FAQ: Risk Management for IEC 60601-1

What you need to know about Risk Management for medical devices

What is Risk Management in 60601?

Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The risk management process is meant to identify, quantify and mitigate risks that may be present in all settings of intended use, reasonably foreseeable misuse and conditions of a product or system.

Why is a risk management system implemented?

For medical devices, a specific risk management process must be performed due to the wide ranges of equipment types, intended uses and usage environments. These different risks based on usage factors are evaluated using the risk management process to determine if the potential hazards to patients, operators or the environment are effectively mitigated.

Risk consideration when evaluating medical products considers a wider range of hazards, as the intended use of medical products can represent risks outside the traditional shock, burn, chemical, etc. hazards. For example, a pacemaker’s failure may directly cause heart failure. The risk of heart failure caused by the pacemaker must also be mitigated to an acceptable level during the risk management process for medical equipment.

What are the main risk management considerations?

Essential Performance – This determines what component or system operation is absolutely critical to patient care. If these parts of the product fail, it can cause severe harm to patients that can result in injury or death (unacceptable risk). Essential performance is most easily understood by considering whether its absence or degradation would result in an unacceptable risk.

Intended Use – This determines the operations and environments a product is intended to be used for in the field. Manufacturers are responsible for documenting clear operational instructions and acceptable environments for a product. Intended use provides context for likely/possible product misuses and therefore risks that must be considered during a product’s actual use.

Patient Needs – This determines why a product is used. By correctly identifying the patient need, manufacturers can design safeguards based on the principle of care. The principle of care helps manufactures accurately classify the severity of potential risks based on the severity of the patient need.

Who is responsible for risk management?

Manufacturers are exclusively responsible for planning, performing and documenting the risk management process. The criteria for identifying potential risks and determining acceptable levels of risk are determined and evaluated by manufacturers to prove acceptable levels of risk. The risk management process IS NOT audited on-site to prove compliance. Instead, compliance to the risk management portion of 60601-1 is evaluated by a certification body by using the reviewing documentation of the risk management process contained in the risk management file.

How do I compile a risk management file?

A risk management file is used to document all risks and their severity for review by a certification body. The risk management file should be developed in accordance with ISO 14971 and include the following documentation:

  • Risk Management Plan
  • Risk Analysis
  • Risk Evaluation
  • Risk Controls
  • Evaluation of Overall Risk Responsibility
  • Risk Management Report
  • Production and Post-production Risks

About MET

MET Laboratories certifies or tests medical electrical equipment for Product safety compliance in the United States and Canada, EMC compliance, FDA Guidance Documents and consensus standards necessary for FDA clearance, including IEC 60601, AAMI and ASTM standards, Electrical wheelchairs to the ANSI/RESNA/FDA and European EN 12184 requirements. MET is the first NRTL licensed by OSHA for medical equipment. OSHA regulations cover all workplaces, which include hospitals, clinics, therapy centers, and similar facilities. MET-certified medical products have been universally accepted in the US and Canada.