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CAN/CSA-ISO 14971-01 PDF

CAN/CSA-ISO 14971-01 PDF

Name:
CAN/CSA-ISO 14971-01 PDF

Published Date:
09/01/2001

Status:
Active

Description:

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

Publisher:
Canada National Standard/Canadian Standards - ISO

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$27
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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)


File Size : 1 file , 1.9 MB
ISBN(s) : 1553246780
Number of Pages : 43
Published : 09/01/2001

History

CAN/CSA-ISO 14971-07 (R2017)
CAN/CSA-ISO 14971-07 (R2017)
Published Date: 05/01/2007
Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
$72.6
CAN/CSA-ISO 14971-01
CAN/CSA-ISO 14971-01
Published Date: 09/01/2001
Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2000, first edition, 2000-12-15)
$27

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