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BS EN ISO 14155-2:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Clinical investigation plans
Available format(s)

Hardcopy , PDF

Superseded date

02-28-2011

Language(s)

English

Published date

01-31-2010

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (informative) - Case Report Forms
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential
                         Requirements of EU Directive
                         93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
                         Standard and the Essential
                         Requirements of EU Directive
                         90/385/EEC on Active Implantable
                         Medical Devices

Specifies requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices.

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.

This Standard does not apply to in vitro diagnostic medical devices.

Committee
CH/194
DevelopmentNote
Supersedes 01/562358 DC (06/2003)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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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