NS-EN 556-1:2024
Current
Current
The latest, up-to-date edition.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Available format(s)
Hardcopy
Language(s)
English
Published date
07-11-2024
Important note : All end users must be registered with an Account prior to user licenses being assigned.This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’.
| Committee |
CEN/TC 204
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 556-1:2024 | Identical |
| EN ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
| EN ISO 11737-2:2020 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) |
| EN ISO 11139:2018 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018) |
| EN ISO 11137-3:2017 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) |
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