Catheters other than intravascular catheters – Test methods for common properties

DIN EN 1618:1997-04 (D)
Nicht-intravasale Katheter – Prüfverfahren für allgemeine Eigenschaften; Deutsche
Fassung EN 1618:1997
Inhalt Seite
Vorwort ……………………………………………………………………………………………………………………………………….. 2
1 Anwendungsbereich ………………………………………………………………………………………………………………….. 2
2 Prüfverfahren und Ergebnisse ……………………………………………………………………………………………………. 2
Anhang A (normativ) Prüfverfahren auf Korrosionsbeständigkeit der metallischen Bestandteile ……… 2
Anhang B (normativ) Verfahren zur Bestimmung der Reißfestigkeit ………………………………………………… 3
Anhang C (normativ) Prüfverfahren auf Flüssigkeitsdichtheit unter Druck ………………………………………. 4
Anhang D (normativ) Prüfverfahren für die Dichtheit bei Ansaugung oder im Vakuum …………………….. 4
Anhang E (normativ) Verfahren zur Bestimmung der Durchflußrate von Wasser durch den Katheter .. 5
Anhang F (normativ) Prüfverfahren für die Sicherheit der Konnektoren …………………………………………… 6
Anhang ZA (informativ) Abschnitte in dieser Europäischen Norm, die grundlegende
Anforderungen oder andere Vorgaben in EU-Richtlinien betreffen …………………………………… 7

Cardiovascular implants – Cardiac valve prostheses (ISO 5840:2005)

Abstract

 

ISO 5840:2005 is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.

It is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

ISO 5840:2005 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

ISO 5840:2005 imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.

DIN EN ISO 5840:2009-08 (D)
Herz- und Gefäßimplantate – Herzklappenprothesen (ISO 5840:2005); Deutsche
Fassung EN ISO 5840:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………6
4 Abkürzungen……………………………………………………………………………………………………………………….17
5 Grundlegende Anforderungen ……………………………………………………………………………………………..18
6 Beschreibung des Geräts…………………………………………………………………………………………………….18
7 Prüfung und Analyse zur Verifizierung/Validierung der Konstruktion ……………………………………23
Anhang A (informativ) Begründung für die Festlegungen dieser Internationalen Norm ……………………..35
Anhang B (informativ) Gefährdungen bei Herzklappenprothesen, damit zusammenhängende
Versagensmodi und Bewertungsverfahren…………………………………………………………………………..38
Anhang C (informativ) Leitlinien zur Risikobewertung ………………………………………………………………………41
Anhang D (informativ) Physikalische und Werkstoffeigenschaften von Herzklappenprothesen und
ihrer Bauteile……………………………………………………………………………………………………………………….50
Anhang E (informativ) Statistische Verfahren bei der Anwendung von Leistungskriterien …………………56
Anhang F (informativ) In-vitro-Verfahren zur Prüfung von stentlosen oder ähnlichen Klappen in
elastischen Kammern ………………………………………………………………………………………………………….57
Anhang G (informativ) Präklinische Prüfungen in vivo ……………………………………………………………………..59
Anhang H (informativ) Arbeitsvorschrift für die Echokardiographie ………………………………………………….62
Anhang I (informativ) Beschreibung der Herzklappenprothese………………………………………………………….66
Anhang J (informativ) Abbildungen von Beispielen von Komponenten einiger
Herzklappenprothesen…………………………………………………………………………………………………………68
Anhang K (informativ) Beispiele anwendbarer Normen zur Prüfung von Werkstoffen und
Bauteilen einiger Herzklappenprothesen………………………………………………………………………………74
Anhang L (informativ) Anleitung zur Überprüfung des hydrodynamischen Verhaltens………………………80
Anhang M (informativ) Prüfung der Dauerhaltbarkeit ………………………………………………………………………..88
Anhang N (informativ) Beispiele konstruktionsspezifischer Prüfungen……………………………………………..90
Anhang O (informativ) Beurteilung der Ermüdungseigenschaften …………………………………………………….92
Anhang P (normativ) Verpackung…………………………………………………………………………………………………….97
Anhang Q (normativ) Kennzeichnung und Gebrauchsanleitung………………………………………………………..98
Anhang R (normativ) Verfahren der Auswertung klinischer Daten…………………………………………………..100
Anhang S (normativ) Sterilisation…………………………………………………………………………………………………..102
Literaturhinweise…………………………………………………………………………………………………………………………..103
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG ……………………………………………..105

