2705507

DANSK DS/EN ISO 14971 [ Revised ]

Medical devices – Application of risk management to medical devices

standard by Dansk Standard , 12/21/2012

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BILINGUAL

ISO 14971:2007 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 ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

 

Product Details

Edition:
12
Published:
12/21/2012
Number of Pages:
206
File Size:
1 file , 2.5 MB
Product Code(s):
DS-181, DS-181
 

Document History

  1. DANSK DS/EN ISO 14971


    Medical devices – Application of risk management to medical devices (ISO 14971:2019)

    • Most Recent

  2. DANSK DS/EN ISO 14971

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    Medical devices – Application of risk management to medical devices

    • Historical Version

  3. DANSK DS/EN ISO 14971


    Medical devices - Application of risk management to medical devices

    • Historical Version

  4. DANSK DS/EN ISO 14971


    Medical devices - Application of risk management to medical devices

    • Historical Version

  5. DANSK DS/EN ISO 14971


    Medical devices - Application of risk management to medical devices

    • Historical Version

  6. DANSK DS/EN ISO 14971


    Medical devices - Application of risk management to medical devices

    • Historical Version