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Verification of medical device transportation packaging

With the development of the economy and the improvement of the quality of life of the people, people are paying more attention and attention to health, which has led to the rapid development of the medical industry. Many products in the medical industry involve people's livelihoods and are subject to a lifelong responsibility system. Once the packaging and protection of products are not in place due to transportation reasons, resulting in product failure, the consequences will be unimaginable. Therefore, the control of medical device packaging verification by relevant departments is becoming increasingly strict.

At present, there are relevant requirements for medical device packaging verification in registration and certification both domestically and internationally:

Article 5 of the EU CE MDR regulation Annex I states that the packaging of devices should provide protection during the transportation process, ensuring that their claimed performance cannot be adversely affected after transportation.

The A5 clause of the list of basic requirements for the safety and effectiveness of medical devices in domestic regulations also has similar requirements.

At present, the medical packaging validation standards used include ASTM D4169, GB/T 4857, ISTA 2A, ISTA 3A, ISTA3E, ISTA 3B, etc. Among them, ASTM D4169 and ISTA series standards are mainly used for foreign transportation, and GB/T 4857 series standards are mainly used for domestic transportation.

As a third-party laboratory, ORT has obtained qualifications or authorized recognition from CNAS (China National Accreditation Service for Conformity Assessment), CMA (Inspection and Testing Agency Qualification Certification), ISTA (International Association for Safe Transportation), ASTM (American Association of Materials Laboratories), China Packaging Federation, etc. It can provide customers with a complete set of transportation packaging testing services and technical services. If there are any testing needs or questions, Welcome to contact us!