Identification of the correct World Health Organisation (WHO) Performance, Quality and Safety (PQS) product category and applicable specifications for syringes, needles and safety boxes. The activity clarifies relevant performance criteria, documentation expectations and acceptance limits before testing begins, ensuring that products are evaluated against the correct WHO PQS framework for immunisation devices.
Mechanical and environmental testing
Syringe and safety box testing service for compliance
Looking for syringe and safety box approval for safe, reliable use in global vaccination programmes? Use a WHO-approved laboratory.
Testing of syringes and safety boxes shows compliance with the World Health Organisation's Performance, Quality and Safety (WHO PQS) standards. The evaluation covers performance, durability and material integrity to confirm that your products meet the requirements for WHO pre-qualification and safe use in vaccination programmes.
Manufacturers of vaccination syringes and devices
This service is part of a suite of mechanical and climatic test services. It's ideal for manufacturers and suppliers of syringes and safety boxes used in vaccination programmes. To be eligible for WHO and UN procurement, these products must be pre-qualified and listed in the WHO PQS database. Meeting these standards requires documented proof of performance, safety and material consistency. Design or material changes can cause failures during retesting, delays in approval, and costly supply interruptions. The testing programme meets all the necessary standards and provides clear documentation.
Challenges
Potential bottlenecks related to WHO PQS standards and maintenance of device quality
Complex WHO PQS requirements delay approval
WHO PQS categories and specifications are highly technical. Misinterpretation can lead to incorrect product classification or unmet requirements, delaying approval.
High documentation burden slows compliance progress
Test documentation and traceability requirements require extensive time and technical input. Without sufficient resources, gaps in records can undermine confidence in compliance.
Production changes introducing regulatory risk
Design changes during production can affect device performance and compliance.
Inconsistent evidence blocks regulatory acceptance
ISO and EU Medical Device Regulation (MDR) compliance requires independent test results that go beyond WHO PQS documentation alone.
Benefits
Get testing to secure clear approval and consistent device quality
Verified WHO PQS compliance
Our testing demonstrates conformity with World Health Organisation (WHO) Performance, Quality and Safety (PQS) standards, helping manufacturers gain pre-qualification for global vaccination programmes.
Traceable documentation, easier audit preparation
Our structured reports provide clear, traceable evidence of compliance and quality, simplifying WHO, UN and regulatory audit reviews. You have clear documentation that reduces bottlenecks.
Comprehensive test scope, long-term market access
Testing in accordance with WHO PQS, ISO, and European MDR standards supports both pre-qualification and continuous compliance across international markets. Your long-term performance is bolstered.
