MEEE Expected Service Life - IEC 60601-1 Clause 4.4 Requirements



Dear all,

I have a brief question with regards to the IEC 60601-1 Clause 4.4 "expected service life". For the Tools we are recommending a yearly service to ensure that the device (handheld motor driven drill/saw) are functioning as intended.

But I'm still struggling with the correct definition of the expected service life of these devices. Is this the time frame the device is functioning without any service has been performed (so one year would be the expected service life), or is this the time frame the device can be serviced and therefor the functionality can be ensured (here we are talking about several years)?

What is your definition of the "expected service life"? Are in your eyes the expected service life and the lifetime of the device talking about the same time frame?

Thanks a lot for your help,



Inactive Registered Visitor
In fact, it's the time frame that the device the manufacturer created the device to work safely and thus is related to the regulatory responsibility the manufacturer has on the device lifecycle.

Peter Selvey

Super Moderator
The lifetime is simply what you want, there is no need to justify why you selected, for example 3, 5 or 7 years. Mainly it will have a marketing and cost impact, longer to make your device look better value, shorter saves on costs for quality of parts. But it's not a safety driven figure, just economics and sales.

Once selected, though, it becomes an important input for safety related decisions, which is why it has to be declared in the risk management file. For example, if you need to judge whether a protection system is reliable, you will need to know the lifetime of the equipment in order to make a decision. A protection system for a device with 3 years life might be OK as is, but the same protection in a device with 15 years life might need periodic checking to make sure it's still effective over the lifetime.


Thanks for your comprehensive answers.
Following your explanations, would it be ok to label a 5year expected service life/lifetime and informing the customer through the IFU/Product Labeling that a regular service (e.g. yearly) is needed to ensure that the labeled service life can be reached?
Or do I need to label the expected service life for one year and renew it as soon as the yearly service has been performed?
Product reliability is tested for one year in our internal product develpment tests.

Peter Selvey

Super Moderator
In IEC 60601-1, there is no requirement to label the device with the service life, or even mention it in the instructions for use (as far as I can tell).

The key point in IEC 60601-1 is to declare it in the risk management file, so it can then be used for safety related decisions.

I guess there is the potential for "expected service life" to get mixed up with warrantee or guarantee etc which are purely commercial matters. So for this reason IEC 60601-1 does not require it to be declared to the end user.
Thread starter Similar threads Forum Replies Date
B How much staff input into the QMS is expected? Quality Manager and Management Related Issues 6
G Verification of Expected Service Life: Max # Reprocessing Cycles IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K Definition and Example of Shelf life, Expiry date, Expected service life and Lifetime EU Medical Device Regulations 6
G Lifecycle / Expected Service Life of Steel Parts Other Medical Device and Orthopedic Related Topics 5
DuncanGibbons Potential causes of Young's (Elastic) Modulus to be half what is expected for alloy? General Measurement Device and Calibration Topics 6
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
D Tolerance definition based on expected Cp/cpk Reliability Analysis - Predictions, Testing and Standards 14
K Expected lifetime of the device-Article 18 EU Medical Device Regulations 4
R Expected life span of Medical devices - X-Ray based diagnostic medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
K Article 18 in the Implant Card - Expected lifetime of the device EU Medical Device Regulations 3
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
K How to define Expected life service life of medical device Other Medical Device Related Standards 4
qualprod Is a Corrective Action Expected if a Quality Objective is not in compliance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
P What is expected in a Medical Device Commercial Release Procedure Design and Development of Products and Processes 3
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
R Medical Device, Warranty Influences Expected Service Life Reliability Analysis - Predictions, Testing and Standards 3
pittmatj Are New Brazil Class I Medical Device Regulations Expected? Other Medical Device Regulations World-Wide 10
R Are ISO 9001 certificates delivering confidence in line with the expected outcomes? Registrars and Notified Bodies 2
T Expected release date for ISO 50003? Sustainability, Green Initiatives and Ecology 3
somashekar 7 Major changes expected in ISO14001:2015 ISO 14001:2015 Specific Discussions 3
W What kind of data is expected for a PPAP Material Analysis Report IATF 16949 - Automotive Quality Systems Standard 7
K Time Expected to Invest in SPL (Structured Product Labeling) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Setting Expected Service Life for an an Electrical/Electronic Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 24
D ECG Electrodes - Duration of Use (How long they are expected to stay on the patient) Other US Medical Device Regulations 2
V Supplier CA Request - Do you include a letter explaining what is expected of them? Supplier Quality Assurance and other Supplier Issues 14
J SR-001 Revision - Keep watching for the new revision of SR001 (It is expected soon) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
N Are Overload Test Results expected to be maintained through out Life of Product? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K What is the expected length, content of a Food Safety Manual? Food Safety - ISO 22000, HACCP (21 CFR 120) 7
E Identifying the Elements of Informed Consent expected by the IRB and FDA Other US Medical Device Regulations 4
Sidney Vianna Joint IAF-ISO Communique' - Expected Outcomes of Accredited Certification ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
S New TS 16949 release expected in January 2009 IATF 16949 - Automotive Quality Systems Standard 65
S Potential Changes to BS EN 9001:2000 expected in October 2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Expected Service Life of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 3
K Best practices on the criteria to issue CAPA & expected response time? Preventive Action and Continuous Improvement 2
S Attribute GRR - Cross tab - Kappa - What does "Expected Count" mean? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Expected Process Maps - Requirement to somehow document how these processes work? Process Maps, Process Mapping and Turtle Diagrams 20
B Continual Improvement Requirements - No expected completion date listed - 8.5.1 IATF 16949 - Automotive Quality Systems Standard 10
M How Many Expected Defective Assemblies? Six Sigma 1
R Making sense of Standard Hours - Work an employee can be expected to do in an hour Manufacturing and Related Processes 12
Marc Definition Expected "overall" performance - Definition - Process Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Performance - Expected "overall" performance - From Minitab Using Minitab Software 5
J Help with Mintab concepts: Expected "overall" performance vs. Observed performance Six Sigma 5
A Is it time to remove the constraints under which registrars have been expected to operate? General Auditing Discussions 20
K ISO 14001:2004 - 4.3.2 Legal & Other Requirements - Level of detail expected ISO 14001:2015 Specific Discussions 18
M Attribute MSA-CrossTab Study Example in MSA Manual:How to compute the Expected Count? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
apestate Custom hardware product - What acceptable quality level (AQL) is expected in the US? AQL - Acceptable Quality Level 4
R Update of ISO 14000 - Finalization Expected in 2004 Miscellaneous Environmental Standards and EMS Related Discussions 14
Howard Atkins Expected Values for EV, AV etc in a GRR Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11

Similar threads

Top Bottom