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SRPS EN ISO 11140-1:2009

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

May 20, 2009
95.99   Withdrawal of Standard   May 31, 2011

General information

95.99     May 31, 2011

ISS

Z076

European Norm

11.080.01  

English  

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Scope

ISO 11140-1:2005 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 11140-1:2009
95.99 Withdrawal of Standard
May 31, 2011

REVISED BY

WITHDRAWN
SRPS EN ISO 11140-1:2011

PUBLISHED
SRPS EN ISO 11140-3:2011

Related project

Adopted from EN ISO 11140-1:2005

Adopted from ISO 11140-1:2005 IDENTICAL