What is ISO 11607-2:2021 ?

ISO 11607-2:2021 is an essential international standard that outlines the key requirements for packaging design and development for medical devices. It is developed by the European Committee for Standardization (CEN) and the International Organization for Standardization (ISO) and aims to ensure the safety and effectiveness of medical devices by maintaining their sterility throughout distribution and storage.

ISO 11607-2:2021 is a harmonized approach to packaging design, which emphasizes the importance of human-centered design to maximize human performance and minimize errors. The standard provides guidelines and requirements for documenting human factor achievements in manufacturing systems design.

Compliance with ISO 11607-2:2021 is crucial for medical device manufacturers to meet regulatory requirements and ensure the safety and efficacy of their products. Packaging serves as a critical barrier that protects medical devices from contamination, damage, and sterility loss.

ISO 11607-2:2021 outlines key requirements for medical device packaging, including material requirements, design requirements, validation requirements, and labeling requirements. It also provides guidance on the design and development of packaging systems that maintain the product's integrity until it reaches the end user.

In conclusion, ISO 11607-2:2021 is an essential international standard that provides guidelines and requirements for packaging design and development for medical devices. Compliance with this standard is crucial for medical device manufacturers to ensure the safety and effectiveness of their products and meet regulatory requirements..