Lithium ion cells and batteries used in portable medical electrical equipment—General specification
1Key Takeaways
This document specifies the terminology and definitions, requirements, test methods, quality assessment, labeling, packaging, transportation, and storage for lithium-ion batteries and battery packs used in portable medical electrical equipment. It applies to lithium-ion batteries and battery packs that enable portable …
2Expert Interpretation
Interpretation of the SJ/T 12275-2026 standard, covering terminology, requirements, test methods, quality assessment, and labeling, packaging, transportation, and storage for lithium-ion batteries and battery packs used in portable medical electrical equipment. Applicable to monitoring, therapeutic, and diagnostic equipment, emphasizing safety and performance indicators.
Standard Overview and Scope of Application
SJ/T 12275-2026 "General Specifications for Lithium-Ion Batteries and Battery Packs for Portable Medical Electrical Equipment" is an electronic industry standard issued by the Ministry of Industry and Information Technology and managed by the China Electronics Standardization Institute. This standard applies to lithium-ion batteries and battery packs that support the intended use of portable medical electrical equipment (such as electronic sphygmomanometers, heart rate monitors, nebulizers, portable ECG machines, etc.), but excludes active implantable medical devices and their dedicated external components. The standard clarifies terminology, requirements, test methods, quality assessment procedures, and labeling, packaging, transportation, and storage requirements for batteries and battery packs.
Key Terminology and Definitions
The standard defines 20 key terms, including medical electrical equipment, portable medical electrical equipment, lithium-ion batteries, lithium-ion battery packs, nominal voltage, charging limit voltage, discharge termination voltage, rated capacity, rated energy, reference test current, charge retention capability, recovered capacity, energy-type batteries/battery packs, power-type batteries/battery packs, leakage, venting, rupture, ignition, explosion, and type testing. These terms lay the foundation for understanding subsequent performance requirements and test methods.
Performance Requirements and Test Methods
The standard specifies specific indicators for the electrical performance, environmental adaptability, and safety of batteries and battery packs, and prescribes corresponding test methods. The following is a summary table of major performance indicators:
| Performance Indicator | Requirement (Battery/Battery Pack) | Test Conditions |
|---|---|---|
| Initial Capacity | Not less than rated capacity | 23℃±2℃, 0.2It discharge |
| High-Temperature Capacity | ≥99%/95% of initial capacity | 55℃ or manufacturer-specified maximum discharge temperature, 0.2It discharge |
| Low-Temperature Capacity | ≥70% of initial capacity | -20℃±2℃ or manufacturer-specified minimum temperature, 0.2It discharge |
| Rate Discharge (Energy Type) | ≥90% of initial capacity | 1It discharge |
| Rate Discharge (Power Type) | ≥85% of initial capacity | 3It discharge |
| Charge Retention Capability | ≥90% of initial capacity | Storage at 20℃±5℃ for 28 days, 0.2It discharge |
| Recovered Capacity | ≥90% of initial capacity | Storage at 20℃±5℃ for 1 year, measured after charging and discharging |
| Cycle Life (Battery) | ≥500 cycles (capacity ≥80% of initial) | 20℃±5℃, capacity check every 50 cycles |
| Cycle Life (Battery Pack) | ≥400 cycles (capacity ≥80% of initial) | 20℃±5℃, capacity check every 50 cycles |
| AC Internal Resistance | Not higher than manufacturer-specified | 1kHz frequency, measurement of RMS voltage and current |
| Safety | No ignition, explosion, leakage, etc. | Throughout all test processes |
Test Conditions and Quality Assessment
The standard specifies test environmental conditions as temperature 20℃±5℃, relative humidity ≤75%, and atmospheric pressure 86kPa~106kPa. Parameter measurement tolerances are strict: voltage ±0.2%, current ±1%, temperature ±2℃, time ±0.1%, capacity ±1%. The charging program for testing adopts manufacturer-specified methods or the standard constant current-constant voltage method. Samples shall be representative. The quality assessment procedure includes type testing, with test items covering all performance requirements. The number of samples is specified in Table 2, and the judgment rule requires all items to be qualified.
Labeling, Packaging, Transportation, and Storage
Labeling for batteries and battery packs must be clear, including product name, model, rated capacity, rated energy, charging limit voltage, nominal voltage, polarity, manufacturer, production date, or batch number. Packaging should be moisture-proof and dust-proof. Transportation should avoid severe vibration and compression. Storage conditions are -5℃~35℃ with relative humidity ≤75%.
Significance and Application of the Standard
This standard provides unified technical specifications and testing basis for lithium-ion batteries used in portable medical electrical equipment, helping to ensure the safety and reliability of medical devices, promote product quality improvement, and facilitate standardized industry development.