Under the European Union (EU) Battery Regulation 2023/1542, released last year, all medical device and in-vitro diagnostic device (IVD) manufacturers are required to comply with the regulation starting 18 August 2024. Portable batteries that are generally utilized by medical devices and IVDs are defined as “sealed, weighing 5kg or less, and not intended for industrial use”.
Hence, batteries must be categorized to determine the appropriate routes for conformity assessment. Manufacturers are required to compile technical documentation to support compliance, issue a Declaration of Conformity (DoC), and affix the CE marking.
Performance and Durability Requirements for Rechargeable Industrial Batteries, LMT Batteries, and Electric Vehicle Batteries
Per Article 10 of the Regulation, all rechargeable industrial batteries with a capacity exceeding 2kWh, light means of transport (LMT) batteries, and electric vehicle batteries must display electrochemical performance and durability parameter values. Further details can be found in Annex IV of the Regulation.
Safety of Stationary Battery Energy Storage Systems
Manufacturers or responsible persons must ensure the technical documentation referred to in Annex VIII shall:
Provide evidence that stationary battery energy storage systems comply with paragraph 1, including successful safety tests, parameters, and state-of-the-art testing methodologies used
The safety assessment must encompass successful safety tests, mitigation strategies, and methodologies for addressing potential safety hazards not included in Annex V
Include instructions for mitigation in the event of identified hazards
Information on the State of Health and Expected Lifetime of Batteries
The battery management system for stationary battery energy storage systems, LMT batteries, and electric vehicle batteries must contain updated data on the parameters for determining the state of health and expected lifetime of batteries as outlined in Annex VII
Read-only access to these parameters through the battery management system must be provided on a non-discriminatory basis to the legal owner of the battery, including independent operators, waste management operators, or any third party acting on their behalf. This access must respect the intellectual property rights of the battery manufacturer and is intended for purposes such as:
Making the battery available to independent aggregators or market participants for energy storage
Assessing the residual value or remaining lifetime of the battery, including its potential for further use based on the state of health estimation
Facilitating the preparation for re-use, repurposing, or remanufacturing of the battery
Software reset function must also included in the battery management system to allow economic operators involved in re-use, repurposing, or remanufacturing to upload different battery management system software. If the software reset function is used, the original battery manufacturer shall not be held liable for any safety or functionality breaches attributed to the new software uploaded after the battery was placed on the market
Medical device and IVD manufacturers must ensure that the batteries used in their devices comply with regulations and that both the batteries and medical devices or IVDs have separate CE markings.
Source: European Union (EU)
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