DIN EN ISO 14155-2:2009-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
Hardcopy , PDF
01-01-2012
English
01-01-2009
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Superseded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 |
| Standards | Relationship |
| EN ISO 14155-2:2009 | Identical |
| NF EN ISO 14155-2 : 2009 | Identical |
| BS EN ISO 14155-2:2009 | Identical |
| I.S. EN ISO 14155-2:2009 | Identical |
| UNI EN ISO 14155-2 : 2009 | Identical |
| NBN EN ISO 14155-2 : 2009 | Identical |
| NEN EN ISO 14155-2 : 2009 | Identical |
| SN EN ISO 14155-2 : 2010 | Identical |
| UNE-EN ISO 14155-2:2009 | Identical |
| ISO 14155-2:2003 | Identical |
| NS EN ISO 14155-2 : 2009 | Identical |
| 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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