EN 12006-2:1998+A1:2009: Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 2: Vascular prostheses including cardiac valve conduits

DIN EN 12006-2:2009-08 (D)
Nichtaktive chirurgische Implantate – Besondere Anforderungen an Herz- und
Gefäßimplantate – Teil 2: Gefäßprothesen, einschließlich Herzklappen-Gefäßstutzen;
Deutsche Fassung EN 12006-2:1998+A1:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………5
1 Anwendungsbereich ……………………………………………………………………………………………………………..6
2 Normative Verweisungen ………………………………………………………………………………………………………6
3 Begriffe …………………………………………………………………………………………………………………………………7
4 Beabsichtigte Funktion………………………………………………………………………………………………………….7
5 Konstruktionsmerkmale ………………………………………………………………………………………………………..7
6 Werkstoffe …………………………………………………………………………………………………………………………….7
6.1 Biologische Verträglichkeit und biologische Stabilität ……………………………………………………………7
6.2 Chemische Eigenschaften — Nomenklatur…………………………………………………………………………….7
7 Beurteilung der Konstruktion ………………………………………………………………………………………………..7
7.1 Funktionsmerkmale……………………………………………………………………………………………………………….8
7.1.1 Verbundprothesen…………………………………………………………………………………………………………………8
7.1.2 Kombinierte Prothesen………………………………………………………………………………………………………….8
7.1.3 Kombinierte kardiovaskuläre Prothesen (Klappen-Konduit)……………………………………………………8
7.2 Anforderungen an Prothesen im Endzustand…………………………………………………………………………8
7.3 Probenahme………………………………………………………………………………………………………………………….9
7.4 Prüfverfahren ………………………………………………………………………………………………………………………..9
7.5 Vorklinische Bewertung in vivo ……………………………………………………………………………………………..9
7.6 Klinische Bewertung……………………………………………………………………………………………………………..9
7.7 Prüfberichte ………………………………………………………………………………………………………………………….9
8 Herstellung……………………………………………………………………………………………………………………………9
9 Sterilisation …………………………………………………………………………………………………………………………10
10 Verpackung…………………………………………………………………………………………………………………………10
11 Bereitstellung von Informationen durch den Hersteller…………………………………………………………10
Anhang A (normativ) Klassifizierung von Prothesen ………………………………………………………………………..11
Anhang B (informativ) Literaturverzeichnis ………………………………………………………………………………………12
Anhang C (informativ) Gegenüberstellung von EN 12006-2 und ISO/DIS 7198……………………………………13
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG ……………………………………………….15

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

Abstract

ISO 25539-1:2003 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

ISO 25539-1:2003 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.

ISO 25539-1:2003 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.

ISO 25539-1:2003 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.

ISO 25539-1:2003 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.

