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ISO 14971 Changed

While the core text of ISO 14971 on risk management for medical devices remains unchanged, the 2012 version (EN ISO 14971:2012) was released to support European Directives. It includes three new annexes (ZA, ZB, ZC) describing seven content deviations required to ensure conformity with the Essential Requirements of the Directives. For manufacturers selling in Europe, a review of processes against the applicable annex is needed to identify any procedure updates. However, the standard requirements outside of Europe are unchanged. The seven deviations relate to issues like treatment of negligible risks, risk acceptability assessment, and considering economic factors in risk reduction.

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598 views1 page

ISO 14971 Changed

While the core text of ISO 14971 on risk management for medical devices remains unchanged, the 2012 version (EN ISO 14971:2012) was released to support European Directives. It includes three new annexes (ZA, ZB, ZC) describing seven content deviations required to ensure conformity with the Essential Requirements of the Directives. For manufacturers selling in Europe, a review of processes against the applicable annex is needed to identify any procedure updates. However, the standard requirements outside of Europe are unchanged. The seven deviations relate to issues like treatment of negligible risks, risk acceptability assessment, and considering economic factors in risk reduction.

Uploaded by

Sen Ming
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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www.nevi l l ecl arke.

com
ISO 14971 (Medical devices Application
of Risk Management to Medical Devices)
CHANGED?
If you ask whether ISO 14971 standard requirements have changed, the
answer would be YES and NO.
In August 2012, EN ISO 14971:2012 has been released and superseded
EN ISO 14971:2009 to support the Directves. The changes are described
in Annex ZA, ZB and ZC, the core text of the standard remains unchanged.
This is triggered when compliance with the normatve clauses in ISO
14971 does not ensure conformity with the Essental Requirements (ERs)
of the Directves. In this latest development, EN ISO 14971:2012 has listed
a total of 7 Content Deviatons to further explain the requirements from
the ER.
Therefore, YES EN ISO 14971 has changed and if a manufacturer has products associated with the European market and need to
comply with the Directves, the manufacturer shall conduct a detailed review of current risk management processes in reference
to the applicable Annex ZA, ZB, or ZC in EN ISO 14971:2012 to plan for any updates to risk-related procedures as necessary.
However, for the rest of the world, NO There is no change in the requirements and their risk management process shall conform
to the ISO 14971:2007 standard requirements.
The 7 Content Deviatons are listed below:
1. Treatment of Negligible Risks:
ISO 14971 allows negligible risks to be ignored.
The Directves require all risks to be reduced as far as possible and to be subject to risk-beneft analysis.
2. Risk Acceptability Assessment:
ISO 14971 allows risks that meet the manufacturers defniton of acceptable to be excluded from overall risk-beneft
analysis.
The Directves require all risks to be reduced as far as possible and to be subject to risk-beneft analysis.
3. Risk Reducton Economic Consideratons:
ISO 14971 allows risks to be reduced as low as reasonably practcable (ALARP).
The Directves require all risks to be reduced as far as possible (AFAP) without economic consideratons.
4. Risk-Beneft Analysis Not Optonal:
ISO 14971 only requires risk-beneft analysis for risks that do not meet the manufacturers defniton of acceptable.
The Directves always require risk-beneft analysis, regardless of risk levels. The analysis must consider all individual risks
and their impact on overall residual risk acceptability, weighing all risks combined against patent beneft.
5. Risk Control Optons:
ISO 14971 describes three risk control optons to be exercised at the manufacturers discreton(1) inherent safety by
design, (2) protectve measures, and (3) informaton for safetyand implies that further controls are not required if the risk
is reduced to acceptable levels.
The Directves require risks to be reduced untl further control measures do not result in risk reducton.
6. First Risk Control Opton:
ISO 14971 describes the frst risk control measure as inherent safety by design without further detail.
The Directves provide additonal detail by mentoning that device design and constructon just conform to safety
principles, taking account of the generally acknowledged state of the art and that risks must be eliminated or reduced as
far as possible through inherently safe design and constructon.
7. Labeling Informaton Cannot Infuence Residual Risk:
ISO 14971 describes three risk control optons: (1) inherent safety by design, (2) protectve measures, and (3) informaton
for safety.
The Directves view the third opton as providing informaton on residual risk rather than reducing risk.
ISO 14971 May 2014 Page 1

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