EN ISO 15883-1:2009

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) EN ISO 15883-1:2009

Publication date:   Aug 21, 2009

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

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Scope

ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.
The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.
ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.
ISO 15883-1:2006 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285.
The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
ISO 15883-1:2006 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.

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 15883-1:2006

NOW

PUBLISHED
EN ISO 15883-1:2009
60.60 Standard published
Jun 3, 2009

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 15883-1:2009/A1:2014

REVISED BY

IN_DEVELOPMENT
FprEN ISO 15883-1

Relations

Adopted from ISO 15883-1:2006 IDENTICAL