Definition and Example of Shelf life, Expiry date, Expected service life and Lifetime

#1
I'm curious about the definitions for the words below and examples of medical devices that apply.
Thank you in advance for your valuable reply.

1. Shelf life
2. Expiry date
3. Expected service life
4. Lifetime
 
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#2
I'm curious about the definitions for the words below and examples of medical devices that apply.
Thank you in advance for your valuable reply.

1. Shelf life
2. Expiry date
3. Expected service life
4. Lifetime
Hi Kim,
I've found the following definitions.

-Shelf life: the length of time packaged materials can be stored under specified conditions and still remain effective in use (ASTM D996-16)
-Expiry date: date by which product should be used (ISO 11607-1)
-Service life number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and safe for its intended use when used according to the labelling (ISO 11607-1)

No luck with the definition of lifetime.
Hope this help.
 
#3
Taken from IMDRF/GRRP WG/N47 FINAL:2018:

3.13 Expected Lifetime/Expected Service Life: Time period specified by the manufacturer during which the medical device or IVD medical device is expected to maintain safe and effective use.
NOTE 1: The expected lifetime can be determined by stability.
NOTE 2: Maintenance, repairs, or upgrades (e.g. safety or cybersecurity modifications) can be necessary during the expected lifetime.

3.14 Expiry Date/Expiration Date: Upper limit of the time interval during which the safety and performance characteristics of a material stored under specified conditions can be assured.
NOTE 1: This also applies to medical devices whose physical, chemical or functional properties are maintained during a specified and known period, such as for capital equipment.
NOTE 2: Expiry dates are assigned to IVD reagents, calibrators, control materials and other components by the manufacturer, based on experimentally determined stability properties.
(Modified from ISO 18113-1:2009)

3.41 Shelf-Life: Period of time until the expiry date during which a medical device in its original packaging maintains its stability under the storage conditions specified by the manufacturer.
NOTE: Stability (3.38) and expiry date (3.11) are related concepts
(Modified from ISO 18113-1:2009)

3.42 Stability: Ability of a medical device and IVD medical device to maintain its safety and performance characteristics within the manufacturer’s specifications over a specified period of time.
NOTE 1: Stability applies to
- Sterile and non-sterile medical devices whose physical, chemical or functional properties may be altered or compromised over a stated time interval;
- IVD reagents, calibrators and controls, when stored, transported and used in the conditions specified by the manufacturer,
- Reconstituted lyophilized materials, working solutions and material removed from sealed containers, when prepared, used and stored according to the manufacturer’s instructions for use,
- Measuring instruments or measuring systems after calibration.
NOTE 2: Stability of an IVD reagent or measuring system is normally quantified with respect to time and specified conditions,
- In terms of the duration of a time interval over which a measured property changes by a stated amount or
- In terms of the change of a property under specified conditions.
(Modified from ISO 18113-1:2009)
 
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