SIST EN ISO 7218:2007/A1:2013
(Amendment)Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiological examinations - Amendment 1 (ISO 7218:2007/Amd 1:2013)
Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiological examinations - Amendment 1 (ISO 7218:2007/Amd 1:2013)
This International Standard gives general requirements and guidance/options intended for three main uses: - implementation of ISO/TC 34/SC 9 or ISO/TC 34/SC 5 standards for detection or enumeration of microorganisms, named hereafter "specific standards"; - good laboratory practice for food microbiological laboratories (the purpose is not to detail them in this International Standard, manuals are available for that purpose); - guidance for accreditation of food microbiological laboratories (this International Standard describes the technical requirements according to Annex B of ISO/IEC 17025:2005 for the accreditation of a microbiological laboratory by national organizations). The requirements of this International Standard supersede the corresponding ones of existing specific standards.
Mikrobiologie von Lebensmitteln und Futtermitteln - Allgemeine Anforderungen und Leitlinien für mikrobiologische Untersuchungen - Änderung 1 (ISO 7218:2007/Amd 1:2013)
N/A
Microbiologie des aliments - Exigences générales et recommandations - Amendement 1 (ISO 7218:2007/Amd 1:2013)
Mikrobiologija živil in krme - Splošne zahteve in navodila za mikrobiološke preiskave - Dopolnilo A1 (ISO 7218:2007/Amd 1:2013)
Ta mednarodni standard opredeljuje splošne zahteve in navodila/možnosti za tri glavne načine uporabe: – izvajanje standardov ISO/TC 34/SC 9 ali ISO/TC 34/SC 5 za odkrivanje in štetje mikroorganizmov, v nadaljnjem besedilu »posebni standardi«, – dobra laboratorijska praksa za mikrobiološke laboratorije za preiskave živil (teh ta mednarodni standard ne opredeljuje, za to so na voljo priročniki); –navodila za akreditacijo mikrobioloških laboratorijev za preiskave živil (ta mednarodni standard opisuje tehnične zahteve iz Dodatka B standarda ISO/IEC 17025:2005 za akreditacijo mikrobiološkega laboratorija s strani državnih organizacij). Zahteve tega mednarodnega standarda nadomeščajo ustrezne zahteve obstoječih posebnih standardov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2013
Mikrobiologija živil in krme - Splošne zahteve in navodila za mikrobiološke
preiskave - Dopolnilo A1 (ISO 7218:2007/Amd 1:2013)
Microbiology of food and animal feeding stuffs - General requirements and guidance for
microbiological examinations - Amendment 1 (ISO 7218:2007/Amd 1:2013)
Mikrobiologie von Lebensmitteln und Futtermitteln - Allgemeine Anforderungen und
Leitlinien für mikrobiologische Untersuchungen - Änderung 1 (ISO 7218:2007/Amd
1:2013)
Microbiologie des aliments - Exigences générales et recommandations - Amendement 1
(ISO 7218:2007/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 7218:2007/A1:2013
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 7218:2007/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2013
ICS 07.100.30
English Version
Microbiology of food and animal feeding stuffs - General
requirements and guidance for microbiological examinations -
Amendment 1 (ISO 7218:2007/Amd 1:2013)
Microbiologie des aliments - Exigences générales et Mikrobiologie von Lebensmitteln und Futtermitteln -
recommandations - Amendement 1 (ISO 7218:2007/Amd Allgemeine Anforderungen und Leitlinien für
1:2013) mikrobiologische Untersuchungen - Änderung 1 (ISO
7218:2007/Amd 1:2013)
This amendment A1 modifies the European Standard EN ISO 7218:2007; it was approved by CEN on 15 June 2013.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7218:2007/A1:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 7218:2007/A1:2013) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by February 2014, and conflicting national standards shall be withdrawn
at the latest by February 2014
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7218:2007/Amd 1:2013 has been approved by CEN as EN ISO 7218:2007/A1:2013 without
any modification.
INTERNATIONAL ISO
STANDARD 7218
Third edition
2007-08-15
AMENDMENT 1
2013-08-01
Microbiology of food and animal feeding
stuffs — General requirements and
guidance for microbiological
examinations
AMENDMENT 1
Microbiologie des aliments — Exigences générales et
recommandations
AMENDEMENT 1
Reference number
ISO 7218:2007/Amd.1:2013(E)
©
ISO 2013
ISO 7218:2007/Amd.1:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2013 – All rights reserved
ISO 7218:2007/Amd.1:2013(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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of
ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2, www.iso.org/directives.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received, www.iso.org/patents.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
The committee responsible for this document is ISO//TC 34, Food products, Subcommittee SC 9,
Microbiology.
ISO 7218:2007/Amd.1:2013(E)
Microbiology of food and animal feeding stuffs — General
requirements and guidance for microbiological examinations
AMENDMENT 1
Page 1, Clause 2
Delete ISO 8261. This has been superseded by ISO 6887-5 [already included in "ISO 6887 (all parts)"].
Delete the entries numbered "ISO 835 (all parts)", "ISO 8655-1", "ISO/TS 11133 (all parts)", and "ISO 16140"
and insert the following.
