DIN EN ISO 14161:2010-03
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
Available format(s)
Hardcopy , PDF
Superseded date
07-03-2021
Language(s)
English
Published date
01-01-2010
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Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeines
5 Eigenschaften biologischer Indikatoren
6 Auswahl des Lieferanten
7 Biologische Indikatoren zur Verfahrensentwicklung
8 Biologische Indikatoren zur Validierung von
Sterilisationsverfahren
9 Biologische Indikatoren zur Routineüberwachung
10 Ergebnisse
11 Anwendung der Normen über biologische Indikatoren
12 Kulturbedingungen
13 Anforderungen Dritter
14 Schulung des Personals
15 Lagerung und Handhabung
16 Entsorgung biologischer Indikatoren
Anhang A (informativ) Mikrobiologische Inaktivierungskinetik
und Zählverfahren
Anhang B (informativ) Prüfkörper
Anhang C (informativ) Gleichungen für Fraktion-Negativ-Verfahren
zur D-Wert-Berechnung
Anhang D (informativ) Beispiele der Dokumentation für vom
Anwender hergestellte biologische Indikatoren
Anhang E (informativ) Berechnung des z-Wertes
Anhang F (informativ) Bestimmung des D-Wertes nach dem
Verfahren der Überlebenskurve
Anhang G (informativ) Reaktionsmerkmale für
Überleben/Keimabtötung
Literaturhinweise
This standard is included in DIN Handbook 263 and 265.
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| I.S. EN ISO 14161:2009 | Identical |
| NF EN ISO 14161 : 2009 | Identical |
| NS EN ISO 14161 : 2009 | Identical |
| UNI EN ISO 14161 : 2009 | Identical |
| NBN EN ISO 14161 : 2009 | Identical |
| SN EN ISO 14161 : 2010 | Identical |
| EN ISO 14161:2009 | Identical |
| UNE-EN ISO 14161:2010 | Identical |
| ISO 14161:2009 | Identical |
| BS EN ISO 14161:2009 | Identical |
| NEN EN ISO 14161 : 2009 | Identical |
| DIN EN ISO 11135:2014-10 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| DIN EN ISO 11140-1:2015-03 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| DIN EN ISO 13408-5:2011-09 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| DIN EN ISO 20857:2013-08 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| DIN EN ISO 14160:2011-10 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) |
| DIN HDBK 265 : 2ED 2012 | STERILISATION VON MEDIZINPRODUKTEN - INDIKATOREN UND VERPACKUNGEN FUER IN DER ENDVERPACKUNG ZU STERILISIERENDE MEDIZINPRODUKTE |
| DIN EN ISO 11138-5:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017) |
| DIN EN ISO 11138-3:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017) |
| DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| DIN EN ISO 11138-2:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
| DIN EN ISO 11138-4:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017) |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| DIN EN ISO 20857:2013-08 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN ISO 11138-3:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017) |
| DIN EN ISO 19011:2011-12 | GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011) |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| AAMI TIR31 : 2008 | PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
| DIN EN ISO 11138-2:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO/IEC 17011:2004 | Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| DIN EN ISO 17665-1:2006-11 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| DIN EN ISO 11135-1:2007-08 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| DIN EN ISO 9000:2015-11 | QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
| ISO 9001:2015 | Quality management systems — Requirements |
| DIN EN ISO 18472:2006-10 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| DIN EN ISO 11737-1:2009-09 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
| ISO 11138-4:2017 | Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes |
| DIN EN ISO 11138-5:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017) |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| DIN EN ISO/IEC 17011:2016-09 (Draft) | CONFORMITY ASSESSMENT - REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING CONFORMITY ASSESSMENT BODIES (ISO/IEC 17011:2017) |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| DIN EN ISO 11138-4:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017) |
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