DPS
Drejtoria e Përgjithshme e Standardizimit
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN ISO 11140-1:2009

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

Dec 22, 2009
95.99 Withdrawal of Standard   Oct 29, 2015

General information

95.99     Oct 29, 2015

DPS

DPS/KT 206

European Norm

11.080.01  

English  

Buying

Withdrawn

Language in which you want to receive the document.

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

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

NOW

WITHDRAWN
SSH EN ISO 11140-1:2009
95.99 Withdrawal of Standard
Oct 29, 2015

REVISED BY

PUBLISHED
SSH EN ISO 11140-1:2014

Related project

Adopted from EN ISO 11140-1:2009