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BS EN 12347:1998

Current
Current

The latest, up-to-date edition.

Biotechnology. Performance criteria for steam sterilizers and autoclaves
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-15-1998

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Hazards
5 Performance classification
6 Classification of steam sterilizers and autoclaves
7 Verification of performance
8 Marking and packaging
9 Documents
Annex A (informative) Bibliography

Defines performance criteria for steam sterilizers and autoclaves for destroying and preventing the release of microorganisms in biotechnological processes. Applicable when the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms in biotechnological processes, or if exposing the worker or environment to such microorganisms is restricted for safety reasons.

This European Standard specifies performance criteria for steam sterilizers and autoclaves used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechnological processes, or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

Additional criteria for individual components of a steam sterilizer or autoclave, such as filters, couplings, pipes, are given in European Standards on biotechnology pertaining to performance criteria for filter elements, filtration equipment, tubes and pipes and couplings, which are being prepared.

Committee
BTI/1
DevelopmentNote
Supersedes 96/121395 DC. (08/2005)
DocumentType
Standard
Pages
12
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
UNE-EN 12347:1998 Identical
UNI EN 12347 : 2000 Identical
NBN EN 12347 : 1998 Identical
I.S. EN 12347:1998 Identical
NS EN 12347 : 1ED 1999 Identical
NEN EN 12347 : 1998 Identical
DIN EN 12347:1998-06 Identical
SN EN 12347 : 1998 Identical
EN 12347:1998 Identical
NF EN 12347 : 1998 Identical

EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN 1620:1996 Biotechnology - Large-scale process and production - Plant building according to the degree of hazard
EN 866-1 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
EN 1672-2:2005+A1:2009 Food processing machinery - Basic concepts - Part 2: Hygiene requirements
EN 1619:1996 Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
EN 867-2 : 1997 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - PROCESS INDICATORS (CLASS A)
EN 867-1 : 1997 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS
EN 866-3 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
ISO 4287-1:1984 Surface roughness — Terminology — Part 1: Surface and its parameters
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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