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BSI 23/30457243 DC 2023

BSI 23/30457243 DC 2023

$13.70

BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated “STERILE” – Part 1. Requirements for terminally sterilized medical devices

Published By Publication Date Number of Pages
BSI 2023 16
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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.

PDF Catalog

PDF Pages PDF Title
7 1 Scope
2 Normative references
3 Terms and definitions
9 4 Requirements
10 Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
13 Annex ZB (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered

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BSI 23/30457243 DC 2023
$13.70