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IEC 60601-1-9 Environment Testing  Medical electrical equipment

IEC 60601-1-9 Environment Testing

Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

IEC 60601-1-9 Introduction:

The objective of IEC 60601 1 9 and EN 60601 1 9 testing is to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle:

  • Product specification;
  • Design;
  • Manufacturing;
  • Sales, logistics, installation;
  • Use;
  • End-of-life management.

This means protecting the environment and human health from hazardous substances, conserving raw materials and energy, minimizing the generation of waste, as well as minimizing the adverse environmental impacts associated with waste. The criteria needed to reach this goal must be integrated into all stages of the medical electrical equipment life cycle from the specification stage to end-of-life management.

The environmental impacts of medical electronic equipment through all life-cycle stages are determined from the medical electrical equipment’s environmental aspects defined during the identification of need, product planning, and design stages (see Table A.1). Consideration of environmental aspects as early as possible in these stages can produce numerous benefits that might include lower costs, stimulation of innovation and creativity, and increased knowledge about the product. It can also provide new business opportunities, improved product quality, and a reduction of adverse environmental impacts. The assessment of the environmental aspects and impacts of medical electrical equipment is a developing science and it is anticipated that this collateral standard will require periodic updating as the science develops.

The requirements given in IEC 60601-1-9 do not replace national or international laws and regulations. Environmental protection is one element of the overall risk management process as required by the general standard.

The acceptability of medical electrical equipment’s environmental impacts is balanced against other factors, such as the product’s intended function, performance, safety, cost, marketability, quality, legal and regulatory requirements. This balance can differ depending on the intended function of the medical electrical equipment. For example, a solution appropriate for life-saving or life-supporting medical electrical equipment might not be appropriate for a device intended to correct a minor ailment. A manufacturer of medical electrical equipment might have to justify, as a result of risk management, that a medical benefit outweighs the associated adverse environmental impacts.

Keystone Compliance assists manufacturers with IEC 60601-1-9 and EN 60601-1-9 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-1-9 test lab needs.