Iec 60601 third edition

Once the notice is published, users will have three years to transition to the third edition and the related collaterals and particulars, Herman added. Changes on the Horizon. The CDRH recognition comes as a new amendment to is under development, which includes some changes to the original standard.

One of the proposed changes focuses on extending the scope of to include medical software systems. The amendment includes a definition of medical software systems and associated technical requirements. For example, a dialysis machine intended for use in a clinical setting will have a very different set of risks than a dialysis machine intended for use in a home environment.

Consider the users. In a clinical setting, users of a dialysis machine may be expected to be and reinforced by accompanying documents professionals having education, training and licensing appropriate to the risks associated with such devices.

Additionally, ongoing professional monitoring and availability of personnel to respond to alarms may be anticipated. Contrast this with a home setting, where users may not have a medical background, and may have cognitive or physical limitations.

Alarms and responses to alarms may also not be as timely as in a clinical setting. Although the risks associated with the above considerations and others may be addressed by a device manufacturer, a home environment poses unique challenges as compared to a clinical setting.

The next step is to define what the manufacturer expects the product to do from a clinical standpoint. For example, the product may be used to diagnose a disease or other conditions; or the product may be used in the cure, mitigation, treatment, or prevention of disease; the product may also affect the structure or function of the body. Once the clinical function of the product is established, it becomes possible to define the essential performance. One way of doing this is to ask, what would happen to the patient if the product did not perform the clinical function as specified?

Is there a risk of harm? Of course, this must consider degraded performance of the product as well, e. With these foundational elements in place, all later steps of the risk management process will follow.

A detailed specification of the intended use of a product establishes the contextual boundaries for risk identification. Essential performance defines the device functions that must be preserved in all circumstances of normal and abnormal use. Amendment 1 to the 3rd Edition of IEC went a long way to addressing and clarifying the many implementation questions that arose from the ambitious and far-reaching 3rd Edition standard.

Manufacturers are still coming to terms with the impact of all these changes, which are now being enforced in stages by regulators around the world. He is responsible for developing new services and training, and he represents UL on international standards and other technical development committees.

Leimbeck has worked with UL for over 30 years in a variety of roles, including operations manager and principal engineer for multiple product categories. The rewrite clarifies that a full ISO assessment and post-production monitoring are not required for compliance.

Essential Performance Subclause 4. In addition to these changes, essential performance is now a test criteria in assessing if a hazard is present after a specific test. Humidity Subclause 5. Documentation Clause 7 A number of new documentation requirements for user manuals and instructions for use IFU have been added. In addition, electronic versions of all accompanying documentation must apply the usability engineering process as covered in the collateral standard, IEC , Usability, in determining what information must be presented.

Marking and Labeling Subclause 7. Electrical Hazards Clause 8 There are a number of changes related to protections from potential electrical hazards, including defibrillation protection, protective earth and creepage and clearance distances.

There are new limits for leakage current testing for functional earth connections. Protective earth testing with a power supply cord is required for devices equipped with appliance inlets.

Permanently installed equipment must include a power lockout device if reconnection presents a potential hazard to a user. Mechanical Hazards Clause 9 Testing for mechanical hazards related to instability and mobile equipment has been modified to include functional testing.