Standard Swedish standard · SS-EN ISO 14971:2009

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Status: Withdrawn

· Replaced by: SS-EN ISO 14971:2012
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Standard Swedish standard · SS-EN ISO 14971:2009

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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Scope
Standarden specificerar en process för tillverkare att identifiera de risker som är förknippade med medicintekniska produkter och hjälper dig att utveckla ett ledningssystem för riskhantering. Standarden kräver att tillverkaren ska uppskatta, beräkna och bedöma riskerna hos sina produkter, kontrollera dessa risker, samt att övervaka riskhanteringens effektivitet. Kraven i standarden är tillämpliga på alla stadier i livscykeln för en medicinteknisk produkt. This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) 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 International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

Subjects

General (11.040.01) Quality management and corresponding general aspects for medical devices (11.110.10)


Buy this standard

Standard Swedish standard · SS-EN ISO 14971:2009

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Subscribe on standards - Read more Dölj
Price: 1 570 SEK
standard ikon pdf

PDF

Price: 1 570 SEK
standard ikon

Paper

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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-70410

Edition: 3

Approved: 7/23/2009

No of pages: 100

Replaces: SS-EN ISO 14971:2007

Replaced by: SS-EN ISO 14971:2012