SIST EN ISO 14698-2:2004

Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003)

ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1.

Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle - Teil 2: Auswertung und Interpretation von Biokontaminationsdaten (ISO 14698-2:2003)

Dieser Teil von ISO 14698 gibt Hinweise hinsichtlich Verfahren zur Auswertung mikrobiologischer Daten und zur Abschätzung der Ergebnisse der Sammlung lebensfähiger Partikel in Risikobereichen der Biokontamination. Soweit möglich, sollte er in Verbindung mit ISO 14698-1 genutzt werden.

Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination - Partie 2: Evaluation et interprétation des données de biocontamination (ISO 14698-2:2003)

L'ISO 14698-2:2003 présente des conseils concernant les méthodes d'évaluation des données microbiologiques et d'estimation des résultats obtenus par l'échantillonnage de particules viables dans des zones à risque. Il convient de l'utiliser, selon le cas, conjointement avec l'ISO 14698-1.

Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003)

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-2003
• Withdrawal Date: 31-Aug-2020
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: SS SPL - Technical Board for the general field
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 26-Aug-2020
• Due Date: 18-Sep-2020
• Completion Date: 01-Sep-2020
• Ref Project: EN ISO 14698-2:2003 - Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003)

Relations

• Corrected By: SIST EN ISO 14698-2:2004/AC:2007 - Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003/Cor.1:2004)
• Effective Date: 22-Dec-2008
• Corrected By: SIST EN ISO 14698-2:2004/AC:2007 - Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003/Cor.1:2004)
• Effective Date: 08-Jun-2022
• Replaced By: SIST EN 17141:2020 - Cleanrooms and associated controlled environments - Biocontamination control
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14698-2:2004
01-januar-2004
Cleanrooms and associated controlled environments - Biocontamination control -
Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003)
Cleanrooms and associated controlled environments - Biocontamination control - Part 2:
Evaluation and interpretation of biocontamination data (ISO 14698-2:2003)
Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle - Teil 2:
Auswertung und Interpretation von Biokontaminationsdaten (ISO 14698-2:2003)
Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination
- Partie 2: Evaluation et interprétation des données de biocontamination (ISO 14698-
2:2003)
Ta slovenski standard je istoveten z: EN ISO 14698-2:2003
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14698-2:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14698-2:2004

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SIST EN ISO 14698-2:2004
EUROPEAN STANDARD
EN ISO 14698-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2003
ICS 13.040.35
English version
Cleanrooms and associated controlled environments -
Biocontamination control - Part 2: Evaluation and interpretation
of biocontamination data (ISO 14698-2:2003)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche -
Maîtrise de la biocontamination - Partie 2: Evaluation et Biokontaminationskontrolle - Teil 2: Auswertung und
interprétation des données de biocontamination (ISO Interpretation von Biokontaminationsdaten (ISO 14698-
14698-2:2003) 2:2003)
This European Standard was approved by CEN on 10 July 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14698-2:2003 E
worldwide for CEN national Members.

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SIST EN ISO 14698-2:2004
EN ISO 14698-2:2003 (E)
CORRECTED 2003-11-05
Foreword
This document (EN ISO 14698-2:2003) has been prepared by Technical Committee ISO/TC 209
"Cleanrooms and associated controlled environments" in collaboration with Technical Committee
CEN/TC 243 "Cleanroom technology", the secretariat of which is held by BSI.
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 March 2004, and conflicting national
standards shall be withdrawn at the latest by March 2004.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 14698-2:2003 has been approved by CEN as EN ISO 14698-2:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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SIST EN ISO 14698-2:2004
EN ISO 14698-2:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 14698-1 2003 Cleanrooms and associated EN ISO 14698-1 2003
controlled environments -
Biocontamination control - Part 1:
General principles and methods
3

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SIST EN ISO 14698-2:2004

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SIST EN ISO 14698-2:2004


INTERNATIONAL ISO
STANDARD 14698-2
First edition
2003-09-15


Cleanrooms and associated controlled
environments — Biocontamination
control —
Part 2:
Evaluation and interpretation of
biocontamination data
Salles propres et environnements maîtrisés apparentés — Maîtrise de la
biocontamination —
Partie 2: Évaluation et interprétation des données de biocontamination




