NF EN ISO 15883-6

NF EN ISO 15883-6

June 2011
Standard Cancelled

Washer-disinfectors - Part 6 : requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non critical medical devices and healthcare equipment

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

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Main informations

Collections

National standards and national normative documents

Publication date

June 2011

Number of pages

19 p.

Reference

NF EN ISO 15883-6

ICS Codes

11.080.10   Sterilizing equipment

Classification index

S98-040-6

Print number

1 - 10/06/2011

International kinship

ISO 15883-6:2011

European kinship

EN ISO 15883-6:2011
Sumary
Washer-disinfectors - Part 6 : requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non critical medical devices and healthcare equipment

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.

The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

Standard replaced by (1)
NF EN ISO 15883-6
March 2016
Standard Current
Washer-disinfectors - Part 6 : requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences de performance
    2
  • 4.1 Généralités
    2
  • 4.2 Nettoyage
    3
  • 4.3 Désinfection
    3
  • 5 Exigences mécaniques et exigences relatives au contrôle
    4
  • 5.1 Systèmes de contrôle
    4
  • 5.2 Vérification de procédé
    4
  • 6 Essai de conformité
    4
  • 6.1 Généralités
    4
  • 6.2 Essais d'élimination des souillures des parois de la cuve, du support de charge et de la charge
    4
  • 6.3 Essais thermométriques
    5
  • 7 Informations à fournir par le fabricant
    5
  • 8 Informations que le fournisseur du laveur désinfecteur doit demander à l'acheteur
    5
  • Annexe A (informative) Résumé des programmes d'essai
    6
  • Bibliographie
    7
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