The third edition of IEC60601-1 ISO13485 will have a great impact on medical device manufacturers and certification organizations, but it will also ensure that medical devices are safer and more effective.

All those involved in IEC60601-1 certification must be aware that there are considerable differences between the second edition (1988) and the third edition (2005) of the standard. Apart from the structural changes to the standard, The third edition contains a wider range of products, and at the same time, taking into account the technological development in the past ten years, different standard development methods have been adopted to better meet the needs of the times.

In the third edition of ISO 13485, certain medical devices can relax the testing requirements based on past records, thereby significantly reducing the cost of medical devices. For example, if the risk management process shows that a device or its parts will not be exposed to disease. patients, the device or part only needs to comply with IEC60950, as in this case its primary purpose is to protect the operator and not the patient. Manufacturers who encounter this situation can use IT applications in their products parts, such as power supplies and displays.

Introducing a new way of thinking

Perhaps the most instructive change in the third edition is the provision of "risk management". Clause 4.2 of the third edition states that a risk management process that conforms to the ISO 14971 specification must be performed. In other words, the third edition must be met. It must comply with ISO14971.

The statement incorporates procedural provisions into the testing ISO 13485 standard and thus has a significant impact on manufacturers and certification organizations (COs). Everywhere in the third edition it uses the manufacturer's risk management process to determine whether a particular specification is applicable or not. ､ Whether alternative regulations can be adopted, or whether so-called alternative test standards or procedural requirements can be met.

Flexibility of risk management standards

Clause 4.5 of the third edition allows manufacturers to use alternative methods to manage the risks set out in the ISO 13485 standard, as long as it can be demonstrated that the "residual risk" in the product (estimated from the risk management process) is lower than that specified in the standard. , Risk management is not used to design products that can comply with the third edition, but to design a set of standards that equipment must meet.

It might be an exaggeration to say that this is an innovative idea, but in fact, the risk management process does give manufacturers more flexibility. However, because of this flexibility, manufacturers must demonstrate that they can bear the risk assessment. , taking into account the applicable regulations and ISO13485 standards, the interests of the parties and state-of-the-art processes. The so-called "risk tolerance" needs to be well-founded and measurable so that manufacturers can make decisions at the design stage. Correct decision.

IMPACT ON CERTIFICATION ORGANIZATIONS

What does the development of a risk management process mean for the certification organization? Depending on the intended use of the product and the ultimate risk tolerance, the test parameters of each device, and even the application of specific tests, will vary. So, the question that follows Yes, how this will affect the cost and energy efficiency control of the certification organization when performing the test. Also, because there are over a hundred declarations of conformity in the third edition, all of them must have risk management documents to provide evidence of conformity, so Certification organizations must review most, if not all, of the manufacturer's risk management documentation. As a result, the necessary documentation for ISO 13485 certification may increase substantially.