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)
