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  • BSI
    BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated \"STERILE\" - Requirements for terminally sterilized medical devices
    Edition: 2024
    $318.72
    / user per year

Description of BS EN 556-1:2024 2024

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.

Standard NumberBS EN 556-1:2024
TitleSterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
StatusDefinitive
Publication Date2024-07-03
ReplacesBS EN 556-1:2001
Identical National Standard OfEN 556-1
DescriptorsMarking, Sterile equipment, Medical instruments, Quality assurance, Quality control, Sterilization (hygiene), Medical equipment, Microorganisms
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 539 22681 2
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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