Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

02-01-2018

Publisher

International Organization for Standardization

ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies.

ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.

Committee	ISO/TC 157
DevelopmentNote	Supersedes ISO/DIS 11249. (02/2018)
DocumentType	Standard
Pages	23
ProductNote	THIS STANDARD ALSO REFERS TO ICH E3,ICH E6,ICH E8,ICH E9,MEDDEV 2.7.1
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
NEN ISO 11249 : 2018	Identical
BS ISO 11249:2018	Identical

MEDDEV 2.12-1 : REV 8 : 2013	GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
MEDDEV 2.12-2 : REV 2012	POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
ISO 7439:2015	Copper-bearing contraceptive intrauterine devices — Requirements and tests
ISO 15225:2016	Medical devices Quality management Medical device nomenclature data structure
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007	Medical devices Application of risk management to medical devices