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SSH EN 556-2:2015

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

Mar 29, 2016

General information

60.60     Mar 29, 2016

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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Scope

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.

Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
more
93/42/EEC

Medical devices

Harmonized
more
98/79/EC

In vitro diagnostic medical devices

Harmonized
more

Life cycle

PREVIOUSLY

Replaces
SSH EN 556-2:2005

NOW

PUBLISHED
SSH EN 556-2:2015
60.60 Standard published
Mar 29, 2016

Related project

Adopted from EN 556-2:2015

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