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BS 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

31-07-2006

Language(s)

English

Published date

15-11-1997

Publisher

British Standards Institution

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Superseded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
UNE-EN 866-1:1997 Identical
SN EN 866-1 : 1997 Identical
NF EN 866-1 : 1997 Identical
UNI EN 866-1 : 1998 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

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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Hardcopy - English
PDF - English
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