How to Comply with EN 556-1:2024
SN EN 556-1:2024
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
About SN EN 556-1:2024 at a glance
SN EN 556-1:2024 specifies the requirements for medical devices to be classified as 'STERILE' through terminal sterilization processes. Published by CEN and aligned with EU regulations, this standard aims to ensure the safety and effectiveness of sterilized medical devices in the European market. This FAQ addresses common inquiries on how to comply with EN 556-1:2024, including validation of sterilization procedures and routine monitoring processes.
Related topics
Consider exploring these related areas:
- Other clauses of SN EN 556-1:2024
- Sister standards such as EN ISO 11135 and EN ISO 17665-1
- Training opportunities for compliance with sterilization standards
- Guidance on the impact of EU Regulation 2017/746 on medical businesses.
Get the standard or training
To gain a deeper understanding of the requirements and processes associated with EN 556-1:2024, consider purchasing the standard or booking a training session. This will equip you with the knowledge needed for compliance in your organization.