SS-EN-556-2 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

SS-EN-556-2 - 2015 EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)


Active implantable medical devices. Medical devices. In vitro diagnostic medical devices

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

IEC-60529
Degrees of protection provided by enclosures (IP Code)

ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

ORDER

Price:

$118.95        


Want this as a site license?



Designation Name

SS-EN 556-2:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

Sept. 16, 2015

Language(s)

English

Page Count

28

International Equivalent

EN 556-2:2015(IDT)