NF EN 867-5

NF EN 867-5

November 2001
Standard Cancelled

Non-biological systems for use in sterilizers - Part 5 : specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

Le présent document prescrit les exigences de performances et les méthodes d'essai relatives aux systèmes indicateurs non biologiques, y compris les dispositifs d'épreuves de procédé au sein desquels ils sontdestinés à fonctionner, qui doivent être suivis pour la réalisation d'essais relatifs aux performances de pénétration de la vapeur dans les petits stérilisateurs, appartenant selon les cas au Type B ou au Type S.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2001

Number of pages

29 p.

Reference

NF EN 867-5

ICS Codes

11.080.10   Sterilizing equipment
11.080.20   Disinfectants and antiseptics

Classification index

S98-007

Print number

1 - 23/10/2003

European kinship

EN 867-5:2001
Sumary
Non-biological systems for use in sterilizers - Part 5 : specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

Le présent document prescrit les exigences de performances et les méthodes d'essai relatives aux systèmes indicateurs non biologiques, y compris les dispositifs d'épreuves de procédé au sein desquels ils sontdestinés à fonctionner, qui doivent être suivis pour la réalisation d'essais relatifs aux performances de pénétration de la vapeur dans les petits stérilisateurs, appartenant selon les cas au Type B ou au Type S.
Standard replaced by (1)
NF EN ISO 11140-6
November 2022
Standard Current
Sterilization of health care products - Chemical indicators - Part 6 : type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

<p class="MsoBodyText" style="line-height: 11.5pt; tab-stops: 19.85pt 28.0pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">EN</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">13060</span></span></span>.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE<span style="mso-tab-count: 1;">      </span>The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities.</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">a)<span style="mso-tab-count: 1;">    </span>Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">EN</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">13060</span></span></span>).</span></p> <p class="BodyTextindent1"><span lang="EN-GB">This document specifies the requirements for:</span></p> <p class="MsoListNumber2"><span lang="EN-GB">—<span style="mso-tab-count: 1;">    </span>a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means;</span></p> <p class="MsoListNumber2"><span lang="EN-GB">—<span style="mso-tab-count: 1;">    </span>an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design.</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">b)<span style="mso-tab-count: 1;">    </span>Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">EN</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">13060</span></span></span>).</span></p> <p class="BodyTextindent1"><span lang="EN-GB">This document specifies the requirements for:</span></p> <p class="MsoListNumber2"><span lang="EN-GB">—<span style="mso-tab-count: 1;">    </span>a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;</span></p> <p class="MsoListNumber2"><span lang="EN-GB">—<span style="mso-tab-count: 1;">    </span>an alternative hollow device:</span></p> <p class="MsoListNumber3"><span lang="EN-GB">—<span style="mso-tab-count: 1;">    </span>employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator;</span></p> <p class="MsoListNumber3"><span lang="EN-GB">—<span style="mso-tab-count: 1;">    </span>equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.</span></p>

Table of contents
View the extract
  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    5
  • 3 Termes et définitions
    5
  • 4 Exigences
    6
  • 5 Méthodes d'essai
    11
  • 6 Marquage, étiquetage et emballage
    15
  • Annexe A (normative) Petit appareillage d'exposition à la vapeur d'eau et vapeur d'eau destinés à la réalisation d'essais
    17
  • Annexe B (normative) Cycles d'essais destinés à l'évaluation des performances des indicateurs dans les dispositifs d'épreuve de procédé à charge poreuse
    20
  • Annexe C (normative) Cycles d'essais destinés à l'évaluation des systèmes indicateurs destinés a être employés dans les dispositifs d'épreuve de procédé à charge creuse
    23
  • Annexe D (normative) Cycles d'essais destinés à l'évaluation des dispositifs d'épreuve de procédé à charge creuse
    24
  • Bibliographie
    25
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