BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
English
15-11-1997
31-07-2006
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 |
CH/198
|
| DevelopmentNote |
Supersedes 95/121171 DC. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN 866-1 : 1997 | Identical |
| DIN EN 866-1:1997-05 | Identical |
| NF EN 866-1 : 1997 | Identical |
| I.S. EN 866-1:1997 | Identical |
| NS EN 866-1 : 1ED 1997 | Identical |
| NEN EN 866-1 : 1997 | Identical |
| EN 866-1 : 1997 | Identical |
| UNE-EN 866-1:1997 | Identical |
| BS EN 866-3:1997 | Biological systems for testing sterilizers and sterilization processes Particular systems for use in moist heat sterilizers |
| BS EN 866-2:1998 | Biological systems for testing sterilizers and sterilization processes Particular systems for use in ethylene oxide sterilizers |
| BS EN 28601:1992 | Specification for representation of dates and times in information interchange |
| BS EN 1174-1:1996 | Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements |
| BS EN 868-1:1997 | Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods |
| EN 45014 : 1998 | GENERAL CRITERIA FOR SUPPLIER'S DECLARATION OF CONFORMITY |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| PREN 1422 : DRAFT 2011 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| EN ISO 9002:1994/AC:1997 | QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
| EN ISO 9003:1994/AC:1997 | QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST |
| BS EN 550:1994 | Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| BS EN 554:1994 | Sterilization of medical devices. Validation and routine control of sterilization by moist heat |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9003:1994 | Quality systems — Model for quality assurance in final inspection and test |
| EN 45001 : 1989 | GENERAL CRITERIA FOR THE OPERATION OF TESTING LABORATORIES |
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