How It’s Done: Testing Reusable Sharps Containers to ISO Standards
Have your sharps containers been put to the test? Let’s hope so, as it’s the only way they can achieve the ISO standard.
In the healthcare setting, safety and compliance must be proven, not assumed. So when it comes to reusable sharps containers, they need to demonstrate immediate safety and consistent performance over years of reuse.
BS EN ISO 23907-2:2019 is the standard that sets the benchmark for reusable sharps containers, requiring them to undergo rigorous tests, validation processes, and quality checks to ensure that each container remains safe, hygienic, and structurally sound throughout its lifetime.
This article explores the ISO compliance testing process for reusables, what it involves, why it matters, how it differs from the standard for single-use containers, and how it safeguards healthcare workers and patients every single day.
TOPICS WE WILL COVER:
1 / What Is the ISO Standard for Reusable Sharps Containers?
2 / Why Does Compliance Matter?
3 / Who Are the ISO Standards for Reusable Sharps Containers Aimed At?
4 / Why Do Reusable Sharps Containers Require Additional Testing?
5 / Testing Reusable Sharps Containers: What’s Involved?
6 / Sharpsmart: Taking Safety Beyond Compliance
7 / Need Help Raising Waste Disposal Standards in your Facility?
What Is the ISO Standard for Reusable Sharps Containers?
The ISO 23907-2:2019 standard outlines the global requirements for the design, testing and performance of reusable sharps containers intended to hold potentially hazardous sharps clinical waste with or without sharps protection features.
Whereas ISO 23907-1 focuses on single-use containers, part 2 introduces a series of additional requirements and quality tests, including:
- Maintaining structural integrity even after repeated use.
- Resistant to penetration of sharps after reprocessing.
- Undergoing validated cleaning and decontamination ahead of each cycle.
ISO 23907-2 verifies that reusable sharps containers are engineered to protect staff and patients throughout their lifecycle, and guess what? Sharpsmart pioneered the reusable sharps container that set the ISO standard.
Why Does Compliance Matter?
The true cost of a needlestick injury is unquantifiable, meaning that for healthcare facilities large and small, compliance is more than a certification exercise – it’s a safety assurance process.
Testing reusable sharps containers in line with ISO standards closes the gap between design and engineering, minimising the risk of inferior systems entering the market and helping ensure that containers safeguard both clinicians and patients.
Ultimately, the ISO standards for reusable sharps containers protect healthcare workers, aid infection control, and uphold public trust in every clinical setting.
Who Are the ISO Standards for Reusable Sharps Containers Aimed At?
At first glance, you might assume these standards are aimed solely at manufacturers, but that isn’t the case; they apply across the healthcare supply chain, as much for those who build containers as those who buy them. They’re written for:
- Manufacturers and distributors: Providing defined parameters for the testing and validation containers must meet.
- NHS procurement professionals and group purchasing organisations: Providing a reference for specification, safety and compliance during tendering.
- Infection prevention, estates and facilities, and waste management teams: Assuring that the containers used across Trusts meet the same internationally recognised benchmarks.
With compliant systems, healthcare leaders can eliminate ambiguity and be confident they’re meeting the highest safety and hygiene standards for sharps waste management.
Why Do Reusable Sharps Containers Require Additional Testing?
Reusability introduces new risks. Unlike single-use systems, reusable containers must maintain their integrity through every reuse. It would be a disaster to use a germ-ridden sharps container that’s easily broken or punctured.
ISO 23907-2 accounts for this by mandating lifespan simulation, microbial validation, and ongoing performance monitoring. These steps ensure containers are safe, sanitised and sustainable – cycle after cycle.
Testing Reusable Sharps Containers: What’s Involved?
There are numerous design and testing requirements shared by the ISO standards for both single-use and reusable sharps containers, with reusables facing a significantly more demanding testing process.
The shared requirements include:
- An opening that doesn’t allow for hand entry, removal of contents, or the potential for accidental sharps injury.
- An indicator or mechanism to clearly differentiate permanent and temporary closures, and once permanently closed, resistant to manual opening.
- An opening designed to prevent the risk of overfilling, as well as a means for the user to safely ensure that sharps aren’t above the fill line.
And that just highlights a few shared requirements, but what about those specific to reusables?
Lifespan Simulation Testing
Reusable containers should be designed to last through hundreds of cycles – sometimes decades of use. To ensure durability, they undergo lifespan simulation testing that replicates the stresses of real-world handling and reprocessing.
These tests simulate:
- Changes in temperature and environmental exposure.
- Movement and vibration during transport.
- Repeated opening, closing, emptying and cleaning cycles.
Only after these pre-conditioning stages are complete do performance tests begin, proving the container’s strength and stability after it has endured the equivalent of years of clinical service.
