CAN/CSA-ISO 14971-01 Historical

928815

Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2000, first edition, 2000-12-15)

standard by Canada National Standard/Canadian Standards - ISO , 09/01/2001

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Full Description

This International 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.

The requiremetns 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 judgements relating to the use of a medical device.

It does not specify acceptable risk levels.

This International 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 (see, for example, Table G.1) See more

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Document History

  1. CAN/CSA-ISO 14971-07 (R2017)


    Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)

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  2. CAN/CSA-ISO 14971-01

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    Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2000, first edition, 2000-12-15)

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Amendments, rulings, supplements, and errata

  1. CAN/CSA-ISO 14971A-01


    Amendment 1:2003 to CAN/CSA-ISO 14971-01, Medical Devices - Applicaton of Risk Management to Medical Devices - Amendment 1: Rationale for Requirements (Adopted Amendment 1:2003 to ISO 14971:2000)

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Product Details

Published:

09/01/2001

ISBN(s):

1553246780

Number of Pages:

43

File Size:

1 file