DIN EN ISO 5840:2009-08
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
Hardcopy , PDF
12-01-2015
English
01-01-2009
Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Abkürzungen
5 Grundlegende Anforderungen
6 Beschreibung des Geräts
7 Prüfung und Analyse zur Verifizierung/Validierung
der Konstruktion
Anhang A (informativ) Begründung für die
Festlegungen dieser Internationalen Norm
Anhang B (informativ) Gefährdungen bei
Herzklappenprothesen, damit zusammenhängende
Versagensmodi und Bewertungsverfahren
Anhang C (informativ) Leitlinien zur Risikobewertung
Anhang D (informativ) Physikalische und
Werkstoffeigenschaften von Herzklappenprothesen
Und ihrer Bauteile
Anhang E (informativ) Statistische Verfahren bei der
Anwendung von Leistungskriterien
Anhang F (informativ) In-vitro-Verfahren zur Prüfung
von stentlosen oder ähnlichen Klappen in
elastischen Kammern
Anhang G (informativ) Präklinische Prüfungen in vivo
Anhang H (informativ) Arbeitsvorschrift für die
Echokardiographie
Anhang I (informativ) Beschreibung der
Herzklappenprothese
Anhang J (informativ) Abbildungen von Beispielen von
Komponenten einiger Herzklappenprothesen
Anhang K (informativ) Beispiele anwendbarer Normen zur
Prüfung von Werkstoffen und
Bauteilen einiger Herzklappenprothesen
Anhang L (informativ) Anleitung zur Überprüfung des
hydrodynamischen Verhaltens
Anhang M (informativ) Prüfung der Dauerhaltbarkeit
Anhang N (informativ) Beispiele konstruktionsspezifischer
Prüfungen
Anhang O (informativ) Beurteilung der Ermüdungseigenschaften
Anhang P (normativ) Verpackung
Anhang Q (normativ) Kennzeichnung und Gebrauchsanleitung
Anhang R (normativ) Verfahren der Auswertung klinischer Daten
Anhang S (normativ) Sterilisation
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
Europäischen Norm und den grundlegenden
Anforderungen der EG-Richtlinie 93/42/EWG
Diese Internationale Norm legt Entwurfs- und minimale Leistungsspezifikationen für Herzklappenprothesen fest.
| DevelopmentNote |
Supersedes DIN EN 12006-1. (03/2006)
|
| DocumentType |
Standard
|
| Pages |
95
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 5840 : OCT 2009 | Identical |
| NBN EN ISO 5840 : 2009 | Identical |
| EN ISO 5840:2009 | Identical |
| UNI EN ISO 5840 : 2009 | Identical |
| BS EN ISO 5840:2009 | Identical |
| NS EN ISO 5840 : 2009 | Identical |
| NEN EN ISO 5840 : 2009 | Identical |
| ISO 5840:2005 | Identical |
| I.S. EN ISO 5840:2009 | Identical |
| SN EN ISO 5840 : 2009 | Identical |
| UNE-EN ISO 5840:2009 | Identical |
| VDI 5700 Blatt 1:2015-04 | Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
| 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 11607-1:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
| 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 |
| ISO 14160:2011 | 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 |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| DIN EN ISO 10993-2:2006-10 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006) |
| DIN EN ISO 8601:2002-03 (Draft) | DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| DIN EN ISO 11137-1:2015-11 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| DIN EN ISO 11137-3:2015-08 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| DIN EN ISO 14155-1:2009-11 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 532:1975 | Acoustics Method for calculating loudness level |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| 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) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| MIL-STD-1629 Revision A:1980 | PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
| IEC 60651:1979+AMD1:1993+AMD2:2000 CSV | Sound level meters |
| EN 12442-2 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
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