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Withdrawn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
14-Sep-2003
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
12-Aug-2020

RELATIONS

Buy Standard

Standard
EN ISO 14698-2:2004
English language
14 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

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.

---------------------- Page: 1 ----------------------
SIST EN ISO 14698-2:2004
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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).

---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
SIST EN ISO 14698-2:2004
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
SIST EN ISO 14698-2:2004
ISO 14698-2:2003(E)
PDF disclaimer

This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not

be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this

file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this

area.
Adobe is a trademark of Adobe Systems Incorporated.

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters

were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event

that a problem relating to it is found, please inform the Central Secretariat at the address given below.

© ISO 2003

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 either ISO at the address below or ISO's member body

in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.ch
Web www.iso.ch
Printed in Switzerland
ii © ISO 2003 — All rights reserved
---------------------- Page: 8 ----------------------
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
---------------------- Page: 9 ----------------------
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
---------------------- Page: 10 ----------------------
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
---------------------- Page: 11 ----------------------
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
---------------------- Page: 12 ----------------------
SIST EN ISO 14698-2:2004
ISO 14698-2:2003(E)
3.16
viable unit
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
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.