SR EN 556-2:2016

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

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), 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.

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General information

Status : Withdrawn
Approval date : 2/29/2016
Romanian version publish date : 10/31/2018
Withdrawal date : 5/31/2025
Number of pages : 20
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 556-2:2004
Normative reference SR EN ISO 17665-1:2007
Normative reference SR EN ISO 13485:2016
Normative reference SR EN ISO 11137-1:2015
Normative reference SR EN ISO 13408-2:2011
Normative reference SR EN ISO 20857:2013
Normative reference SR EN ISO 14937:2010
Normative reference SR EN ISO 25424:2011
Normative reference SR EN ISO 14160:2011
Normative reference SR EN ISO 13485:2016/AC:2016
Normative reference SR EN ISO 13408-5:2011
Normative reference SR EN ISO 11135:2014
Normative reference SR EN ISO 13485:2016/AC:2018
Replaced by SR EN 556-2:2025