DIN EN ISO 11135-1:2007-08
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
01-10-2014
English
01-01-2007
Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Qualitätsmanagementsysteme
4.1 Dokumentation
4.2 Verantwortlichkeit der Leitung
4.3 Produktrealisierung
4.4 Messung, Analyse und Verbesserung - Lenkung
fehlerhafter Produkte
5 Charakterisierung des sterilisierenden Agens
5.1 Sterilisierendes Agens
5.2 Keimabtötende Wirkung
5.3 Auswirkungen auf Materialien
5.4 Überlegungen zur Umwelt
6 Charakterisierung von Verfahren und Ausrüstung
6.1 Charakterisierung des Verfahrens
6.2 Charakterisierung der Ausrüstung
7 Produktdefinition
7.1 Allgemeines
7.2 Produktsicherheit und Produktleistung
7.3 Mikrobiologische Qualität
7.4 Dokumentation
8 Verfahrensdefinition
9 Validierung
9.1 Abnahmebeurteilung
9.2 Funktionsbeurteilung
9.3 Leistungsbeurteilung
9.4 Wechselnde Konfigurationen der Beladung
9.5 Überprüfung und Bestätigung der Validierung
10 Lenkung der Anwendung und Kontrolle
11 Produktfreigabe nach der Sterilisation
12 Aufrechterhaltung der Wirksamkeit des Verfahrens
12.1 Allgemeines
12.2 Instandhaltung der Ausrüstung
12.3 Erneute Beurteilung
12.4 Beurteilung von Veränderungen
Anhang A (normativ) Bestimmung der keimabtötenden
Wirkung des Prozesses - Verfahren mit
biologischen Indikatoren und der
Keimbelastung
Anhang B (normativ) Konservative Bestimmung der keimabtötenden
Wirkung des Prozesses - Keimabtötung
über das übliche Mass hinaus ('Overkill')
Anhang C (informativ) Allgemeiner Leitfaden
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
Europäischen Norm und den
grundlegenden Anforderungen der
EG 93/42/EWG über Medizinprodukte
This standard is included in DIN Handbook 169, 267/2, 268 and 263. Describes requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
| DevelopmentNote |
Supersedes DIN EN ISO 11135 issue 08-2004. (01/2006) Supersedes DIN 58948-6, DIN EN 550. (08/2007)
|
| DocumentType |
Standard
|
| Pages |
49
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 11135-1:2007 | Identical |
| BS EN ISO 11135-1:2007 | Identical |
| I.S. EN ISO 11135-1:2007 | Identical |
| ISO 11135-1:2007 | Identical |
| SN EN ISO 11135-1 : 2007 | Identical |
| UNE-EN ISO 11135-1:2007 | Identical |
| UNI EN ISO 11135-1 : 2008 | Identical |
| NF EN ISO 11135-1 : 2007 | Identical |
| DIN HDBK 267/2 : 2ED 2014 | |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| DIN EN ISO 25539-3:2012-03 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| DIN EN ISO 10555-6:2017-11 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015) |
| DIN EN ISO 22803:2006-01 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| VDI/VDE 3516 Blatt 2:1981-07 | Process analytical equipment for fluids |
| DIN EN ISO 22794:2009-11 | Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
| DIN EN ISO 13504:2012-10 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
| DIN EN ISO 25539-2:2013-05 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| 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 EN ISO 14161:2010-03 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| DIN EN ISO 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| DIN EN ISO 5840-3:2013-06 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| DIN HDBK 263 : 4ED 2014 | |
| DIN ISO 11040-4:2007-10 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| 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 |
| IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| 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 |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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