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ILNAS-EN ISO 17665-1:2006 Edition 08/2006
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
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Abstract

ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to: saturated steam venting systems;saturated steam active air removal systems;air steam mixtures;water spray;water immersion.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 204 : Sterilization of medical devices

Directives

90/385/EEC : Active implantable medical devices
93/42/EEC : Medical devices

Implementation

start of the vote on the project    29/07/2004   date of ratification (dor)    14/07/2006
end of the vote on the project    29/12/2004   date of anouncement (doa)    30/11/2006
start of the vote on the final project    13/04/2006   date of publication (dop)    28/02/2007
end of the vote on the final project    13/06/2006   date of withdrawal (dow)    31/08/2009


Publication Official Journal
of the Grand-Duchy of Luxembourg
09/02/2007
Reference

Relations

Evolutions
FprEN ISO 17665

Relations to older standards
ILNAS-EN 554:1994

Relations to international standards
ISO/DIS 17665-1 
ISO 17665-1:2006 
ISO 17665-1:2006 

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

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