DIN EN ISO 25539-1:2009-08 (D)
Kardiovaskuläre Implantate – Endovaskuläre Implantate – Teil 1: Endovaskuläre
Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005); Deutsche Fassung EN ISO
25539-1:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………6
4 Beabsichtigte Funktion………………………………………………………………………………………………………….7
5 Konstruktionsmerkmale ………………………………………………………………………………………………………..7
5.1 Allgemeines ………………………………………………………………………………………………………………………….7
5.2 Einführsystem……………………………………………………………………………………………………………………….8
5.3 Implantat……………………………………………………………………………………………………………………………….8
6 Werkstoffe/Materialien …………………………………………………………………………………………………………..8
7 Bewertung der Konstruktion………………………………………………………………………………………………….9
7.1 Allgemeines ………………………………………………………………………………………………………………………….9
7.2 Einführsystem (und/oder endovaskuläres System) ………………………………………………………………10
7.3 Implantat……………………………………………………………………………………………………………………………..16
7.4 Vorklinische In-vivo-Bewertung……………………………………………………………………………………………24
7.5 Klinische Bewertung……………………………………………………………………………………………………………28
8 Herstellung………………………………………………………………………………………………………………………….31
9 Sterilisation …………………………………………………………………………………………………………………………32
9.1 Steril angelieferte Produkte………………………………………………………………………………………………….32
9.2 Unsteril angelieferte Produkte ……………………………………………………………………………………………..32
9.3 Sterilisationsrückstände………………………………………………………………………………………………………32
10 Verpackung…………………………………………………………………………………………………………………………32
10.1 Schutz vor Beschädigungen bei Lagerung und Transport…………………………………………………….32
10.2 Kennzeichnung……………………………………………………………………………………………………………………33
10.3 Durch den Hersteller bereitgestellte Informationen ………………………………………………………………34
Anhang A (informativ) Merkmale endovaskulärer Implantate — Technische und klinische
Überlegungen ……………………………………………………………………………………………………………………..35
Anhang B (informativ) Labor und analytische Prüfungen…………………………………………………………………50
Anhang C (informativ) Definitionen der meldepflichtigen klinischen Ereignisse ………………………………..55
Anhang D (informativ) Prüfverfahren………………………………………………………………………………………………..59
Anhang E (informativ) Ergänzung zum analytischen Ansatz bei der Prüfung der
Ermüdungsbeständigkeit und der Dauerhaftigkeit (pulsatil) nach D.5.3.19 ………………………….103
Literaturhinweise…………………………………………………………………………………………………………………………..106
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG ……………………………………………..108

Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO 25539-2:2008)

DIN EN ISO 25539-2:2013-05 (E)
Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO 25539-
2:2012)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………………………….
Introduction ……………………………………………………………………………………………………………………………………………………
1 Scope ………………………………………………………………………………………………………………………………………………….
2 Normative references ………………………………………………………………………………………………………………………..
3 Terms and definitions ………………………………………………………………………………………………………………………..
4 General requirements ………………………………………………………………………………………………………………………..
4.1 Classification ……………………………………………………………………………………………………………………………………..
4.2 Size ……………………………………………………………………………………………………………………………………………………..
4.3 Intended clinical use designation …………………………………………………………………………………………………….
5 Intended performance ……………………………………………………………………………………………………………………….
6 Design attributes ……………………………………………………………………………………………………………………………….
6.1 General ……………………………………………………………………………………………………………………………………………….
6.2 Delivery system and stent system ……………………………………………………………………………………………………
6.3 Implant ………………………………………………………………………………………………………………………………………………..
7 Materials ……………………………………………………………………………………………………………………………………………..
8 Design evaluation ………………………………………………………………………………………………………………………………
8.1 General ……………………………………………………………………………………………………………………………………………….
8.2 Sampling …………………………………………………………………………………………………………………………………………….
8.3 Conditioning of test samples ……………………………………………………………………………………………………………
8.4 Reporting ……………………………………………………………………………………………………………………………………………
8.5 Delivery system and stent system ……………………………………………………………………………………………………
8.6 Stent ……………………………………………………………………………………………………………………………………………………
8.7 Preclinical in vivo evaluation ……………………………………………………………………………………………………………27
8.8 Clinical evaluation ……………………………………………………………………………………………………………………………..
9 Post-market surveillance …………………………………………………………………………………………………………………..34
10 Manufacturing ……………………………………………………………………………………………………………………………………34
11 Sterilization ………………………………………………………………………………………………………………………………………..34
11.1 Products supplied sterile ………………………………………………………………………………………………………………….34
11.2 Products supplied non-sterile ………………………………………………………………………………………………………….35
11.3 Sterilization residuals ………………………………………………………………………………………………………………………..35
12 Packaging …………………………………………………………………………………………………………………………………………..35
12.1 Protection from damage in storage and transport ………………………………………………………………………….35
12.2 Marking ……………………………………………………………………………………………………………………………………………….35
12.3 Information supplied by the manufacturer ………………………………………………………………………………………36

