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BSI 23/30457240 DC 2023

BSI 23/30457240 DC 2023

$10.54

BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE” – Part 2. requirements for aseptically processed medical devices

Published By Publication Date Number of Pages
BSI 2023 20
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This document 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), designating that a medical device is ‘STERILE’ is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7.

PDF Catalog

PDF Pages PDF Title
7 1 Scope
2 Normative references
8 3 Terms and definitions
10 4 Requirements
4.1 Validation and routine control
13 4.2 Compliance
4.3 Documentation and records
14 Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
17 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 23/30457240 DC 2023
$10.54