EN 867-5:2001
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
02-28-2002
08-29-2001
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking, labelling and packaging
Annex A (normative) Small steam exposure apparatus and steam
for test purposes
Annex B (normative) Test cycles for evaluation of indicator
performance in the porous load process challenge
devices
Annex C (normative) Test cycles for evaluation of indicator
systems for use in hollow load process challenge
devices
Annex D (normative) Test cycles for evaluation of indicator
systems for use in hollow load process challenge
devices
Bibliography
This European Standard specifies the performance requirements and test methods for non-biological indicator systems, including the process challenge devices within which they are intended to function, to be used for testing the steam penetration performance of small steam sterilizers, Type B or Type S where ap-propriate. The test systems specified are intended for use only in small steam sterilizers Type B conforming to prEN 13060-2 and having a usable chamber space greater than 10 l and for small steam sterilizers Type S conforming to prEN 13060-4 also having a usable chamber space greater than 5 l.Non-biological indicator systems and the associate process challenge devices are specified for various types of load. The possible loads are considered in two classes: Porous loads, which can be wrapped or unwrapped, or hollow instrument loads, which also can be wrapped or unwrapped.The relevant section of this European Standard on porous loads specifies the requirements for:- a standard process challenge device to be used in the small load test for porous loads in small steam sterilizers;- an indicator system for use in the porous load process challenge device. An indicator for this purpose is a Class B indicator as described in EN 867-1.- an indicator employing an alternative process challenge device equivalent to the porous load process challenge device.The relevant section of this European Standard on hollow instruments specifies the requirements for:- hollow load process challenge devices to be used to simulate hollow instrument loads as defined in prEN 13060-4;- an indicator system, for use in one of the hollow load process challenge device, for assessing steam penetration in a wrapped load of hollow instruments. An indicator for this purpose is a Class B indicator as described in EN 867-1.The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to accommodate the proces
| Committee |
CEN/TC 102
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ONORM EN 867-5 : 2001 | Identical |
| DS EN 867-5 : 2001 | Identical |
| NF EN 867-5 : 2001 | Identical |
| UNI EN 867-5 : 2004 | Identical |
| NS EN 867-5 : 1ED 2001 | Identical |
| I.S. EN 867-5:2001 | Identical |
| PN EN 867-5 : 2003 | Identical |
| NEN EN 867-5 : 2001 | Identical |
| NBN EN 867-5 : 2001 | Identical |
| SN EN 867-5 : 2001 | Identical |
| UNE-EN 867-5:2002 | Identical |
| DIN EN 867-5:2001-11 | Identical |
| BS EN 867-5:2001 | Identical |
| I.S. EN 15424:2007 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 12/30261215 DC : 0 | BS EN 13060 - SMALL STEAM STERILIZERS |
| 11/30252448 DC : 0 | BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| PREN 14180 : DRAFT 2012 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| PREN 13060 : DRAFT 2012 | SMALL STEAM STERILIZERS |
| AAMI/ISO TIR17665-3:2014(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN 1422:2014-08 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| BS EN 15424:2007 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| DIN EN 1422:1997-11 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| DIN EN 15424:2007-08 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| PREN 1422 : DRAFT 2011 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| I.S. EN 285:2015 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| 12/30262894 DC : 0 | BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| 02/121895 DC : DRAFT APR 2002 | BS EN 13060 - SMALL STEAM STERILIZERS |
| PD ISO/TS 17665-3:2013 | Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| CSA Z17665-2:09 (R2019) | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15) |
| 13/30278676 DC : 0 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| UNI CEN ISO/TS 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| I.S. EN ISO 25424:2011 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN 13060:2014 | SMALL STEAM STERILIZERS |
| CSA Z17665-2:09 (R2019) | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| I.S. EN 14180:2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| I.S. EN 1422:2014 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| DIN EN 14180:2003-10 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| UNI EN ISO 25424 : 2011 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 17/30338806 DC : 0 | BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| EN 13060:2014 | Small steam sterilizers |
| DIN EN 13060:2015-03 | SMALL STEAM STERILIZERS |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| UNI EN 14180 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| UNI EN 1422 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 25424:2011-09 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN ISO 25424:2011 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| PREN 17180 : DRAFT 2017 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
| AAMI ISO TIR 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| AAMI/ISO TIR17665-2:2009(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| DIN EN 14180:2014-09 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| BS EN 13060 : 2014 | SMALL STEAM STERILIZERS |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| BS EN 14180:2014 | Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing |
| EN 15424:2007 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| DD CEN ISO/TS 17665-2:2009 | Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
| CSA Z17665-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| S.R. CEN ISO/TS 17665-2:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| AAMI ISO TIR 17665-3:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| UNE-EN 13060:2015 | Small steam sterilizers |
| UNE-EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| BS EN 1422:2014 | Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods |
| UNE-EN 285:2016 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| EN 20534 : 1993 | PAPER AND BOARD - DETERMINATION OF THICKNESS AND APPARENT BULK DENSITY OR APPARENT SHEET DENSITY |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 866-8 : 1999 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 8 - PARTICULAR REQUIREMENTS FOR SELF-CONTAINED BIOLOGICAL INDICATOR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS |
| EN 866-1 : 1997 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS |
| EN 866-4 : 1999 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 4 - PARTICULAR SYSTEMS FOR USE IN IRRADIATION STERILIZERS |
| EN 866-5 : 1999 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 5 - PARTICULAR SYSTEMS FOR USE IN LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS |
| EN 20187:1993 | Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990) |
| EN 867-2 : 1997 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - PROCESS INDICATORS (CLASS A) |
| EN 866-6 : 1999 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 6 - PARTICULAR SYSTEMS FOR USE IN DRY HEAT STERILIZERS |
| EN ISO 5457:1999/A1:2010 | TECHNICAL PRODUCT DOCUMENTATION - SIZES AND LAYOUT OF DRAWING SHEETS |
| EN 866-2:1997/AC:1998 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS |
| EN ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| EN 867-3:1997/AC:1998 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - SPECIFICATION FOR CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST |
| EN 867-1 : 1997 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS |
| EN 867-4 : 2000 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS- PART 4: SPECIFICATION FOR INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK TEST FOR THE DETECTION OF STEAM PENETRATION |
| EN 866-3 : 1997 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS |
| ISO 10012-1:1992 | Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment |
| EN ISO 10993-1:2009/AC:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
| EN 866-7 : 1999 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 7 - PARTICULAR REQUIREMENTS FOR SELF-CONTAINED BIOLOGICAL INDICATOR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS |
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