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prEN ISO 15883-2

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023) prEN ISO 15883-2

Publication date:   Apr 27, 2023

General information

45.99 Dispatch of FV draft to CCMC   Mar 22, 2024

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080.10   Sterilizing equipment

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Draft

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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 legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 15883-2:2009

NOW

IN_DEVELOPMENT
prEN ISO 15883-2
45.99 Dispatch of FV draft to CCMC
Mar 22, 2024