NF EN ISO 15883-5

NF EN ISO 15883-5

August 2021
Standard Current

Washer-disinfectors - Part 5 : performance requirements and test method criteria for demonstrating cleaning efficacy

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.NOTE 1   The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.NOTE 2   This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2021

Number of pages

75 p.

Reference

NF EN ISO 15883-5

ICS Codes

11.080.10   Sterilizing equipment

Classification index

S98-040-5

Print number

1

International kinship

ISO 15883-5:2021

European kinship

EN ISO 15883-5:2021
Sumary
Washer-disinfectors - Part 5 : performance requirements and test method criteria for demonstrating cleaning efficacy

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.

NOTE 1   The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.

NOTE 2   This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.

Replaced standards (1)
XP CEN ISO/TS 15883-5
November 2006
Standard Cancelled
Washer-disinfectors - Part 5 : test soils and methods for demonstrating cleaning efficacy

ISO/TS 15883-5:2005 includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards. The inclusion of the test soils and methods in ISO/TS 15883-5:2005 does not indicate that they are of equivalent sensitivity in their determination of cleaning efficacy. Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for each method. Where chemical detection of residual soiling is required/sought, methods can be complemented by the specific determination of a residual component of the applied test soil. NOTE 1 The test soils and methods included in ISO/TS 15883-5:2005 are sourced from national standards and published documents submitted by member bodies of the Technical Committee preparing ISO/TS 15883-5:2005. They have been edited only to provide a uniform format within ISO/TS 15883-5:2005. NOTE 2 An example of this is the use of the peroxidase test to detect residual blood (haemoglobin) from the test soil applied to surgical instruments or flexible endoscopes (e.g. using the method described in ISO/TS 15883-5:2005). See also ISO 15883-1:2005, Annex D.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences de performance
  • 5 Essais de conformité
  • Annexe B (normative) Évaluation des performances des souillures d'essai protéiniques
  • Annexe A (informative) Exemples de souillures d'essai
  • Annexe C (informative) Méthodes d'essai pour la détection et l'évaluation de souillure protéinique résiduelle
  • Annexe D (informative) Exemples de méthodes d'essai de détection de l'hémoglobine pour l'évaluation de l'efficacité du nettoyage
  • Annexe E (informative) Évaluation des performances des souillures d'essai - Feuilles de résultats des échantillons
  • Bibliographie
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