EN 866-1 : 1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
01-07-2006
12-01-2013
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Superseded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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