BS EN ISO 14155-2:2009

Superseded

View Superseded by

Clinical investigation of medical devices for human subjects Clinical investigation plans

Available format(s)

Hardcopy , PDF

Superseded date

28-02-2011

Language(s)

English

Published date

31-01-2010

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Status	Superseded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	BS EN ISO 14155:2011
Supersedes	BS EN ISO 14155-2:2003 01/562358 DC : DRAFT JUNE 2001

Standards	Relationship
EN ISO 14155-2:2009	Identical
NF 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
DIN EN ISO 14155-2:2009-11	Identical
NS EN ISO 14155-2 : 2009	Identical
DIN EN ISO 14155-2:2003-09	Identical

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)

View more information

$294.12

Including GST where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

BS EN ISO 14155-2:2009

Superseded

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription