JIS T 14971:2003

Name: JIS T 14971:2003
Brand: JSA

Superseded

View Superseded by

Medical devices - Application of risk management to medical devices

Available format(s)

Hardcopy , PDF

Superseded date

12-23-2016

Language(s)

English, Japanese

Published date

02-01-2004

Publisher

Japanese Standards Association

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This Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devcices and their accessories, including in vitro diagnostic medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control. The requirements of this International Standard are applicable to all stages of the life cycle of a medical device. This Standard does not apply to clinical judgements relating to the use of a medical device. It does not specify acceptable risk levels. This Standard does not require that the manufacturer has a formal quality system in place. However, risk management can be an integral part of a quality system.

DocumentType	Standard
Pages	36
PublisherName	Japanese Standards Association
Status	Superseded
SupersededBy	JIS T 14971:2012

Reaffirmed 2009

JIS T 7101:2006	Medical Gas Pipeline Systems
JIS T 7111:2006	Hose Assemblies For Use With Medical Gas Systems
JIS B 9918-1:2008	Cleanrooms and associated controlled environments - Biocontamination control Part 1: General principles and methods