Validation of autoinjectors

What is the purpose of validating autoinjectors in accordance with ISO 11608-1?

Autoinjectors are highly sensitive medical devices that must function precisely, reliably, and safely in an emergency. Validating autoinjectors ensures they meet the requirements of ISO 11608-1. This international standard specifies the safety, reliability and performance criteria that autoinjectors must meet. It establishes a consistent framework for manufacturers and users, ensuring long-term patient safety and facilitating the successful acquisition of regulatory approvals.

Our testing laboratory is currently still in the process of obtaining accreditation for the validation of autoinjectors.

What happens during the validation of auto-injectors in accordance with ISO 11608-1?

As part of this process, auto-injectors undergo a variety of test procedures. These tests ensure that the systems function correctly and achieve the required quality under realistic conditions. We can carry out the following tests for you:

Dosing accuracy
Performance testing in cold, normal and warm environments
Service life test
Free fall test
Testing during storage in dry heat, cold and humid heat
Cyclical climate test
Vibration test
Transport simulation
Functional stability
Influence of fluid leakage
Inspection: legibility of markings and freedom from defects

This validation provides manufacturers and users with the assurance that their systems comply with the requirements of ISO 11608-1 and meet internationally recognised standards.

In which areas is the validation of autoinjectors used?

Validation in accordance with ISO 11608-1 is an essential part of quality assurance in healthcare. Typical areas of application include:

The pharmaceutical industry: verification of the safety and performance of injection systems for drug administration
Medical technology manufacturers: development, optimisation and approval of new pen injectors and accessories
Testing and certification bodies: performance of conformity tests in accordance with international standards
Clinical applications: ensuring that autoinjectors can be used reliably and safely by patients in everyday life.

Validation in accordance with ISO 11608-1 thus plays a key role in ensuring patient safety, facilitating the market approval of new products, and fostering confidence in modern injection systems.

Validation of autoinjectors inquiry