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DIN
DIN EN ISO 5840:2009-08

DIN EN ISO 5840:2009-08

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES

Available format(s)

Hardcopy , PDF

Superseded date

01-12-2015

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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

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)
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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Hardcopy - English
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