BS EN 12347:1998
Current
The latest, up-to-date edition.
Biotechnology. Performance criteria for steam sterilizers and autoclaves
Hardcopy , PDF
English
15-08-1998
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.
Committee |
BTI/1
|
DevelopmentNote |
Supersedes 96/121395 DC. (08/2005)
|
DocumentType |
Standard
|
Pages |
12
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Supersedes |
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.
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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