DIN EN ISO 14155-1:2009-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 1: GENERAL REQUIREMENTS
Hardcopy , PDF
01-01-2012
English
01-01-2009
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Superseded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 |
| Standards | Relationship |
| BS EN ISO 14155-1:2009 | Identical |
| EN ISO 14155-1:2009 | Identical |
| NF EN ISO 14155-1 : 2009 | Identical |
| UNE-EN ISO 14155-1:2009 | Identical |
| I.S. EN ISO 14155-1:2009 | Identical |
| UNI EN ISO 14155-1 : 2009 | Identical |
| NBN EN ISO 14155-1 : 2009 | Identical |
| SN EN ISO 14155-1 : 2010 | Identical |
| NEN EN ISO 14155-1 : 2009 | Identical |
| ISO 14155-1:2003 | Identical |
| NS EN ISO 14155-1 : 2009 | Identical |
| 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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