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Overview of International

Medical Device Human

Factors Standards

Ed Israelski PhD,
Director of Human Factors
Abbott Park, IL, USA

 History of Medical Device Human Factors Standards

 Summary of major current international HF Standard
History of Medical Device HF Standards Development

Standard Title Main Purpose

Human Factors Engineering General design practices for user
ANSI/AAMI HE48: 1993 Guidelines and Preferred Practices interfaces (from MIL-STD 1472)
For the Design of Medical Devices Superseded by HE-75
HFE Process related to Design Controls
Human Factors Design Process in US 21CFR 820.30
ANSI/AAMI HE74: 2001
For Medical Devices

Medical Electrical Equipment - 2006 edition: HFE process applied to

IEC 60601-1-6: 2006.
General requirements for basic medical electrical equipment.
Now replaced by 2010
safety and essential performance - 2010 edition points to IEC 62366:2007
Collateral standard: Usability
 HFE process extended to all
Medical Devices – Application of medical devices with emphasis on
IEC 62366: 2007 Usability Engineering To Medical Risk Management and lifecyle
Devices  Harmonized by European Union as
EN 62366:2008
Interface design practices; special
Human Factors Engineering -
AAMI HE75: 2009 medical application issues; test &
Design of Medical Devices
evaluation methods
Other Medical Device Standards
Standard Title Main Purpose
IEC 60601-1:2005 Introduction to broad standard with
General safety & essential numerous subparts for a wide
ANSI/AAMI performance standard for variety of electrical medical
ES60601-1:2011, medical electrical equipment devices. (multiple subparts for type
3rd ed. acceptance)
Collateral to IEC 60601- Recommends visual and auditory
IEC 60601-1-8: 1:2005 on general alarm design parameters, e.g.
2006 requirements, tests and color, frequency and cadence.
guidance for alarm systems
Collects existing symbols
Graphical symbols for
IEC TR applicable to medical devices and
electrical equipment in
60878:2003 presents them in 15 medical device
medical practice
Medical devices – Symbols Part 1– Lists MDD + IVD Symbols
ISO 15223-1:2007 to be used with medical Part 2 – Symbol development,
ISO 15223-2:2010 device labels, labeling and selection and validation
information to be supplied
Other Medical Device Standards
Standard Title Main Purpose
Medical devices -- Application The definitive standard on principles
ISO 14971:2007 of risk management to of risk management, e.g. FTA,
medical devices FMEA to medical devices
- Collateral Standard: Describes particular requirements
Requirements for medical for home healthcare medical
IEC 60601-1-11: electrical equipment and devices
2011 medical electrical systems
used in the home healthcare
Small-bore connectors for Describes standard connectors that
liquids and gases in are usable and impossible to
ISO 80369 – healthcare applications - Part misconnect across medical device
1:2010 1: General Requirements categories
Parts 2 to 7 for particular
Used by Notified Bodies in EU and
IECEE – TRF’s TRF – Test Report Forms elsewhere to gauge compliance with
IEC/ISO standards
IEC 62366: Medical Devices –
Application of Usability Engineering to Medical Devices

 Usability Engineering process document like HE74 & IEC 60601-1-6

 IEC 60601-1-6:2010 essentially is a reference/pointer to IEC 62366:2007
– i.e. links IEC 62366:2007 into the IEC 60601-series for medical electrical
 Similar content to previous version (2007) of IEC 60601-1-6 with some
– “Medical Electrical equipment” changed to all medical devices
– “Operator” changed to “user”
– Includes Risk Management language (ISO 14971:2007)
– Has many more Informative Annexes
 Contains HE-74 as Annex D
 Although uses term “usability”, also stresses risk assessment and control
 IEC (EN) 62366:2008 harmonized under the European MDD directive as
of November 27, 2008
IEC 62366: Medical Devices: General Requirements for
Safety and Essential Performance-Usability

1: Scope The Manufacturer shall establish, document and

2: Normative references maintain a Usability Eng Process to provide safety
for the Patient, User and others... The process shall
address User interactions with the Medical Device…
3: Terms and definitions
4: Principles If the Usability Eng Process detailed in this ..
standard has been complied with and the
– 4.1 General Requirements acceptance criteria documented in the Usability
Validation Plan have been met, .. for the purposes
• 4.1.1 Usability Engineering
of ISO 14971, the residual risks associated with
Process usability of the device shall be .. acceptable, unless
• 4.1.2 Residual Risk there is objective evidence to the contrary.
• 4.1.3 Information for Safety
– 4.2 Usability EngineeringIf File
Information for Safety is a risk control, it shall be subjected
– 4.3 Scaling the Process to the Usability Eng Process..
..Usab. Eng Process may be scaled .. based on nature of
device…extent of modifications determined by risk analysis…
IEC 62366: Medical Devices: General Requirements for Safety
and Essential Performance-Usability