EN 1060-3 :1997+A2:2009: Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electromechanical
blood pressure measuring systems (inc ludes Amendment A2:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
1 Scope ……………………………………………………………………………………………………………………………..4
2 Normative references ……………………………………………………………………………………………………..4
3 Definitions ………………………………………………………………………………………………………………………4
4 Cuff ………………………………………………………………………………………………………………………………..5
5 Display ……………………………………………………………………………………………………………………………6
6 Units ………………………………………………………………………………………………………………………………6
7 Requirements …………………………………………………………………………………………………………………6
8 Test methods ………………………………………………………………………………………………………………….9
9 Information supplied by the manufacturer ……………………………………………………………………..19
Annex A (informative) Bibliography ………………………………………………………………………………………………22
Annex ZA (informative) ####Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices$$$$ ………………………………….23

EN 1060-4 :2004: Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

Abstract

ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.

ISO 81060-1:2007 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement.

ISO 81060-1:2007 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.

DIN EN ISO 81060-1:2012-08 (E)
Non-invasive sphygmomanometers – Part 1: Requirements and test methods for nonautomated
measurement type (ISO 81060-1:2007)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 4
Introduction …………………………………………………………………………………………………………………………………… 5
1 * Scope ………………………………………………………………………………………………………………………….. 6
2 Normative references …………………………………………………………………………………………………….. 6
3 Terms and definitions …………………………………………………………………………………………………….. 7
4 Identification and marking ……………………………………………………………………………………………. 10
4.1 * Units of measurement ………………………………………………………………………………………………… 10
4.2 * Legibility of markings …………………………………………………………………………………………………. 10
4.3 * Durability of markings ………………………………………………………………………………………………… 10
4.4 * Marking of non-automated sphygmomanometer …………………………………………………………. 10
4.5 * Usability of reading …………………………………………………………………………………………………….. 11
4.6 Marking of the cuff ……………………………………………………………………………………………………….. 11
4.7 Marking of the non-automated sphygmomanometer packaging …………………………………….. 11
5 General requirements for testing non-automated sphygmomanometers ………………………… 12
5.1 * Type tests ………………………………………………………………………………………………………………….. 12
5.2 * Representative sample ……………………………………………………………………………………………….. 12
5.3 Environmental conditions …………………………………………………………………………………………….. 12
5.4 Repairs and modifications ……………………………………………………………………………………………. 12
5.5 * Humidity preconditioning treatment ……………………………………………………………………………. 12
6 General requirements …………………………………………………………………………………………………… 13
6.1 General ………………………………………………………………………………………………………………………… 13
6.2 Electrical safety ……………………………………………………………………………………………………………. 13
6.3 Mechanical safety …………………………………………………………………………………………………………. 13
6.4 Mechanical strength ……………………………………………………………………………………………………… 13
7 Requirements ………………………………………………………………………………………………………………. 15
7.1 Pressure indicating means …………………………………………………………………………………………… 15
7.2 Pneumatic system ………………………………………………………………………………………………………… 16
7.3 * Tamper proofing or unauthorized access ……………………………………………………………………. 19
7.4 Dynamic response in normal use ………………………………………………………………………………….. 19
8 Additional requirements for non-automated sphygmomanometer with mercury
manometer …………………………………………………………………………………………………………………… 20
8.1 * Internal diameter of the tube containing mercury ………………………………………………………… 20
8.2 * Portable non-automated sphygmomanometer …………………………………………………………….. 20
8.3 * Prevention of mercury spillage during transport …………………………………………………………. 20
8.4 * Prevention of mercury spillage in normal use ……………………………………………………………… 20
8.5 Quality of the mercury ………………………………………………………………………………………………….. 21
9 Non-automated sphygmomanometers with aneroid manometer ……………………………………. 21
9.1 * Scale mark at zero ……………………………………………………………………………………………………… 21
9.2 * Zero …………………………………………………………………………………………………………………………… 21
9.3 Hysteresis error ……………………………………………………………………………………………………………. 21
9.4 * Construction and materials ………………………………………………………………………………………… 22

