BS EN 1174-1:1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements
Hardcopy , PDF
English
15-08-1996
28-04-2006
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General
5 Selection of product
6 Selection of technique
7 Validation of technique
8 Revalidation
9 Use of technique
Annexes
A (informative) Bibliography
ZA (informative) Clauses of this European Standard addressing
essential requirements or other provisions of EU
Directives
Specifies general criteria for estimating bioburden on a medical device, raw material or package.
| Committee |
CH/198
|
| DevelopmentNote |
Reviewed and confirmed by BSI, March, 2005. (03/2005) Supersedes 93/507344 DC. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 1174-1 : 1996 | Identical |
| NF EN 1174-1 : 1996 | Identical |
| NBN EN 1174-1 : 1996 | Identical |
| NEN EN 1174-1 : 1996 | Identical |
| NS EN 1174-1 : 1ED 1996 | Identical |
| I.S. EN 1174-1:1996 | Identical |
| DIN EN 1174-1 E : 1996 | Equivalent |
| DIN EN 1174-1:1996-03 | Identical |
| UNE-EN 1174-1:1996 | Identical |
| BS EN 866-1:1997 | Biological systems for testing sterilizers and sterilization processes General requirements |
| BS EN 1174-3:1997 | Sterilization of medical devices. Estimation of the population of micro-organisms on product Guide to the methods for validation of microbiological techniques |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| BS EN ISO 9001:2015 | Quality management systems. Requirements |
| EN 29004 : 1987 | QUALITY MANAGEMENT & QUALITY SYSTEM ELEMENTS - GUIDELINES |
| EN 724 : 1994 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES |
| EN ISO 9002:1994/AC:1997 | QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| BS EN 46001:1997 | Specification for application of EN ISO 9001 to the manufacture of medical devices |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
| EN 45001 : 1989 | GENERAL CRITERIA FOR THE OPERATION OF TESTING LABORATORIES |
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