With the rapid development of medical device industry, lithium battery, as an important power source of medical equipment, has been paid more and more attention to its safety and performance stability. Aiming at the safety management of batteries containing alkaline or other non-acidic electrolyte, the Chinese national standard GB/T 28164-2011 came into being, providing scientific standards for the production, detection and use of lithium batteries for medical devices. This article will focus on GB/T 28164 standard, introduce its content, significance and guiding role for manufacturers of lithium batteries of medical devices, and help enterprises and industry practitioners to fully understand and implement this standard.

I. INTRODUCTION to GB/T 28164 standard

GB/T 28164-2011 standards are all called "general safety specifications for batteries and a galvanic battery containing alkaline or other non-acidic electrolyte". This standard is jointly issued by China General Administration of national quality surveillance examination quarantine and China National Standardization Management Committee, aiming at regulating the design, manufacture, testing and use of batteries containing alkaline or other non-acid electrolyte, ensure its safety and reliability.

The standard covers different types of storage battery, including nickel-cadmium, nickel-hydrogen, lithium-ion batteries, etc., especially for the safety of batteries in special fields such as medical devices. Lithium battery, as a key component of medical equipment, the formulation and implementation of its safety standards are particularly important.

II. Core content of GB/T 28164 standard

1. scope of Application </span>
   this standard is applicable to batteries and a galvanic battery containing alkaline or other non-acidic electrolyte, especially battery products used in medical devices, communication equipment, portable electronic products and other fields.

2. Safety Design Specification
   the standard requires that battery design must consider safety measures such as short circuit prevention, overcharge prevention, overdischarge protection and temperature control. High quality materials and advanced technology should be adopted in the design process to ensure the long-term safe operation of the battery.

3. Performance test requirements
   including battery capacity, internal resistance, cycle life and safety performance test. Special emphasis is placed on the safety performance detection of the battery under extreme conditions such as overcharge, short circuit, impact, extrusion and high temperature to ensure that the battery will not explode or catch fire under abnormal conditions.

4. Identification and description
   it is stipulated that battery products must clearly mark the model, specification, maximum charging voltage, capacity, production date and safety warning information, which is convenient for users to use and maintain correctly.

5. Quality control and inspection
   manufacturers are required to establish a perfect quality management system, strictly control raw material procurement, production process and finished product inspection, and ensure that each batch of products meet the standard requirements.

III. Significance of GB/T 28164 standard to manufacturers of lithium batteries for medical devices

1. improve Product Security
   

2. Standardize production process
   this standard provides scientific production guidance for manufacturers, covering design, material selection, process control and inspection links, helping enterprises to establish standardized production systems and improve manufacturing quality and efficiency.

3. Promote market recognition
   products conforming to GB/T 28164 standards are more easily recognized by medical device regulatory authorities and enhance market competitiveness. At the same time, the implementation of standards is also conducive to the brand building of manufacturers and the trust of customers.

4. Support technological innovation
   the high requirements of the standard for safety performance promote manufacturers to continuously optimize battery design and technical improvement, promote continuous innovation and upgrading of lithium battery technology, and meet the ever-increasing needs of the medical industry.

IV. Practical suggestions of manufacturers of lithium batteries for medical devices

1. in-depth understanding of standard requirements
   manufacturers should organize professional teams to deeply study GB/T 28164 standard content, and formulate design and production plans that meet the standards according to their own product characteristics.

2. 
   establish a perfect quality management system, from raw material procurement, production process to finished product inspection, implement the whole process quality control to ensure stable and qualified products.

3. Focus on security testing
   strengthen the safety performance test of the battery, especially the safety verification under extreme working conditions such as overcharge, short circuit, mechanical impact, etc., to ensure the reliability of the product.