DANSK DS/EN 556-2

Name:
DANSK DS/EN 556-2 PDF

Published Date:
09/25/2015

Status:
[ Active ]

Description:

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

Publisher:
Dansk Standard

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

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.

Edition :	15
File Size :	1 file , 850 KB
Number of Pages :	18
Product Code(s) :	DS-017, DS-017
Published :	09/25/2015

History

DANSK DS/EN 556-2

Published Date: 09/25/2015

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

$15.3

DANSK DS/EN 556-2

Published Date: 01/29/2004

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

$11.4

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