Medical device batteries serve as the core power source for medical equipment, ranging from portable monitoring devices to emergency equipment, all relying on their stable support. The GB28164 standard, officially known as "Safety Requirements for Alkaline or Other Non-acidic Electrolyte Batteries and Battery Packs - Portable Sealed Batteries", is specifically designed to set the core indicators such as electrical safety, thermal safety, and mechanical performance for portable batteries used in medical devices. It is an important basis for ensuring the stable operation of medical equipment.
Obtaining the GB28164 report is not an unnecessary step; rather, it is a dual guarantee of compliance and safety. On one hand, the GB9706.1 2020 standard explicitly references its requirements, and without this report, it will affect the registration and listing of medical device products. On the other hand, the report can verify the safety of the battery in scenarios such as overcharging, short circuiting, and dropping, reducing risks in medical use and enhancing customer trust, laying the foundation for market expansion.
To apply for the report, you need to prepare the following materials in advance: product manual and technical parameter table, battery samples (quantity provided according to the testing requirements), application letter, copy of the business license of the enterprise, product component list and BOM table. Ensuring the completeness of the materials can accelerate the processing progress.
The processing procedure is simple and efficient, with no need for cumbersome travel: 1. Consultation and coordination to clarify testing requirements; 2. Submit the above materials and samples; 3. The laboratory conducts full-item testing according to the standards; 4. After passing the inspection, the report is compiled and reviewed; 5. Electronic and paper reports are issued.
The GB28164 report for medical device batteries is the "passport" for product compliance and listing, and also the "shield" for medical safety. Zhonglian Ke Li has authoritative qualifications of CNAS and CMA, and a professional team deeply engaged in the field of testing. They can efficiently handle the report processing and provide professional services to ensure the compliance of your products and safeguard their market entry. If you need to apply for it, please feel free to consult at any time, and let professional services help your products enter the market smoothly!
