GOST EN 556-1-2011
Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices

Standard No.

GOST EN 556-1-2011

Release Date

2011

Published By

RU-GOST R

Latest

GOST EN 556-1-2011

GOST EN 556-1-2011 Referenced Document

• EN ISO 13485:2000 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001 Revision of EN 46001:1996; Identical to ISO 13485:1996
• EN ISO 13488:2000 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 Revision of EN 46002: 1996; Identical to ISO 13488: 1996; Superseded by EN ISO 13485:2003

GOST EN 556-1-2011 history

• 2011 GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices