Verfallsdatum
The use-by date is the last day on which a medical device may be used as intended according to the manufacturer. The corresponding hourglass symbol is standardised in EN ISO 15223-1; the declaration is mandatory under MDR (EU) 2017/745 Annex I Chapter III for products with a limited shelf life.
Format: stated as YYYY-MM-DD or YYYY-MM. Where the day is omitted, the last day of the stated month applies.
Determination: for medical single-use gloves the date is established through ageing testing to EN 455-4, either by real-time storage or by accelerated ageing with Arrhenius conversion. Three to five years is typical.
Scope: the use-by date applies only where packaging is intact and the stated storage conditions have been observed. Damaged sterile packaging voids sterility immediately, regardless of the date. The use-by date must be strictly distinguished from the date of manufacture.
Frequently asked questions
What does the hourglass symbol on glove packaging mean?
The hourglass symbol under EN ISO 15223-1 marks the use-by date. Up to that point the manufacturer guarantees the declared product properties and, for sterile products, sterility, provided packaging is intact and storage conditions were met.
What applies when only year and month are given?
Where the use-by date is stated as YYYY-MM, the last calendar day of that month is the expiry date. The product may therefore be used up to and including the end of the month.
May gloves still be used after the use-by date?
No. After expiry the manufacturer's guarantee for tested properties such as leak-tightness and force at break no longer applies. For sterile products the sterility guarantee also lapses. Continued use is not covered by the regulatory framework.