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DIN
DIN EN ISO 14155:2012-01

DIN EN ISO 14155:2012-01

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)

Available format(s)

Hardcopy , PDF

Superseded date

02-12-2020

Language(s)

German, English

Published date

01-01-2012

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Ethische Erwägungen
5 Planung der klinischen Prüfung
6 Durchführung der Prüfung
7 Aussetzung, Beendigung und Abbruch
  der klinische Prüfung
8 Verantwortlichkeiten des Sponsors
9 Verantwortung des Prüfleiters
Anhang A (normativ) Klinischer Prüfplan (CIP)
Anhang B (normativ) Prüferbroschüre (IB)
Anhang C (informativ) Prüfbögen (CRF)
Anhang D (informativ) Klinischer Prüfbericht
Anhang E (informativ) Wesentliche Dokumente der
          klinischen Prüfung
Anhang F (informativ) Entscheidungsbaum für die
          Klassifizierung von unerwünschten Ereignissen
Anhang ZA (informativ) Zusammenhang zwischen dieser
          Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG über
          Medizinprodukte
Anhang ZB (informativ) Zusammenhang zwischen dieser
          Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 90/385/EWG
          über aktive implantierbare Medizinprodukte
Literaturhinweise
Tabellen
Bilder

This standard is included in DIN HDBK 268.

DevelopmentNote
Supersedes DIN EN ISO 14155-1 and DIN EN ISO 14155-2. (01/2012)
DocumentType
Standard
Pages
68
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 14155:2011/AC:2011 Identical
ISO 14155:2011 Identical

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DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
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 EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
DIN EN ISO 11979-7:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
DIN EN ISO 11979-10:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014)
DIN EN ISO 11979-9:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
DIN EN ISO 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
DIN EN ISO 81060-2:2014-10 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVASTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013)
DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
DIN EN ISO 5840-1:2015-12 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
DIN EN ISO 10079-3:2014-09 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
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 7198:2017-07 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
DIN EN ISO 10079-1:2016-05 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN EN ISO 10079-2:2014-09 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014
DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN HDBK 268 : 3ED 2015 NICHT AKTIVE MEDIZINPRODUKTE - HORIZONTALE, HARMONISIERTE EUROPAEISCHE NORMEN GEMAESS EU-RICHTLINIEN AUF DEM GEBIET DER MEDIZIN

ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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Hardcopy - German
PDF - German
Hardcopy - English
PDF - English
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