Definition Lifetime of the Medical Device - What is the most appropriate definition?

N

nick lekanides

#1
if the device is listed with a 5 year lifetime or warranty, and we continue to repair and refurbish devices well past this date, does this change the lifetime of the device?
what would the most appropriate definition for "lifetime of the medical device" be?
what is the best way of determining the lifetime of the device?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: what is the "lifetime of the medical device"?

One example definition is the one from the new IEC 60601-1 standard:

EXPECTED SERVICE LIFE
maximum period of useful life as defined by the MANUFACTURER
Keep in mind that, if the manufacturer specifies a 5 year lifecycle (it´s the common word used, not lifetime), and you act on the device past this date, for some regulations you´ll be the new manufacturer of the device and will have to comply to regulations (and also define a new expected service life)

The best way of determine the service life of the devices is through reliability analysys and tests.
 
Q

QA-Man

#3
Re: What is the most appropriate definition for "Lifetime of the Medical Device"?

The lifecycle of the device is everything from the design and development of the device to the decommisioning or proper disposal of the device.

The lifetime of the device could be how long you expect the device to be functional (expected lifetime) A device may last longer than its lifetime but your organization may continue to service it (usually for a fee).
 

DannyK

Trusted Information Resource
#4
Re: What is the most appropriate definition for "Lifetime of the Medical Device"?

From ISO 14969 section 7.1.3, the rational for the Lifetime could be as follows:

a. Shelf life of the medical device​
b. Expiry date of the medical device​
c. Number of cycles or periods of use of the medical device​
d. anticipated material degradation​
e. stability of packaging material​
f. for implantable devices, the residual risk that results from the entire period of residence of the device in the body​
g. for sterile devices, the ability to maintain sterility​
h. organization's ability to support service​
i. spare parts cost and availability​
j. legal considerations including liability​
 
A

arrabellaangel

#5
May i know what is the difference between shelf life of medical device and expiration date of the medical device?
 
M

MIREGMGR

#6
Sterile devices commonly have an expiration date, related to the time period over which the sterile-barrier-packaging system has been validated to maintain the device's sterility in conjunction with the mechanical handling that the packaged device may experience.

If the device has a shelf life consideration, or any other lifetime consideration, that lifetime must be longer than the labeled expiration date. The device must be safe and effective if used prior to the labeled expiration-date, assuming that the sterile barrier packaging is integral up to the moment of package-opening for device use.

Non-sterile devices frequently have a defined shelf life, beyond which they shall not be used. This might be related to a conservative determination of materials degradation, for instance.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
If the device is non-sterile, re-usable and the lifetime is determined to be five years, does that have to go on the label or is the IFU sufficient?
"Have to"...? You didn't specify a regulatory context - country/region (of distribution/use), class, type of device etc.
 
Thread starter Similar threads Forum Replies Date
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
P Regarding lifetime of a Medical Device EU Medical Device Regulations 7
qualityegghead ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
D Lifetime of the Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 2
G Maintaining of Performance during the Lifetime of a IIa Medical Device EU Medical Device Regulations 5
A Medical Device Handling AFTER the device's specified lifetime has expired 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Justification of Lifetime of a Medical Device including Component Aspects ISO 13485:2016 - Medical Device Quality Management Systems 13
E Defining the lifetime of an Implantable Medical Device Other Medical Device and Orthopedic Related Topics 5
J Requirements for Documenting Lifetime of a Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
L Shelf-Life vs. Lifetime of Medical Laser Device Other Medical Device and Orthopedic Related Topics 4
A Manufacturer Obligation to Declare the Lifetime of its Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 12
T Defining Product Lifetime - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 5
T Defining the lifetime of medical devices - long lasting parts such as bone screws. ISO 13485:2016 - Medical Device Quality Management Systems 3
K Expected lifetime of the device-Article 18 EU Medical Device Regulations 4
K Article 18 in the Implant Card - Expected lifetime of the device EU Medical Device Regulations 3
I Lifetime Support Calculation - Thermal Operating Profile Reliability Analysis - Predictions, Testing and Standards 7
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
M Capturing Issues of Devices Past Lifetime Nonconformance and Corrective Action 3
T Reliability Lifetime Requirement Demonstration Test Reliability Analysis - Predictions, Testing and Standards 3
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
P Smoky Mountains - Extreme/Adrenaline/Once in a Lifetime Experience Travel - Hotels, Motels, Planes and Trains 15
K Equipment Lifetime: Put in operation manual or a individual document/declaration Quality Manager and Management Related Issues 1
P Annex 1, ER 4 ...product lifetime must be declared along with..." EU Medical Device Regulations 9
A Requirement 4 of MDD 93/42/EEC - Definitions of Lifetime, Life Cycle, Shelf Life EU Medical Device Regulations 5
E Definition Product Lifetime - Including ISO 13485 Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
R How to define Product Lifetime - IVD instruments (no reagents) - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Gore to Get Lifetime Award - Webby Award for online achievements After Work and Weekend Discussion Topics 7
C The lifetime of a light bulb Coffee Break and Water Cooler Discussions 36
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Electrical Medical Devices class I EU Medical Device Regulations 0

Similar threads

Top Bottom