Structural Integrity and Penetration Resistance
Following pre-conditioning, containers are tested for their structural integrity and puncture resistance.
For penetration resistance:
- Single-use containers must withstand a penetration force of 16 newtons.
- Reusable containers must withstand 20 newtons – a higher threshold that reflects the demands of repeated use.
[checklist]
But wait… what’s a newton?
A newton is a unit of force (aptly named after the scientist with the famous apple story) that measures the amount of push or pull applied to an object. The greater the force, the higher the number of newtons.
So let’s compare apples with apples:
One newton is roughly the amount of force it takes to lift a small apple (about 100 grams) off the ground. That means an ISO-compliant reusable sharps container must withstand the same pressure as the downward force of 20 small apples – a simple way to picture just how puncture-resistant these containers are.
Additional tests assess:
[checklist]
- Resistance to drops and impact – looking for damage or leaking after drops – in multiple orientations (as opposed to single-use containers only requiring drop tests for containers less than 12 litres in capacity).
- Handle strength under load.
- Topple and spillage resistance.
These tests confirm that the container maintains its protective design throughout its entire lifecycle without compromising clinical safety.
Cleaning and Decontamination Validation
ISO 23907-2 requires reusable containers to be cleaned through automated, validated processes that achieve both visible and microbiological cleanliness. To comply, manufacturers must:
- Use automated washing systems to ensure consistent decontamination.
- Undergo third-party validation before commissioning.
- Implement continuous monitoring to confirm each container meets the established wash parameters.
At Sharpsmart, we achieve this process through our proprietary Washsmart technology. Our automated, multi-stage cleaning system delivers a 6-log reduction in pathogens (far exceeding requirements) and applies our Smartguard anti-soil coating for long-term hygiene performance.
This validation ensures the high-level disinfection of every container returned to service, setting a reusable hygiene standard for the industry.
Microbial Validation Testing
Annex A of ISO 23907-2 details how to validate the microbial efficacy of decontamination – or in layman’s terms, how good your cleaning process is at removing germs. Containers undergo microbial challenge testing to demonstrate that the cleaning process achieves a defined level of sterilisation and disinfection.
This stage confirms that the processed containers are free of viable microorganisms and are as safe to handle as any other clinically sanitised equipment, in support of infection control requirements across NHS facilities.
Post-Decontamination Quality Monitoring
Even after validation, each container must undergo a post-cleaning inspection to confirm it meets safety and hygiene standards before being re-circulated.
Quality checks include:
- Visual inspection for any soiling or wear and tear.
- Verification that each container has been tracked through its wash cycle.
- Confirmation that wash temperature, time and pressure parameters were achieved.
These data-driven quality controls create full traceability and accountability.
Want to know more about ISO 23907-2?
For a more in-depth look at the testing methods and requirements of the standard for reusable sharps containers, our ISO Study Guide is an invaluable resource for anyone responsible for procuring sharps containers for their facility.
Sharpsmart: Taking Safety Beyond Compliance
As the company that set the standard, you’d expect Sharpsmart’s reusable containers to go beyond the baseline compliance, combining engineered safety features with validated cleaning and quality assurance processes. And they do.
For Sharpsmart, meeting ISO requirements is just the starting point – not the finish line.
The safety features of Sharpsmart’s reusable containers include:
- A gravity-balanced safety tray to prevent hand exposure.
- Overfill protection and a tamper-proof lock for secure closure.
- Puncture-resistant ABS polymer proven to withstand clinical demands.
They’re also certified for up to 500 uses, independently validated and proven through peer-reviewed research to reduce needlestick injuries by up to 87%, whilst cutting CO2e emissions by over 80% compared with single-use alternatives.
Explore our full range of safety-engineered reusable waste containers.
Need Help Raising Waste Disposal Standards in your Facility?
Choosing a sharps waste disposal system is an important decision that impacts the safety of your staff and patients, not just your carbon footprint.
Whether you’re replacing outdated systems, responding to compliance audits, or proactively enhancing safety, Sharpsmart offers a clinically designed, fully certified solution.
With Sharpsmart, you get far more than bins and a collection service – not only do we offer a clinically designed, safety-engineered, ISO-compliant solution, but we also work alongside your teams within the four walls of your facility to ensure best practices are established and adhered to.
If you’re ready to learn more about the world’s safest sharps container and how we can help reduce injuries, improve compliance and elevate safety standards within your facility, speak to one of our clinical waste specialists today.
Neil Robinson
Let's Talk!
Your time is valuable, and we don’t want to play hard to get. You can either phone us directly on the details listed on our contact page, or feel free to fill out this short form and one of our team members will get back to you as quickly as possible.