EN ISO 14160:1998

Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)

Sterilisation von Medizinprodukten für den einmaligen Gebrauch mit Bestandteilen tierischer Herkunft - Validierung und Routineüberwachung der Sterilisation mit flüssigen chemischen Sterilisiermitteln (ISO 14160:1998)

Diese Internationale Norm legt Anforderungen an die Entwicklung, die Validierung sowie die Verfahrensregelung und -überwachung der chemischen Flüssigkeits-Sterilisation von Medizinprodukten für den einmaligen Gebrauch, die ganz oder teilweise aus Materialien tierischen Ursprungs bestehen, fest. Diese Internationale Norm gilt nicht für Materialien menschlicher Herkunft. Diese Internationale Norm beschreibt kein Qualitätssicherungssystem zur Überwachung aller Stufen des Herstellungsverfahrens.

Stérilisation des dispositifs médicaux non réutilisables contenant des matières d'origine animale - Validation et contrôle de routine de la stérilisation par agents stérilisants chimiques liquides (ISO 14160:1998)

Sterilizacija medicinskih pripomočkov za enkratno uporabo, ki vsebujejo materiale živalskega izvora - Validacija in redni nadzor sterilizacije s tekočimi kemijskimi sredstvi za sterilizacijo (ISO 14160:1998)

General Information

• Status: Withdrawn
• Publication Date: 17-Mar-1998
• Withdrawal Date: 30-Jun-2011
• ICS: 11.080 - Sterilization and disinfection
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 7 - Liquid chemical treatment of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Jul-2011
• Completion Date: 01-Jul-2011
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14160:2000 - Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)

Relations

• Replaced By: EN ISO 14160:2011 - Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
• Effective Date: 11-Jul-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14160:2000
01-januar-2000
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY]DHQNUDWQRXSRUDERNLYVHEXMHMRPDWHULDOH
åLYDOVNHJDL]YRUD9DOLGDFLMDLQUHGQLQDG]RUVWHULOL]DFLMHVWHNRþLPLNHPLMVNLPL
VUHGVWYL]DVWHULOL]DFLMR,62
Sterilization of single-use medical devices incorporating materials of animal origin -
Validation and routine control of sterilization by liquid chemical sterilants (ISO
14160:1998)
Sterilisation von Medizinprodukten für den einmaligen Gebrauch mit Bestandteilen
tierischer Herkunft - Validierung und Routineüberwachung der Sterilisation mit flüssigen
chemischen Sterilisiermitteln (ISO 14160:1998)
Stérilisation des dispositifs médicaux non réutilisables contenant des matieres d'origine
animale - Validation et contrôle de routine de la stérilisation par agents stérilisants
chimiques liquides (ISO 14160:1998)
Ta slovenski standard je istoveten z: EN ISO 14160:1998
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 14160:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 14160
First edition
1998-03-15
Sterilization of single-use medical devices
incorporating materials of animal origin —
Validation and routine control of
sterilization by liquid sterilants
Stérilisation des dispositifs médicaux non réutilisables contenant des
matières d’origine animale — Validation et contrôle de routine de la
stérilisation par agents stérilisants chimiques liquides
A
Reference number
ISO 14160:1998(E)

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ISO 14160:1998(E)
Contents Page
1 Scope . 1
1
2 Normative references .
2
3 Definitions .
4 General. 4
5 Validation . 5
6 Process control and monitoring . 7
7 Product release from sterilization . 9
Annexes
A Guidance . 10
B References to European Standards with their relevant equi-
valents . 19
C Bibliography . 21
©  ISO 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet [e-mail]
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii

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©
ISO
ISO 14160:1998(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide
federation of national standards bodies (ISO member bodies). The work of
preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on
that committee. International organizations, governmental and non-
governmental, in liaison with ISO, also take part in the work. ISO collaborates
closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75% of the member bodies casting a
vote.
International Standard ISO 14160 was prepared by Technical Committee
ISO/TC 198, Sterilization of health care products.
Annexes A, B and C of this International Standard are for information only.
iii

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©
ISO 14160:1998(E) ISO
Introduction
A sterile product item is one which is free of viable microorganisms.
International Standards require, when it is necessary to supply a sterile
product item, that adventitious microbiological contamination of a medical
device from all sources prior to sterilization be minimized by all practical
means. Even so, product items produced under defined manufacturing
conditions in accordance with the requirements for quality systems for
medical devices (see ISO 13485 and ISO 13488) can, prior to sterilizati
...