Reference number
ISO 14698-2:2003(E)
©
 ISO 2003

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SIST EN ISO 14698-2:2004
ISO 14698-2:2003(E)
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ii © ISO 2003 — All rights reserved

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SIST EN ISO 14698-2:2004
ISO 14698-2:2003(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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.
Attention is drawn to the possibility that some of the elements of this part of ISO 14698 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 14698-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and
associated controlled environments.
ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled
environments — Biocontamination control:
 Part 1: General principles and methods
 Part 2: Evaluation and interpretation of biocontamination data

© ISO 2003 — All rights reserved iii

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SIST EN ISO 14698-2:2004
ISO 14698-2:2003(E)
Introduction
This part of ISO 14698 presents a framework for the evaluation of biocontamination data collected following the
principles and methods given in ISO 14698-1. It may also be applied to biocontamination data collected by other
systems.

iv © ISO 2003 — All rights reserved

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SIST EN ISO 14698-2:2004
INTERNATIONAL STANDARD ISO 14698-2:2003(E)

Cleanrooms and associated controlled environments —
Biocontamination control —
Part 2:
Evaluation and interpretation of biocontamination data
1 Scope
This part of ISO 14698 gives guidance on methods for the evaluation of microbiological data and the estimation of
results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used,
where appropriate, in conjunction with ISO 14698-1.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
ISO 14698-1:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 1:
General principles and methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
action level
microbiological level set by the user in the context of controlled environments, which, when exceeded, requires
immediate intervention, including investigation of cause, and corrective action
3.2
alert level
microbiological level set by the user for controlled environments, giving early warning of a potential drift from
normal conditions
NOTE When alert levels are exceeded, this should result in increased attention to the process.
3.3
audit trail
chain of related documents, or entries within records, that allows related information to be traced
3.4
biocontamination
contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles
© ISO 2003 — All rights reserved 1

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SIST EN ISO 14698-2:2004
ISO 14698-2:2003(E)
3.5
cleanroom
room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner
to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant
parameters, e.g. temperature, humidity and pressure, are controlled as necessary
[1]
[ISO 14644-1:1999, 2.1.1]
3.6
data stratification
regrouping of data so that important trends and deviations can be more easily seen and understood
3.7
estimate
value of an estimator obtained as a result of an estimation
[2]
[ISO 3534-1:1993, 2.51]
3.8
estimation
operation of assigning, from the observations in a sample, numerical values to the parameters of a distribution
chosen as the statistical model for the population from which this sample is taken
[2]
[ISO 3534-1:1993, 2.49]
3.9
estimator
statistic used to estimate a population parameter
[2]
[ISO 3534-1:1993, 2.50]
3.10
hazard
biological, chemical or physical element or factor that adversely affects individuals, the environment, process or
product
3.11
risk
combination of the probability of the occurrence of harm and the severity of that harm
[8]
[ISO/IEC Guide 51:1999, 3.2]
3.12
risk zone
defined and delimited space where individuals, products or materials (or any combination of the above) are
particularly vulnerable to biocontamination
3.13
target level
defined microbiological level set by the user, for its own purpose
3.14
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or
application have been fulfilled
[3]
[ISO 9000:2000, 3.8.5]
3.15
viable particle
particle that consists of, or supports, one or more live microorganisms
2 © ISO 2003 — All rights reserved

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SIST EN ISO 14698-2:2004
ISO 14698-2:2003(E)
3.16
viable unit
VU
one or more viable particles that are enumerated as a single unit
NOTE When VU are enumerated as colonies on agar media, it is common usage to name them colony-forming units
(CFU).
4 Evaluation and interpretation of biocontamination data
4.1 General
Information on the setting of action, alert and, where appropriate, target levels, the validation of counting methods
and the collection of biocontamination data are discussed in ISO 14698-1. T
...