is ready to be assessed against the applicable requirements.
This approach keeps development moving quickly while still using accredited testing at the points where it adds the most value.
Summary
Pre-approval testing and type approval testing are both important, but they serve different purposes.
Pre-approval testing is about learning before the stakes are too high. It helps manufacturers identify risks, improve the design and make better decisions before formal approval.
Type approval testing is about demonstrating that the final product type meets the relevant requirements. It is a formal step in the route to market and should ideally confirm what you already believe to be true.
For RPE manufacturers, the biggest mistake is often leaving too much discovery until the type approval stage.
Used early and with a clear scope, ISO 17025 accredited pre-approval testing can reduce late failures, shorten investigation cycles and give manufacturers greater confidence before entering formal approval.
If you have a development project or a new product on the horizon, Global Compliance Services can help you plan the right testing route, from targeted pre-approval work through to type approval testing. Why not get in touch to discuss your requirements.