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EN 1441 MEDICAL DEVICES RISK ANALYSIS

EN 1441:1997 - risk analysis for medical devices ( including IVDs) is currently the Harmonised European Standard which specifies the risk analysis procedure to be taken.

It is due to be fully withdrawn by March 2004 and is expected to be replaced by EN ISO 14971:2000.

PROCEDURE

List characteristics that can affect safety
(List defined limits where appropriate)

 
Identify Hazards

 
Estimate Risks

 
Risk
Acceptable?
 

 

Reduce Risk by

  • Design
  • Safeguarding
  • Information

 
Risk
Acceptable?
 

 
REPORT

Note: Refer to the standard for the detailed process and should you require assistance contact David Baker.

In particular see Annex C for examples of possible hazards - a good check list which should be used in addition to expert evaluation of hazard and risk.

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tel: +44 (0) 1380 848170      fax: +44 (0) 1380 840152      david.baker@riskman.info