EN ISO 14160:1998
(Main)Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (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)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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)
ISO 14160:1998(E)
Contents Page
1 Scope . 1
2 Normative references .
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
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Internet central@iso.ch
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Printed in Switzerland
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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.
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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 sterilization,
have microorganisms on them, albeit in low numbers. Such product items are
non-sterile. The purpose of sterilization processing is to inactivate the
microbiological contaminants and thereby transform the non-sterile items into
sterile ones.
The inactivation of a pure culture of microorganisms by physical and/or
chemical agents used to sterilize medical devices often approximates an
exponential relationship; inevitably this means that there is always a finite
probability that a microorganism can survive regardless of the extent of
treatment applied. For a given treatment, the probability of survival is
determined by the number and types of microorganisms and by the
environment in which the organisms exist during treatment. It follows that the
sterility of any one item in a population of items subjected to sterilization
processing cannot be guaranteed and the sterility of the processed
population of items has to be defined in terms of the probability of there being
a viable microorganism present on the device.
Generic requirements for the quality system for the design/development,
production, installation and servicing are given in the ISO 9000 family of
standards and in ISO 13485 and ISO 13488. The ISO 9000 series of
standards designates certain processes used in manufacture as "special" if
the results cannot be fully verified by subsequent inspection and testing of
the product. Sterilization is an example of a special process because process
efficacy cannot be verified by inspection and testing of the product. For this
reason, sterilization processes have to be validated before use, the
performance of the process monitored routinely and the equipment
maintained.
It is important to be aware that the exposure to a properly validated and
accurately controlled sterilization process is not the only factor associated
with the provision of reliable assurance that the product is sterile and in this
respect suitable for its intended use. Attention has also to be given to a
number of factors, including the microbiological status (bioburden) of
incoming raw materials and/or components, their subsequent storage, and to
the control of the environment in which the product is manufactured,
assembled and packaged.
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ISO 14160:1998(E)
The agents for sterilization used most frequently for medical devices are
moist heat, dry heat, irradiation and ethylene oxide. While some devices
containing animal tissues may be compatible with these commonly applied
methods of sterilization (for example catgut sutures are usually sterilized by
irradiation), other devices, such as biological heart valves or tissue patches,
are not compatible with conventional sterilization processes. It has been
recognized that other sterilizing agents might have to be used in these
exceptional circumstances. Liquid chemical sterilants have been widely used
in such instances and, in common with the other sterilization methods, the
efficacy of the process needs to be demonstrated and recorded before it is
adopted for routine use.
This International Standard contains requirements for the validation and
routine monitoring of sterilization of single-use medical devices containing
materials of animal origin by exposure to liquid chemical sterilants; guidance
on the application of this International Standard is given in annex A.
Manufacturing processes for medical devices containing animal tissues
frequently include exposure to chemical agents which can in themselves
reduce significantly the bioburden on the medical device. Following the
manufacturing process, a medical device is exposed to a defined sterilization
process; the requirements for validation and routine control described in this
International Standard apply only to this defined sterilization process and do
not take account of the lethal effects of other bioburden reduction steps.
NOTE — The guidance given in annex A is not obligatory and it is not provided as a
check list for auditors.
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INTERNATIONAL STANDARD ISO ISO 14160:1998(E)
Sterilization of single-use medical devices incorporating materials
of animal origin — Validation and routine control of sterilization by
liquid chemical sterilants
1 Scope
This International Standard specifies requirements for the development, validation, process control and monitoring of
the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part,
materials of animal origin.
This International Standard does not apply to material of human origin.
This International Standard does not describe a quality assurance system for the control of all stages of manufacture.
NOTE 1 Attention is drawn to the standards for quality systems (see ISO 9001 and ISO 13485 or ISO 9002 and ISO 13488) which
can be used in the control of all stages of manufacture including the sterilization process.
This International Standard does not describe tests to establish the effects of any chosen sterilization method upon the
fitness for use of the medical device.
NOTE 2 Such testing is a crucial part of the design and development of a medical device.
This International Standard does not describe methods for the validation of the inactivation of viruses.
NOTE 3 In developing a method for processing medical devices containing materials of animal origin, consideration of the effects
of liquid chemical sterilization on potential viral contaminants will also be necessary because of the source of materials used in the
manufacture of these particular medical devices. The importance of validation of viral inactivation for processes within the scope of
this International Standard is recognized. This aspect is excluded from this International Standard; a separate European Standard
is in preparation (EN 12442-3).
NOTE 4 Liquid chemical sterilants traditionally employed to sterilize animal tissues in medical devices may not be effective in
inactivating the causative agents of transmissable spongiform encephalopathies such as bovine spongiform encephalopathy
(BSE), or scrapie. Satisfactory validation in accordance with this International Standard should not be assumed to demonstrate
inactivation of infective agents of this type.
This International Standard does not cover the level of residual sterilant within medical devices.
NOTE 5 ISO 14538 is concerned with this issue.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision,
agreements based on this International Standard are encouraged to investigate the possibility of applying the most
recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid
International Standards.
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ISO 14160:1998(E)
ISO 9001:1994, Quality systems — Model for quality assurance in design, development, production, installation and
servicing.
ISO 9002:1994, Quality systems — Model for quality assurance in production, installation and servicing.
ISO 11138-1:1994, Sterilization of health care products— Biological indicators — Part 1: General.
ISO 11737-1:1995, Sterilization of health care products — Microbiological methods — Part 1: Estimation of the
population of microorganisms on product.
NOTE — The relationship between International Standards and European Standards is given in annex B.
3 Definitions
For the purposes of this International Standard, the following definitions apply.
3.1
batch
defined quantity of bulk, intermediate, or finished product that is intended or purported to be uniform in character
and quality, and which has been produced during a defined cycle of manufacture
3.2
bioburden
population of viable microorganisms on a product and/or a package
3.3
carrier
supporting material on which test organisms are deposited
3.4
commissioning
obtaining and documenting evidence that equipment has been provided and installed in accordance with its
specifications and that it functions within predetermined limits when operated in accordance with operational
instructions
3.5
decimal reduction value
D-value
time (expressed in minutes) or irradiation dose (expressed in kilograys) required to achieve inactivation of 90 % of a
population of the test organism under stated exposure conditions
3.6
exposure time
time for which the medical device is exposed at the specified temperature and sterilant concentration
3.7
inactivation
process resulting in the loss of the ability of microorganisms to grow and/or multiply
NOTE — For the purpose of this International Standard, microorganisms comprise sporing and non-sporing bacteria, viruses, fungi
and protozoa.
3.8
inoculated carrier
carrier on which a defined number of test organisms has been deposited
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3.9
liquid chemical sterilant
defined formulation of chemicals in a solution or liquid form which is applied to achieve sterility
3.10
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the
software necessary for its proper application, intended by the manufacturer to be used for human beings for the
purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap;
— investigation, replacement or modification of the anatomy or of a physiological process;
— control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or
metabolic means, but which may b
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