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JIS T 14971:2012

JIS T 14971:2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices - Application of risk management to medical devices

Available format(s)

Hardcopy , PDF

Superseded date

19-11-2020

Language(s)

English, Japanese

Published date

01-09-2012

Publisher

Japanese Standards Association

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This Japanese Industrial Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this Standard are applicable to all stages of the life-cycle of a medical device.

DocumentType
Standard
Pages
94
PublisherName
Japanese Standards Association
Status
Superseded
SupersededBy
Supersedes

Reaffirmed 2016 2012(R2016) [25/10/2016]2012 [01/03/2012]2003(R2009) [25/04/2009]2003 [25/08/2003]

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Hardcopy - English
PDF - English
Hardcopy - Japanese
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