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CEN
EN 1174-1 : 1996

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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS

Superseded date

01-04-2006

Superseded by

EN ISO 11737-1:2018

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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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

Gives general criteria for the estimation of the population of viable micro-organisms on a medical device or a component, raw material or package. It consists of both enumeration and characterization of the population.

Committee
TC 204
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
02/565153 DC : DRAFT DEC 2002 BS EN 13795-2 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
DIN EN 13867:2009-09 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
DIN EN 13795-2:2009-12 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
DIN EN 13867:2003-01 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
EN 1174-2 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE
EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
EN 1174-3 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
I.S. EN 12442-3:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
99/124125 DC : DRAFT NOV 1999 BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS
I.S. EN 12442-1:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
BS EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
UNI EN 13867 : 2009 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
UNI EN 13795-1 : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
UNI EN 13795-2 : 2009 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
BS EN 13867 : 2002 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
BS EN 1174-2:1997 Sterilization of medical devices. Estimation of the population of micro-organisms on product Guidance
BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
BS EN 13795-2 : 2004 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
BS EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
I.S. EN 13795-1:2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
EN 866-1 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
EN 13795-2:2004+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
BS EN 13795-1 : 2002 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
I.S. EN 13795-2:2005 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 2: TEST METHODS
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
DIN EN 13795-1:2009-10 SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS

EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)

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