Proregulations Documents Share

Medical device packaging testing is to verify and test the performance of packaging in a laboratory. Registration data for medical and medical products are required to include the results of packaging studies to demonstrate the safety and effectiveness of the contents after delivery, transportation, storage and until use. ISO 11607 requires medical device packaging systems to withstand transport and distribution environments, such as vibration, temperature and humidity, without having any effect on the performance and characteristics of medical devices.