AAMI/ISO 14971:2000/A1:2003 Historical

1126325

Medical Devices - Application of Risk Management to Medical Devices

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 08/26/2003

This item is not available for sale.

Track This

Full Description

This American National Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories (including in vitro diagnostic medical devices), estimate and evaluate the risks, control these risks, and monitor the effectiveness of the control.

Includes Amendment 1, Rationale for Requirements, June 2003. See more

Also Bought By Customers

 

Document History

  1. AAMI/ISO 14971:2019


    Medical devices - Application of risk management to medical devices

    • Most Recent

  2. AAMI/ISO 14971:2007/(R)2016


    Medical Devices - Application of Risk Management to Medical Devices

    • Historical Version

  3. AAMI/ISO 14971:2000/A1:2003

    👀 currently
    viewing


    Medical Devices - Application of Risk Management to Medical Devices

    • Historical Version

  4. AAMI 14971


    Risk management- Part 1: Application of risk management

    • Historical Version

Order Options

Unavailable

Product Details

Published:

08/26/2003

ISBN(s):

1570201498

ANSI:

ANSI Approved

Number of Pages:

57