BS EN 556-2:2015

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 90/385/EEC on
         active implantable medical devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices
Annex ZC (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 98/79/EC on in
         vitro diagnostic medical devices
Bibliography

Describes the requirements for an aseptically processed medical device to be designated 'STERILE'.

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.