• BS EN 12347:1998

    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:  15-08-1998

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee BTI/1
    Development Note Supersedes 96/121395 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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