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DIN
DIN EN ISO 14155-1:2009-11

DIN EN ISO 14155-1:2009-11

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 1: GENERAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Superseded date

01-01-2012

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 Begründung der klinischen Prüfung
5 Ethische Erwägungen
6 Allgemeine Anforderungen
7 Dokumentation
8 Sponsor
9 Monitor
10 Klinischer Prüfer
11 Schlussbericht
Anhang A (informativ) Vorgeschlagenes Verfahren
          für den Literaturnachweis
Anhang B (informativ) Informationen für die
          Ethikkommissionen
Anhang C (informativ) Schlussberichte für klinische
          Prüfungen von Medizinprodukten
Literaturhinweise
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

Specifies procedures for the conduct and performance of clinical investigations of medical devices. Applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.

DevelopmentNote
Supersedes DIN EN 540. (10/2003)
DocumentType
Standard
Pages
30
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

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)
VDI 3823 Blatt 4:2006-11 Vacuum coating quality assurance - Testing of vacuum coated plastics
DIN EN ISO 21534:2009-08 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
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 7439:2015-08 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
DIN EN ISO 10993-10:2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
DIN EN ISO 14607:2009-08 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
DIN EN ISO 5840:2009-08 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES

ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
ISO 14971:2007 Medical devices Application of risk management to medical devices

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Hardcopy - English
PDF - English

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