What is ISO 11135-1:2016 ?

What is ISO 11135-1:2016?

ISO 11135-1:2016 is a technical standard that provides guidelines for the design and testing of autoinjectors for medical use. It is an essential tool for ensuring the safety, reliability, and quality of these devices.

The primary aim of ISO 11135-1:2016 is to establish a set of requirements for autoinjectors that cover various aspects, such as compatibility with different medications, accurate dosage delivery, ease of use, reliability, and safety. By adhering to this standard, manufacturers can develop autoinjectors that meet these essential criteria and deliver safe and effective drug delivery to patients.

Key Requirements of EN ISO 11135-1:2016

ISO 11135-1:2016 provides several key requirements for manufacturers to follow when designing and testing their autoinjectors. These requirements are as follows:

Compatibility: The device must be compatible with different medications and be able to deliver a specific dose of medication.

Accurate Dosage Delivery: The device must be able to deliver a precise amount of medication to the patient.

Ease of Use: The device must be easy to use and intuitive for the user.

Reliability: The device must be reliable and able to function correctly even in challenging environments.

Safety: The device must be safe and minimize the risk of injury or harm to the patient.

By following these key requirements, manufacturers can develop autoinjectors that are safe, effective, and of high quality. This ensures that patients receive the right amount of medication and minimal harm.

EN ISO 11135-1:2016 is a professional technical standard that focuses specifically on the design and functionality of injectors. It is widely recognized worldwide and provides a framework for manufacturers to develop safe and effective autoinjectors for medical use.