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DIN
DIN EN ISO 14155-2:2009-11

DIN EN ISO 14155-2:2009-11

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2: CLINICAL INVESTIGATION PLANS

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Superseded date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 Anforderungen
Anhang A (informativ) Prüfbogen (CRF)
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 requirements for the preparation of a Clinical Investigation Plan (CIP) for clinical investigation of medical devices.

DevelopmentNote
Supersedes DIN EN 540. (10/2003)
DocumentType
Standard
Pages
17
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

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 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)

ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

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Hardcopy - English
PDF - English

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