ISO 14971

OVERVIEW OF CHANGES IN ISO 14971

CLARIFICATION

A
Clause 2

Z https://
CORRECTED

Some new / adapted Clarification of several New Clause 2 on Additional guidance Corrections of minor
definitions (aligned requirements with more normative references (in companion report (editorial) errors and
with GHTF and ISO detail (per ISO-IEC ISO TR 24971) inaccuracies
13485) Directives)

NEW NEW

1 BENEFIT 3 REASONABLY FORESEEABLE MISUSE

Positive impact or desirable outcome of the use of a medical Use of a product or system in a way not intended by the
device on the health of an individual, or a positive impact on manufacturer, but which can result from readily
patient management or public health predictable human behaviour

Benefits can include positive impact on clinical outcome, the Readily predictable human behaviour includes the behaviour
patient’s quality of life, outcomes related to diagnosis, positive of all types of users, e.g. lay and professional users
impact from diagnostic devices on clinical outcomes, or positive Reasonably foreseeable misuse can be intentional or unintentional
impact on public health

DEFINITION
ADAPTED OF:
2 HARM This term is different from
Injury or damage to the health of people, or USE ERROR
damage to property or the environment
Reasonably foreseeable misuse includes use error
and the reasonably foreseeable part of abnormal use
(Deletion of “physical”, in line with
ISO-IEC Guide 51:2014)
 USE/MISUSE OF MEDICAL DEVICES

Risk management, ISO 14971

Usability engineering, BS EN 62366-1

Correct use:
Intended use
Other use
Normal (maintenance, transport,
Reasonably use stand-by, etc.)
foreseeable
use/misuse Use error
(part of reasonably
foreseeable misuse)

Abnormal use
(part of reasonably foreseeable misuse)

Not reasonably Part of abnormal use, but not

foreseeable reasonably foreseeable,
use/misuse therefore out of scope
 Risk evaluation: Risk analysis: Risk control measures:

Against acceptability Determine intended use, • Inherently safe design

criteria documented in reasonably foreseeable
the RM plan misuse, characteristics • Protective measures
related to safety New/adapted in ISO 14971:2019
• Information for safety
Identify all hazards,
PLAN hazardous situations,
events, possible harm Information for training
RISK
Estimate associated risks

All activities must be planned

More emphasis on
benefit-risk balance

Criteria for risk acceptability

must be based on: 1 2 3
Risk
regulations, Risk assessment Risk control
management BENEFIT
international standards, plan Definition of “benefit”
state-of-the-art,
stakeholder concerns

RISK MANAGEMENT BY ISO 14971

Define method and
Establish and maintain system Production and Risk Evaluation of
RERISK
MANAGEMEN

PLAN
criteria in risk
to actively collect/review post-production management overall residual management plan
information activities review risk
Collect information (sources) 6 5 4
Review information on
relevance to safety (benefits,
state of the art) Actions for medical Record and Evaluate all risks Improved/adapted in ISO 14971:2019
device and risk REPORT maintain as the together in relation to
management Risk Management the benefits (in one
process Report instead of two steps)

Ensure that overall Ensure methods to Inform users of significant

residual risk is collect/review residual risks (disclosure)
acceptable

Review execution
(post)-production
info are in place 14971
of risk management RISKS
plan BENEFITS