EN ISO 15883-2:2009

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) EN ISO 15883-2:2009

Publication date:   Jun 17, 2010

General information

60.60 Standard published   Jun 3, 2009

CEN

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

European Norm

11.080.10   Sterilizing equipment

Buying

Published

Language in which you want to receive the document.

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

93/42/EEC

Medical devices

Harmonized/Supporting
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WITHDRAWN
EN ISO 15883-2:2006

NOW

PUBLISHED
EN ISO 15883-2:2009
60.60 Standard published
Jun 3, 2009

REVISED BY

IN_DEVELOPMENT
prEN ISO 15883-2

Relations

Adopted from ISO 15883-2:2006 IDENTICAL