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CEN
EN 1174-2 : 1996

EN 1174-2 : 1996

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

01-04-2006

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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Introduction
1 Scope
2 Normative reference
3 Definitions
4 General
    4.1 Operation of the laboratory
    4.2 Equipment and materials
    4.3 Microbiological media
5 Selection of technique
    5.1 General
    5.2 Elements of bioburden estimation
    5.3 Selection of media and incubation conditions
6 Validation of bioburden techniques
    6.1 General
    6.2 Validation of technique for removal of micro-
          organisms
    6.3 Validation of enumeration methods
7 Use of technique
    7.1 General
    7.2 Limit setting for process monitoring
    7.3 Trend analysis for process monitoring
    7.4 Sampling frequency for process monitoring
Annex A (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives

Gives guidelines on implementing requirements defined in EN 1174-1, to provide a better understanding in addition to giving assistance in implementation of its requirements. Intended not as an exhaustive guide, but to show important aspects requiring attention. Not intended to be a checklist for assessment of compliance with EN 1174-1.

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Superseded

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 866-7:2000 Biological systems for testing sterilizers and sterilization processes Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers
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
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
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 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
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
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
BS EN 13867 : 2002 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
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 866-3:1997 Biological systems for testing sterilizers and sterilization processes Particular systems for use in moist heat sterilizers
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
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 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 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - 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
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
BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes Particular systems for use in ethylene oxide sterilizers
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 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS

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