20/30422024 DC - BS EN ISO 15883-1. Washer-disinfectors. Part 1. General requirements, terms and definitions and tests

20/30422024 DC

BS EN ISO 15883-1. Washer-disinfectors. Part 1. General requirements, terms and definitions and tests

Status : Current, Draft for public comment   Published : December 2020

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This document specifies general performance requirements for washer-disinfectors and their accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified.

NOTE 1

The requirements can be applied to washer-disinfectors intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

The requirements for washer-disinfectors intended to process specific loads are specified in other parts of the ISO 15883 series. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of the ISO 15883 series apply.

This document does not specify requirements intended for machines for use for laundry or general catering purposes.

This document 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[21].

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

NOTE 2

If it is considered that prion protein can be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein in a manner that can inhibit its removal or inactivation.

This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a washer-disinfector. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed washer-disinfector throughout its service life. Guidance on a routine test programme is given in Annex A.




Standard Number20/30422024 DC
TitleBS EN ISO 15883-1. Washer-disinfectors. Part 1. General requirements, terms and definitions and tests
StatusCurrent, Draft for public comment
Publication Date04 December 2020
Normative References(Required to achieve compliance to this standard)IEC 60751:2008, IEC 61326-1:2012, IEC 60584-1:2013, IEC 61010-2-040:2015, ISO 7000, ISO 10012, IEC 80416-1, ISO 14644-3, IEC 60417-DB, ISO/FDIS 15883-5:2020, ISO 14971
Informative References(Provided for Information)ISO 11737-1, IEC 61508-1, DIN 10510, EN 285, EN 13704, ISO 15883-7, ISO 11138-1, EN 13727, EN 14476, ISO 10993 (all parts), AAMI TIR34, ASTM E2197, ISO 12100, EN 14347, ISO 9000, EN 14348, EN 14561, IEC 62304:2006/A1:2015, ISO 15883-4, EN 13624, EN 17126, ISO 11737-2, ISO 17665-1, EN 1717, ISO 15883-3, ISO 13485, ISO 13849-2, ISO 9001, EN 14885, SIS - TR 3:2002, ASTM E2111, ISO 15883-6, EN 14562, ISO 14698-1, IEC 60073, ISO 15883-2, EN 1822-1:2009, ISO 11139:2018
International RelationshipsISO/DIS 15883-1
Draft Expiry Date27 January 2021
DescriptorsConformity, Veterinary equipment, Sterilization (hygiene), Cleaning, Medical equipment, Laboratory equipment, Safety measures, Hospital equipment, Cleaning equipment, Performance testing, Performance, Washing, Pharmaceutical technology, Dental equipment, Definitions, Disinfectant tests, Electrically-operated devices, Sterilizers
ICS11.080.10
Title in FrenchLaveurs désinfecteurs — Partie 1: Exigences générales, termes et définitions et essais Partie 1: Exigences générales, termes et définitions et essais
CommitteeCH/198
PublisherBSI
FormatA4
DeliveryYes
Pages93
File Size1.263 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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