NF EN 554

NF EN 554

October 1994
Standard Cancelled mandatory application standard
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Sterilization of medical devices. Validation and routine control of sterilization by moist heat.

Le présent document spécifie les exigences relatives à la mise au point, à la validation, au contrôle et à la surveillance du procédé de stérilisation des dispositifs médicaux à la vapeur d'eau.

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Main informations

Collections

National standards and national normative documents

Publication date

October 1994

Number of pages

25 p.

Reference

NF EN 554

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-105

Print number

1 - 01/10/1994

European kinship

EN 554:1994
Sumary
Sterilization of medical devices. Validation and routine control of sterilization by moist heat.

Le présent document spécifie les exigences relatives à la mise au point, à la validation, au contrôle et à la surveillance du procédé de stérilisation des dispositifs médicaux à la vapeur d'eau.
Standard replaced by (1)
NF EN ISO 17665-1
November 2006
Standard Current
Sterilization of health care products - Moist heat - Part 1 : requirements for the development, validation and routine control of a sterilization process for medical devices

<p><b>I</b>SO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.</p> <p>Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:</p> <ul><li>saturated steam venting systems;</li><li>saturated steam active air removal systems;</li><li>air steam mixtures;</li><li>water spray;</li><li>water immersion.</li></ul>

Table of contents
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  • Avant-propos
    3
  • Introduction
    4
  • 1
    Domaine d'application 5
  • 2
    Références normatives 5
  • 3 Définitions
    6
  • 4 Généralités
    8
  • 5 Validation
    11
  • 6
    Contrôle et surveillance du procédé 13
  • 7
    Libération du produit après stérilisation 14
  • Annexe A (informative) Guide d'application de l'EN 554
    15
  • Annexe B (informative) Bibliographie
    23
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