ISO 835, Laboratory glassware — Graduated pipettes
ISO 8655 (all parts), Piston-operated volumetric apparatus
ISO 11133, Microbiology of food, animal feed and water — Preparation, production, storage and
performance testing of culture media
ISO 16140-2, Microbiology of food and animal feed — Method validation — Part 2: Protocol for the
validation of alternative (proprietary) methods against a reference method
Pages 6 to 30, Clauses 5 and 6
Delete the existing text and insert the following.
5 Apparatus and equipment
5.1 General
In accordance with good laboratory practice, all apparatus and equipment should be kept clean and in good working
condition. Before use, equipment should be verified as fit for the intended purpose and its performance monitored during
use, where appropriate.
Where necessary, equipment and monitoring devices should be calibrated to traceable national standards, and
recalibration and any necessary intermediate checks performed, and procedures and results documented.
Equipment should be regularly checked and maintained to ensure safety and fitness for use. Equipment should be
monitored according to the working conditions and the accuracy demanded for the results.
The frequency of calibration and verification checks of each item of equipment is, in most cases, not specified
in this International Standard, since it shall be determined by each laboratory, depending on the type of
equipment and on the laboratory’s level of activity, and in accordance with the manufacturer’s instructions. In
a limited number of cases, a frequency has been specified since it was considered to be essential.
ISO 7218:2007/Amd.1:2013(E)
Apparatus and equipment shall be constructed and installed to facilitate operation and to allow for ease of
maintenance, cleaning, decontamination and calibration.
Any measurement uncertainties given in this clause relate to the apparatus and equipment concerned and not
to the whole method of analysis.
Throughout this clause, requirements for accuracy of measuring equipment are given. These are based on the
practical tolerance required to demonstrate suitable control of equipment in routine use. The accuracy stated
is related to the metrological uncertainty of the device (see ISO/IEC Guide 99).
For temperature control equipment, check the stability and homogeneity of the temperature before initial use
and after any repair or modification which might have an effect on the temperature control.
5.2 Protective cabinets
5.2.1 Description
A protective cabinet is a work station with horizontal or vertical laminar airflow to remove dust and other
particles, such as microbes, from the air.
The maximum tolerable number of particles per cubic metre with a size greater than or equal to 0,5 µm
represents the dust-spreading class of a safety cabinet. For cabinets used in food microbiology, the number of
particles shall not exceed 4 000 per cubic metre.
Cabinets for use in food microbiology laboratories are of four types.
a) Class I biosafety cabinets are open-fronted exhaust-protective cabinets that are intended to protect the
operator and the environment but will not protect the product from extraneous contamination. Potentially
infected aerosols will be contained within the cabinet and trapped by impaction on the filter. The filtered
air is normally discharged to the atmosphere; if this is not done, the air shall pass through two high-
efficiency particulate air (HEPA) filters mounted in series. They are not recommended for work with risk
category 3 pathogens because of the difficulties in maintaining and ensuring appropriate operator
protection.
b) Class II biosafety cabinets protect the product, the operator and the environment. They recirculate some
filtered air, exhaust some to the atmosphere and take in replacement air through the working aperture,
thereby providing operator protection. They are suitable for work with risk category 2 and 3 pathogens.
c) Horizontal laminar outflow cabinets protect the work from contamination, but blow any aerosols generated
into the operator’s face. Therefore they are not suitable for handling inoculated cultures or preparation of
tissue culture.
d) Vertical laminar airflow cabinets protect the product by the use of vertical laminar flow of HEPA-filtered air.
They also protect the operator by the use of internally recirculated air. They are particularly suitable for
providing an aseptic environment for handling sterile products and for protecting the operator when
handling powders.
Use protective cabinets for all work involving the handling of pathogens and contaminated powders, if required
by national regulations.
The use of a gas burner or wire incinerator is not recommended in protective cabinets. If it is necessary, the gas burner
should have a small flame so that the airflow is not disturbed. The use of disposable equipment (loops, pipettes, etc.) is a
suitable alternative.
5.2.2 Use
Use protective cabinets that are appropriate for the intended application and environmental conditions in the
laboratory.
2 © ISO 2013 – All rights reserved
ISO 7218:2007/Amd.1:2013(E)
Cabinets should be kept as free of equipment as possible.
Where practicable, place everything needed inside the cabinet before starting work to minimize the number of
arm movements into and out of the working aperture. Position equipment and materials so as to minimize
disturbance to the airflow at the working aperture.
Operators should be adequately trained in the correct use of cabinets to ensure their safety and the integrity of the product
or culture.
5.2.3 Cleaning and disinfection
Clean and disinfect the working area after use with appropriate and non-corrosive disinfectant in accordance
with the manufacturer’s instructions. Regularly examine wire grids protecting prefilters, if they exist, and wipe
clean with a disinfectant-soaked cloth.
For laminar flow cabinets, the filter face should be vacuum cleaned regularly, taking care not to damage the filter
medium.
Safety cabinets should be fumigated before filter changing
...
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