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BS EN 1174-1:1996

BS EN 1174-1:1996

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements

Available format(s)

Hardcopy , PDF

Superseded date

04-28-2006

Language(s)

English

Published date

08-15-1996

Publisher

British Standards Institution

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Superseded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
SN EN 1174-1 : 1996 Identical
UNI EN 1174-1 : 1996 Identical
UNE-EN 1174-1:1996 Identical
DIN EN 1174-1:1996-03 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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Hardcopy - English
PDF - English
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