With the development of the economy and the improvement of the quality of life of the people, people pay more attention to health, which has led to the rapid development of the medical industry. Many products in the medical industry are related to people's livelihood and are lifelong responsibilities. Once the packaging protection product is not in place due to transportation reasons, the product fails, the consequences will be unimaginable. Therefore, relevant departments have become more and more stringent in the management and control of medical device package testing verification.
At present, domestic and foreign registration and certification all have relevant requirements for medical device packaging verification: Article 5 of the EU CE MDR Regulation Annex I mentions: The packaging of the device must protect the device during the transportation process to ensure that the device is transported. The declared performance cannot be adversely affected. The A5 clause of the list of basic requirements for the safety and effectiveness of medical devices in domestic regulations also has similar requirements.
The medical package testing standards adopted at this stage are ASTM D4169, GB/T 4857, ISTA 2A, ISTA 3A, ISTA3E, ISTA 3B, etc. Among them, the ASTM D4169 and ISTA transit testing series of standards are mainly used for foreign transportation, and the GB/T 4857 series are mainly For domestic transportation.
As a third-party laboratory, ORT has been authorized and accredited by CNAS (China National Accreditation Service for Conformity Assessment) and ISTA (International Safe Transport Association). It can provide customers with ASTM D4169, GB/T 4857, and ISTA standard test services. , If you need any assistance, please contact us!