Compliance Standards for Reusable Sharps Containers
Your one-stop hub for all things BS EN ISO 23907-2:2019 – the ultimate compliance standard for reusable sharps containers.
Shared ISO Requirements for Both Types
All sharps containers – whether single-use (Part 1) or reusable (Part 2) – must meet key safety benchmarks to achieve ISO compliance.
- Restricted access design: The container aperture must prevent hand entry and unauthorised removal of contents.
- Overfill protection: The design must mitigate the risk of overfilling and provide a clear, visible fill line.
- Secure closures: Permanent and temporary closure mechanisms must be clearly differentiated. Once locked, the permanent closure must resist manual reopening.
- Penetration resistance: All containers must meet minimum force resistance during testing:
- 16 newtons for single-use
- 20 newtons for reusable containers
Additional ISO Requirements for Reusable Containers
Because reusable containers are designed for repeated use over several years, ISO 23907 Part 2 introduces more stringent performance and hygiene standards.
- Lifecycle testing: Simulated wear and tear through drop tests and repeated transport/processing cycles ensures performance durability throughout the container’s lifespan.
- Automated cleaning standards: Cleaning must be validated microbiologically, automated, and continuously monitored to ensure hygienic reuse.
- Microbial efficacy validation: Containers must undergo rigorous decontamination efficacy testing as outlined in Annex A of the standard.
- Post-wash quality assurance: Each container must be quality checked after decontamination to verify cleanliness and structural integrity before being reintroduced to clinical environments.
Explore More: Understanding ISO Testing for Reusable Sharps Containers
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Sharps Container Compliance FAQs
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