BS EN 556-1:2024

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Sterilization of medical devices. Requirements for medical devices to be designated “STERILE” – Requirements for terminally sterilized medical devices

Published By	Publication Date	Number of Pages
BSI	2024	20

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Categories: 11.080.01 - Sterilization and disinfection in general, BSI

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Description

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.

Additional information

Status	Definitive
Pages	20
Publication Date	2024-07-03
ISBN	978 0 539 22681 2
Standard Number	BS EN 556-1:2024
Title	Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" – Requirements for terminally sterilized medical devices
Identical National Standard Of	EN 556-1
Replaces	BS EN 556-1:2001
Descriptors	Marking, Sterile equipment, Medical instruments, Quality assurance, Quality control, Sterilization (hygiene), Medical equipment, Microorganisms
Publisher	BSI
Committee	CH/198
ICS Codes	11.080.01 - Sterilization and disinfection in general

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BS EN 556-1:2024

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