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SRPS EN ISO 15883-2:2011

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)

May 31, 2011
95.99   Withdrawal of Standard   Jul 31, 2025

General information

95.99     Jul 31, 2025

ISS

Z076

European Norm

11.080.10  

English  

From plan 2011

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Scope

ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1.
The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

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.

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

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 15883-2:2009

NOW

WITHDRAWN
SRPS EN ISO 15883-2:2011
95.99 Withdrawal of Standard
Jul 31, 2025

REVISED BY

PUBLISHED
SRPS EN ISO 15883-2:2025

Related project

Adopted from EN ISO 15883-2:2009

Adopted from ISO 15883-2:2006 IDENTICAL