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ČESKÁ TECHNICKÁ NORMA

ICS 07.100.01;07.080

Leden 1999

Biotechnologie - Vybavení - Návod
pro postupy zkoušení sterilizovatelnosti

ČSN
 EN 12297

83 1006

 

 

 

Biotechnology - Equipment - Guidance on testing procedures for sterilizability

Biotechnologie - Equipment - Guide des procédures d'essai pour le contrôle de la capacité à la stérilisation

Biotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der Sterilisierbarkeit

 

Tato norma přejímá anglickou verzi evropské normy EN 12297:1998. Evropská norma EN 12297:1998 má status české technické normy.

This standard implements the English version of European Standard EN 12297:1998. The European Standard EN 12297:1998 has the status of a Czech Standard.

 

© Český normalizační institut, 1999

Podle zákona č. 22/1997 Sb. smějí být české technické normy rozmnožovány a rozšiřovány jen se souhlasem Českého normalizačního institutu.




53941


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Národní předmluva

 

Vypracování normy

Zpracovatel: RNDr. Ljuba Schlemmerová, CSc., IČO 43060927

Pracovník Českého normalizačního institutu: Ing. Ivana Zittová


Strana 3

EUROPEAN STANDARD

EN 12297

NORME EUROPÉENNE

March 1998

EUROPÄISCHE NORM


 

ICS

 

Descriptors:   biotechnology,  medical   equipment,   sterilization,   disinfection,  contamination,   micro-organisms,  noxious microorganisms, tests, safety, hygiene conditions, inspection, accident prevention, environmental protection, work safety

 

English version

 

Biotechnology - Equipment - Guidance on testing procedures for sterilizability

 

Biotechnologie - Equipment - Guide des procédures d'essai pour le contrôle de la capacité à la stérilisation

Biotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der Sterilisierbarkeit

 

This European Standard was approved by CEN on 2 March 1998.

 

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 Central Secretariat 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 Central Secretariat 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, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

 

3X1.gif

 

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

 

Central Secretariat: rue de Stassart, 36 B-1050 Brussels

 

_______________

Ó 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

Ref. No. EN 12297:1998 E


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Obsah

 

strana

 

Contents

 

 

 

 

Foreword

3

1

Scope

3

2

Definitions

3

3

Testing

5

4

Documentation

7

Annex A (informative) Guidance on selection of sterilizability testing

8

Annex B (informative) Information on test methods for sterilizability

12

Annex C (informative) Bibliography

15


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Foreword

 

This European Standard has been prepared by Technical Committee  CEN/TC 233 „Biotechnology", the secretariat of which is held by AFNOR.

 

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  September 1998, and conflicting national standards shall be withdrawn  at the latest by September 1998.

 

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, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

 

1 Scope

 

This European Standard gives  guidance on general testing procedures to assess  the sterilizability for microorganisms equipment (components and units of equipment) used in biotechnological processes.

 

This European Standard gives  guidance on the assessment of the sterilizability of  biotechnological equipment with respect to a release of process microorganisms that  can affect the safety of the worker (occupational health)  and/or that can have adverse effects to the environment.

 

This European Standard is applicable to plants or components,  such as valves and fittings, tanks, pumps, piping, separating and filling devices as well as instrumentation in contact with process fluids.

 

This European Standard applies if the intended use of the equipment includes hazardous or potentially hazardous microorganisms.

 

This European  Standard is not  applicable to testing  for sterility of  media and equipment  prior to processing  or operation, respectively.

 

NOTE 1: For disinfection of external  surfaces such as walls,  working benches and floors,  attention is drawn to  national and European Standards.

 

NOTE 2: For sterilization of equipment and media  in autoclaves attention is drawn  to national and European standards  such as EN 285 and EN 554 (see annex [21], [22]).

 



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