EN ISO 14698-1:2003
(Main)Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.
Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle - Teil 1: Allgemeine Grundlagen (ISO 14698-1:2003)
Dieser Teil von ISO 14698 legt die Grundlagen und grundlegende Verfahrensweisen für ein formelles System zur Biokontaminationskontrolle (Betriebliches System) in solchen Bereichen fest, in denen Reinraum-technologie zu diesem Zweck angewendet wird. Dieser Teil von ISO 14698 legt die Verfahren fest, die notwendig sind, um Risikobereiche konsistent zu überwachen und nach dem Grad der Gefährdung geeignete Kontrollmaßnahmen anwenden zu können. Für Bereiche mit nur geringem Risiko kann dieser Teil von ISO 14698 als Informationsquelle verwendet werden.
Es werden keine anwendungsspezifischen Anforderungen festgelegt. Auch werden Fragen des Brandschutzes und der Sicherheit nicht angesprochen. Im Hinblick auf diese Fragen siehe Sicherheits- und Brandschutzvorschriften.
Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination - Partie 1: Principes généraux et méthodes (ISO 14698-1:2003)
L'ISO 14698-1:2003 établit les principes et la méthodologie fondamentale d'un Système formalisé de maîtrise de la biocontamination (Système formalisé), système destiné à évaluer et à maîtriser la biocontamination, dans le cadre de l'application des technologies des salles propres à cet effet. L'ISO 14698-1:2003 spécifie les méthodes requises pour assurer une surveillance cohérente des zones à risque et pour appliquer les mesures de maîtrise adaptées au degré de risque concerné. Dans des zones où le risque est faible, l'ISO 14698-1:2003 peut servir de source d'informations.
L'ISO 14698-1:2003 ne fixe pas d'exigences spécifiques à des applications, ni ne traite des questions d'incendie et de sécurité pour lesquelles il convient de consulter les exigences réglementaires et autres documentations nationales ou locales.
Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2004
Cleanrooms and associated controlled environments - Biocontamination control -
Part 1: General principles and methods (ISO 14698-1:2003)
Cleanrooms and associated controlled environments - Biocontamination control - Part 1:
General principles and methods (ISO 14698-1:2003)
Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle - Teil 1:
Allgemeine Grundlagen (ISO 14698-1:2003)
Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination
- Partie 1: Principes généraux et méthodes (ISO 14698-1:2003)
Ta slovenski standard je istoveten z: EN ISO 14698-1:2003
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 14698-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2003
ICS 13.040.35
English version
Cleanrooms and associated controlled environments -
Biocontamination control - Part 1: General principles and
methods (ISO 14698-1:2003)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche -
Maîtrise de la biocontamination - Partie 1: Principes Biokontaminationskontrolle - Teil 1: Allgemeine Grundlagen
généraux et méthodes (ISO 14698-1:2003) (ISO 14698-1:2003)
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 14698-1:2003 E
worldwide for CEN national Members.
CORRECTED 2003-10-01
Foreword
This document (EN ISO 14698-1:2003) 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 14698-1:2003 has been approved by CEN as EN ISO 14698-1:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
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
Cleanrooms and associated
ISO 14644-4 2001 EN ISO 14644-4 2001
controlled environments — Part 4:
Design, construction and start-up
Cleanrooms and associated
ISO 14698-2 2003 EN ISO 14698-2 2003
controlled environments -
Biocontamination control - Part 2:
Evaluation and interpretation of
biocontamination data
INTERNATIONAL ISO
STANDARD 14698-1
First edition
2003-09-01
Cleanrooms and associated controlled
environments — Biocontamination
control —
Part 1:
General principles and methods
Salles propres et environnements maîtrisés apparentés — Maîtrise de
la biocontamination —
Partie 1: Principes généraux et méthodes
Reference number
ISO 14698-1:2003(E)
©
ISO 2003
ISO 14698-1:2003(E)
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ii © ISO 2003 — All rights reserved
ISO 14698-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Principles of biocontamination control . 4
5 Establishing the Formal System . 5
6 Expression, interpretation and reporting of results. 10
7 Verification of the Formal System. 11
8 Training . 11
9 Documentation . 11
Annex A (informative) Guidance on determining airborne biocontamination . 12
Annex B (informative) Guidance on validating air samplers . 15
Annex C (informative) Guidance on determining biocontamination of surfaces . 18
Annex D (informative) Guidance on determining biocontamination of textiles. 20
Annex E (informative) Guidance on validating laundering processes. 22
Annex F (informative) Guidance on determining biocontamination of liquids . 26
Annex G (informative) Guidance on training . 28
Bibliography . 31
ISO 14698-1:2003(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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14698-1 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
iv © ISO 2003 — All rights reserved
ISO 14698-1:2003(E)
Introduction
The principles described here are intended to promote appropriate hygienic practices. This part of ISO 14698 is
one of a number of standards considering factors important for the creation of clean, controlled environments.
Hygiene has become increasingly important in many areas of modern society. In such areas, hygiene or
biocontamination control methods are, or will be, used to create safe and stable products. International trade
in hygiene-sensitive products has greatly increased. At the same time, the use of antimicrobial agents has
been reduced or forbidden, creating a need for increased biocontamination control.
This part of ISO 14698 is the first general International Standard for biocontamination control. However, many
factors besides cleanliness must be considered in the design, specification, operation and control of
cleanrooms and associated controlled environments.
In some circumstances, relevant regulatory agencies could impose supplementary policies or restrictions. In
such situations, appropriate adaptations of the standard testing procedures might be required.
INTERNATIONAL STANDARD ISO 14698-1:2003(E)
Cleanrooms and associated controlled environments —
Biocontamination control —
Part 1:
General principles and methods
1 Scope
This part of ISO 14698 establishes the principles and basic methodology of a formal system of
biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom
technology is applied for that purpose. This part of ISO 14698 specifies the methods required for monitoring
risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In
zones where risk is low, it can be used as a source of information.
Application-specific requirements are not given. Neither are fire and safety issues addressed; for these, see
regulatory requirements and other national or local documentation.
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 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control —
Part 2: Evaluation and interpretation of biocontamination data
3 Terms and definitions
For the purposes of this document, th
...
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