10 Cleaning, sterilization and disinfection …………………………………………………………………………. 22
10.1 Reusable non-automated sphygmomanometer and parts ……………………………………………… 22
10.2 Non-automated sphygmomanometer and parts requiring processing before use ………….. 22
10.3 Non-automated sphygmomanometer and parts delivered sterile …………………………………… 23
11 Biocompatibility …………………………………………………………………………………………………………… 23
12 Information supplied by the manufacturer ……………………………………………………………………. 23
12.1 Accompanying document …………………………………………………………………………………………….. 23
12.2 Instructions for use ……………………………………………………………………………………………………… 23
12.3 Technical description …………………………………………………………………………………………………… 26
Annex A (informative) Rationale and guidance …………………………………………………………………………….. 28
Annex B (informative) Advice regarding non-automated sphygmomanometers with a mercury
manometer ………………………………………………………………………………………………………………….. 36
Annex C (informative) Environmental aspects ……………………………………………………………………………… 37
Annex D (informative) Reference to the essential principals …………………………………………………………. 38
Annex E (informative) Terminology — Alphabetized index of defined terms ………………………………….. 40
Bibliography ……………………………………………………………………………………………………………………………….. 41
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices ……………………………………….. 43

Sterile, single-use intravascular catheters – Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

DIN EN ISO 10555-1:2013-11 (E nglisch)
Intravascular catheters – Sterile and single-use catheters – Part 1: General req
uirements (ISO 10555-1:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
1 Scope …………………………………………………………………………………………………………………………….. 4
2 Normative references …………………………………………………………………………………………………….. 4
3 Terms and definitions …………………………………………………………………………………………………….. 4
4 Requirements ………………………………………………………………………………………………………………… 7
4.1 General ………………………………………………………………………………………………………………………….. 7
4.2 Radio-detectability …………………………………………………………………………………………………………. 7
4.3 Biocompatibility …………………………………………………………………………………………………………….. 7
4.4 Surface ………………………………………………………………………………………………………………………….. 7
4.5 Corrosion resistance ……………………………………………………………………………………………………… 7
4.6 Peak tensile force …………………………………………………………………………………………………………… 7
4.7 Freedom from leakage ……………………………………………………………………………………………………. 8
4.8 Hubs ……………………………………………………………………………………………………………………………… 8
4.9 Flowrate …………………………………………………………………………………………………………………………. 8
4.10 Power injection ………………………………………………………………………………………………………………. 8
4.11 Side holes ……………………………………………………………………………………………………………………… 8
4.12 Distal tip ………………………………………………………………………………………………………………………… 8
5 Designation of nominal size ……………………………………………………………………………………………. 8
5.1 Outside diameter ……………………………………………………………………………………………………………. 8
5.2 Nominal effective length …………………………………………………………………………………………………. 9
6 Information to be supplied by the manufacturer ……………………………………………………………… 9
6.1 General ………………………………………………………………………………………………………………………….. 9
6.2 Marking on the device and/or primary packaging ……………………………………………………………. 9
6.3 Instructions for use ………………………………………………………………………………………………………. 10
6.4 Marking on the secondary packaging ……………………………………………………………………………. 10
Annex A (normative) Test method for corrosion resistance ………………………………………………………….. 11
Annex B (normative) Method for determining peak tensile force …………………………………………………… 12
Annex C (normative) Test method for liquid leakage under pressure …………………………………………….. 14
Annex D (normative) Test method for air leakage into hub assembly during aspiration …………………. 16
Annex E (normative) Determination of flowrate through catheter ………………………………………………….. 18
Annex F (normative) Test for burst pressure under static conditions ……………………………………………. 20
Annex G (normative) Power injection test for flowrate and device pressure (only for products
indicated for power injection) ……………………………………………………………………………………….. 22
Annex H (informative) Units of measurement systems other than those specified in this part of ISO
10555, which may additionally be used …………………………………………………………………………. 25
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC ……………….. 27
Bibliography ……………………………………………………………………………………………………………………………….. 29