EN 1174-2 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
12-01-2013
01-04-2006
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Superseded
|
| Standards | Relationship |
| I.S. EN 1174-2:1997 | Identical |
| NS EN 1174-2 : 1ED 1997 | Identical |
| AS EN 1174.2-2002 | Identical |
| NBN EN 1174-2 : 1997 | Identical |
| DIN EN 1174-2 E : 1997 | Identical |
| BS EN 1174-2:1997 | Identical |
| NEN EN 1174-2 : 1997 | Identical |
| NF EN 1174-2 : 1997 | Identical |
| UNE-EN 1174-2:1997 | Identical |
| DIN EN 1174-2:1997-02 | Identical |
| 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 |
| 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 |