BS EN ISO 15883-4:2018 Washer-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

BS EN ISO 15883-4:2018

Washer-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

Status : Current   Published : December 2018

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.

This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria.

The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified.

WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).

The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.




Standard NumberBS EN ISO 15883-4:2018
TitleWasher-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
StatusCurrent
Publication Date19 December 2018
Normative References(Required to achieve compliance to this standard)ISO 15883-1:2006/AMD 1:2014, ISO 15883-1:2006, ISO/TS 15883-5:2005, EN 12353, IEC 61010-2-040, ISO 14971, EN 13727
Informative References(Provided for Information)ISO 11737-1, EN 14561, EN 14562, EN 14348, EN 14563, ISO 11138-1, EN 14476, ISO 384, EN 14885, EN 1822, ASTM E2314?03, EN 13624, EN 14347, ASTM E2111 - 05, ASTM E1052 - 11, ASTM E2197 - 11, ASTM E1053 - 11
ReplacesBS EN ISO 15883-4:2009
International RelationshipsEN ISO 15883-4:2018,ISO 15883-4:2018
Draft Superseded By16/30288024 DC
DescriptorsSterilizers, Performance testing, Conformity, Performance, Cleaning, Medical equipment, Cleaning equipment, Disinfectant tests, Washing, Sterilization (hygiene), Endoscopic apparatus, Hospital equipment
ICS11.080.10
Title in FrenchLaveurs désinfecteurs Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des endoscopes thermolabiles
Title in GermanReinigungs-Desinfektionsgeräte Anforderungen und Prüfverfahren für Reinigungs- Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope
CommitteeCH/198
ISBN978 0 580 83938 2
PublisherBSI
FormatA4
DeliveryYes
Pages94
File Size2.968 MB
Price£274.00


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