Essential Performance and Expected Service Life

Essential Performance and Expected Service Life are two of the most misunderstood requirements in 60601-1, Third Edition standard. Here are some tips to help navigate these two topics.

07 September 2012

Essential Performance and Expected Service Life are two of the most misunderstood requirements in 60601-1, Third Edition standard. Here are some tips to help navigate these two topics:

Essential Performance is best defined as performance functions that lead to an unacceptable risk or a risk in the As Low as Reasonably Practicable region. Translation: The testing houses are looking for a Risk Assessment to be completed on the all performance functions to determine which functions lead to essential performance that must be maintained through out the product safety testing.

Expected Service Life is a manufacturer defined term for how long the product will continue to be in compliance with the requirements of the standard. In particular the following all have a tie in to expected service life:

• Clause 5.9.2.3 - Actuating Mechanisms
• Clause 7.1.3 - Durability of Markings
• Clause 7.9.2.15 - Environmental Protection
• Clause 8.6.3 - Protective Earth of Moving Part
• Clause 8.8.4.1 - Mechanical Strength and Resistance to Heat
• Clause 9.8.2 - Tensile Safety Factor
• Clause 11.6.6 - Cleaning and Disinfection of ME Equipment and ME Systems
• Clause 15.3.7 - Environmental Influences

So for whatever expected service life picked for the product, proof needs to be provided to show that the above mentioned items will not fail for that period of time.

Do you have more questions about this topic? If so, please leave a comment below and one of our experts will get back to you.

Todd R. Konieczny, Assistant Chief Engineer, Intertek Americas Region

Tags: Medical Devices | Todd Konieczny