This battery pack information, including manufacturing information, is stored, together with the results of the outgoing testing, in a separate external secured database. The traceability of the individual cells, the assembled PCBA, and the relevant battery pack production data, is therefore ensured (see Figure 3).

Logistics. Before lithium-metal or Liion cells and battery packs can be transported, they must be tested according to the UN38.3 testing method for transport. When this test is passed, the battery packs are marked accordingly with the UN symbol (see Figure 4). For the transport of Li-ion batteries, the correct packaging, package size, and quantity must be observed. Only Li-ion packs marked with the UN symbol may be transported. Without this marking, a transport permit is required.

Quality Assurance in the Marketplace

Fig. 7 – RBRC promotes recycling of Li-ion batteries.

After the batteries enter the market in finished medical devices, quality assurance measures continue. A complaint management system according to the requirements of ISO 13485 guides this process.

All complaints related to batteries from the market are analyzed. For this, the frequency of the individual error indication is analyzed. For each error indication, the error causes are determined via an 8D error report (a structured corrective action process), which initiates correctional or preventative and improvement measures. The errors most commonly identified during analysis are “Ichikawa” and “5W” error codes.

The actions for improvement follow the PDCA (plan, do, check, act) cycle, a systematic series of steps for the continual improvement of a product or process, also known as the Deming Cycle (see Figure 5).1 In addition, the error risk and its effect on persons and property must be assessed for each error. Finally, market observations help all manufacturers in recognizing and preventing errors before their own products or the battery packs in their devices display these errors.

Environmental considerations. With an increase in environmental awareness and the impact of batteries on the environment, a functioning environmental management system is becoming more important than ever. Batteries contain a variety of chemicals and are toxic to the humans, wildlife, and the environment. Manufacturers of Li-ion battery packs and their production processes are checked to determine whether they comply with the current quality management standards (e.g., ISO 14001) and regulations (e.g., RoHS, REACH). In addition, the issues of ecological balance and the carbon footprint must be taken into account in the manufacture of Li-ion batteries.

In the EU, entities that put batteries on the market are obliged to take them back and must inform consumers where and how they can dispose of batteries for recycling. Li-ion batteries must be marked with the WEEE (Waste of Electrical and Electronic Equipment) label (represented by a crossed-out garbage bin) as well as with the Li-ion recycling symbol.

Furthermore, each country has its own recycling and statutory environmental requirements, which must be met. For Europe, these are the Restriction of Hazardous Substances (RoHS) Directive 2002/95/EC, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, and the Battery Directive (2006/66/EC). For China, the China RoHS directive applies. Figure 6 shows an example of a battery with various country approvals and recycling symbols.

U.S. manufacturers follow the EU’s RoHS Directive. Also in the United States, the Rechargeable Battery Recycling Corporation (RBRC), a nonprofit organization dedicated to rechargeable battery recycling, has launched the Call2Recycle program with more than 30,000 Call2Recycle drop-off locations throughout the United States and Canada (see Figure 7). More than 175 manufacturers and marketers of portable rechargeable batteries and products fund the Call2Recycle program to help prevent rechargeable batteries from entering the solid waste stream.

Social responsibility. The United States is considered the pioneer in social responsibility. In 2010, the United States set new requirements for the minerals used in products, based on the OECD “Due Diligence Guidance” within the meaning of social responsibility.2 The regulation was codified in the Dodd-Frank Wall Street Reform and Consumer Protection Act – Conflict Minerals. All companies that commit to this regulation declare that the minerals tantalum, tin, tungsten, and gold that are used in their products (components) do not originate from the countries Democratic Republic of the Congo, Angola, Burundi, Central African Republic, Republic of the Congo, Rwanda, South Sudan, Tanzania, Uganda, or Zambia. Many U.S. and globally active companies have committed to the Dodd-Frank Act.


Development, design, testing, producing, and delivering a high-quality Li-ion battery pack requires a commitment to and an embracement of quality assurance. By following the guidelines above, companies can move toward developing exceptional products that are also safe and environmentally friendly. Moreover, batteries that meet these stringent requirements are suitable for integration into medical devices from neurostimulators and other implantables to portable monitors and infusion pumps.


  1. Deming, W.E.: Out of the Crisis. Massachusetts Institute of Technology, Cambridge 1982, ISBN 0-911379-01-0, S. 88.
  2. OECD (2013), OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas: Second Edition, OECD Publishing. ISBN 978-92-64-18501-2 (print), ISBN 978-92-64-18505-0 (PDF)

This article was written by Ulrich Sonndag, director of corporate quality, QMR, for RRC Power Solutions GmbH, Homburg, Germany. For more information, Click Here .

Medical Design Briefs Magazine

This article first appeared in the February, 2017 issue of Medical Design Briefs Magazine.

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