The safety requirements for lithium batteries in medical devices cover multiple aspects, including regulatory certification, performance testing, transportation safety, etc. The following is a detailed introduction:
I. Certification Requirements for Major Markets
The US market: It is necessary to comply with core standards such as IEC 62133, UL 2054, IEC 60601-1, and ISO 13485. In addition, the batteries must be biocompatible (ISO 10993-1), pass identity authentication to prevent counterfeiting, and each battery must be serialized and traceable. Batteries need to be submitted to the FDA for registration along with medical devices, and a full test report should be provided. For some high-risk device batteries, additional clinical evaluation data need to be submitted.
Eu market: It is necessary to comply with the "Essential Safety and Performance Requirements" in Annex I of the EU Medical Device Regulation (MDR). The design and manufacture of batteries must be based on the quality management system certified by ISO 13485, and they need to pass tests such as IEC 62133 and IEC 60601-1, and submit a full test report. After certification, the CE mark must be affixed. Batteries for high-risk equipment need to be reviewed by the notified body, while low-risk auxiliary batteries can be compliant through a "self-declaration".
In the Chinese market, general safety requirements must comply with GB 9706.1-2020, lithium primary batteries must comply with GB 8897.4-2008, and lithium rechargeable batteries must comply with GB/T 28164-2011. Starting from August 1, 2024, lithium batteries for portable medical devices will be subject to CCC compulsory certification. Batteries need to be submitted for NMPA registration along with medical devices, providing GB standard test reports and ISO 13485 system certificates. High-risk devices must pass clinical verification.
Transportation safety certification: All medical lithium batteries must pass the UN 38.3 certification. The test contents include height simulation, temperature cycling, vibration test, impact test, etc. The report must be issued by a third-party institution with UN 38.3 testing qualifications. The report must be carried with the goods during transportation.
Ii. Performance and Reliability Testing
Environmental adaptability: It needs to be cycled 50 times from -40 ℃ to + 85℃, with capacity attenuation ≤15%. And tests such as being placed at 40℃ and 95%RH for 168 hours, with insulation resistance ≥100MΩ, etc.
Mechanical reliability: It must pass 26 free drops from a height of 1 meter onto the concrete surface without shell cracking or electrolyte leakage, as well as a bottom impact test simulating the collision scenario of a medical trolley. The insulation resistance is ≥10MΩ.
Electrochemical performance: The battery of the implantable device needs to meet ≥10,000 charge and discharge cycles, with a capacity retention rate of ≥70% and a monthly self-discharge rate of ≤3% (stored at 25℃).
Iii. Adaptation Requirements for Special Scenarios
Implantable equipment: It must pass the ISO 10993-5 cytotoxicity test and ISO 10993-12 extract heavy metal detection. The titanium alloy shell should be laser-welded, and the helium mass spectrometry leak detection rate should be ≤1×10?¹² Pa · m³/s.
Portable devices: They must support fast charging and pass the short-circuit test after fast charging cycles. The battery compartment should be equipped with anti-reverse connection clips, and the casing must be IP67 waterproof.
Emergency equipment: Performance must be maintained under extreme temperatures. For instance, AED batteries need to maintain 90% capacity at -30 ℃ and pass the temperature shock test ranging from -40 ℃ to + 70℃. Defibrillator batteries should provide ≥300J of single discharge energy and have a voltage drop of no more than 5% after five consecutive discharges.
