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EN 866-1 : 1997

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
Superseded date

07-01-2006

Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Test organisms and their preparation for the
    manufacture of inoculated carriers
6 Carriers and their inoculation
7 Packaging and labelling of inoculated carriers for
    distribution
8 Preparation of biological indicators from inoculated
    carriers
9 Packaging and labelling of biological indicators
10 Determination of test organism resistance
Annexes
A (normative) Determination of growth inhibition by
    carriers exposed to the sterilization process
B (normative) Determination of test organism resistance
C (informative) Relationship between the components of
    biological test systems
D (informative) Bibliography

Defines general requirements for manufacturing biological systems for use in testing sterilizers and sterilizing processes.

Committee
TC 102
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 866-1 : 1997 Identical
DIN EN 866-1:1997-05 Identical
BS EN 866-1:1997 Identical
UNI EN 866-1 : 1998 Identical
UNE-EN 866-1:1997 Identical
SN EN 866-1 : 1997 Identical
I.S. EN 866-1:1997 Identical
NF EN 866-1 : 1997 Identical
NS EN 866-1 : 1ED 1997 Identical
NEN EN 866-1 : 1997 Identical

BS EN 866-7:2000 Biological systems for testing sterilizers and sterilization processes Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers
BS EN 12347:1998 Biotechnology. Performance criteria for steam sterilizers and autoclaves
EN 12740:1999 Biotechnology - Laboratories for research, development and analysis - Guidance for handling, inactivating and testing of waste
EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
99/124125 DC : DRAFT NOV 1999 BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS
DIN EN 866-3:1997-05 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 3: PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
EN 866-6 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 6 - PARTICULAR SYSTEMS FOR USE IN DRY HEAT STERILIZERS
BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
BS EN 866-4:2000 Biological systems for testing sterilizers and sterilization processes Particular systems for use in irradiation sterilizers
BS EN 12740:1999 Biotechnology. Laboratories for research, development and analysis. Guidance for handling, inactivating and testing of waste
BS EN 866-8:2000 Biological systems for testing sterilizers and sterilization processes Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers
BS EN 866-6:2000 Biological systems for testing sterilizers and sterilization processes Particular systems for use in dry heat sterilizers
EN 866-8 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 8 - PARTICULAR REQUIREMENTS FOR SELF-CONTAINED BIOLOGICAL INDICATOR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS
EN 866-3 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
EN 866-5 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 5 - PARTICULAR SYSTEMS FOR USE IN LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS
EN 866-7 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 7 - PARTICULAR REQUIREMENTS FOR SELF-CONTAINED BIOLOGICAL INDICATOR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
EN 866-2:1997/AC:1998 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
EN 866-4 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 4 - PARTICULAR SYSTEMS FOR USE IN IRRADIATION STERILIZERS
02/124462 DC : DRAFT DEC 2002 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
02/121895 DC : DRAFT APR 2002 BS EN 13060 - SMALL STEAM STERILIZERS
BS EN 866-5:2000 Biological systems for testing sterilizers and sterilization processes Particular systems for use in low temperature steam and formaldehyde sterilizers

EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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