 5: Usability Engineering Process

– 5.1: Application Specification
– 5.2: Frequently Used Functions
– 5.3 Identification. Hazardous Situations ..shall provide testable requirements for
• 5.3.1 Identify characteristics related to Usability Verification; and .. for Usability of the
safety Primary Operating Functions including criteria
• 5.3.2 Identify known or foreseeable hazards for determining the adequacy of Risk Control
achieved by the Usab. Eng.Process.
– 5.4: Primary Operating Functions
.. criteria for determining successful Validation of
– 5.5: Usability Specification the usability of the Primary Oper. Functions based
– 5.6 Usability Validation Plan on the Usability Specification; and involvement of
representative users…May be quantitative or
– 5.7 User Interface Implementation
– 5.8 Usability Verification qualitative. Sim. Use environment..

– 5.9 Usability Validation

 6: Accompanying Document
 7: Training/Training Materials
Relationship of FDA HF Guidance to IEC 62366

Intended Use
 5: Usability Engineering Process
– 5.1: Application Specification FDA’s
– 5.2: Frequently Used Functions Preliminary
– 5.3 Ident. Hazardous Situations Evaluation
• 5.3.1 Identify characteristics related to
• 5.3.2 Identify known or foreseeable hazards FDA’s Formative
– 5.4: Primary Operating Functions Evaluation & Design
– 5.5: Usability Specification Mods
– 5.6 Usability Validation Plan
– 5.7 User Interface Implementation FDA’s
– 5.8 Usability Verification Validation
– 5.9 Usability Validation
 6: Accompanying Document
 7: Training/Training Materials
ANSI/AAMI HE74:2001: Human Factors Design
Process For Medical Devices

– Main Features
• Shows relationship of all HFE processes to design
cycle (Design Controls, etc.)
• Provides detail on recommended analysis and
testing methods with examples
– HE-74 has been incorporated into IEC 62366 as an
annex. It is no longer a stand-alone standard.
– Revisions to the HE-74 HFE process will be
incorporated in future revisions to IEC 62366
Future Revisions to IEC 62366:2007

• Feedback is that IEC 62366 could be more usable

• Fast Track Revision
– Add annex that will address process for:
• Legacy Devices,
• Changes to Legacy Devices
• Additions of accessories not subject to IEC 62366 (Usability of Unknown Provenance)
• Standard will be rewritten and split
– IEC 62366-1 (Shorter Normative Standard)
– IEC TR 62366-2 (Informative Tutorial Tech Report on Usability
Engineering for Medical Devices)
– Will be Harmonized with new FDA HF Guidance (draft June, 2011)
– Target is for 2014 Publication
Use Error Chart from IEC 62366:2007

Normal Use

Company Confidential 12
© 2009 Abbott
Example of a Fault Tree (FTA)

Incorrect Rx


Press Start Misprogrammed
Key Rx
incorrect Rx


Initial Program Change to Rx



Initial Loading
Delivery Mode PCA Dose Lockout Rate Dose Limit Concentration Units

Delivery Mode PCA Dose Lockout Rate Dose Limit
Loading Dose

Company Confidential 14
© 2009 Abbott
Example of a Fault Tree
Free T4 drift resulting in
falsely elevated FT4 result


Undetected drift-- due to Other causes for drift- see

microparticle deposition FMEA
Gate5 Event1

Q:3.75615e-011 Q:1e-006

Microparticle deposition in Controls failed to detect

bottle drift
Gate3 Gate6

Q:1.87808e-005 Q:2e-006

*Usage rate < 100 tests per Instrument left in Users/ lab consistently Controls run-- failed to
Insufficient agitation Reagent(s) left on-board
month or <500 test per month continuous run mode failed to run controls detect drift
Gate7 Event5 Event10 Event15 Event3 Event4

Q:0.000751982 Q:0.999 Q:0.05 Q:0.5 Q:1e-006 Q:1e-006

Manual swirl procedure failed to Automatic swirl procedure failed

remove microparticle deposition to remove microparticles
Gate8 Gate9

Q:0.0312 Q:0.024102

Swirl- insufficient Swirl done infrequently, Users failed to perform Electrical or mechanical Daily maintenance repeatedly interrupted Automatic swirl (within daily Automatic swirl failed to
magnitude intermittent deposition manual swirl failure- agitation failure before swirl completion maintenance) not performed. remove deposition
Event7 Event8 Gate12 Event11 Event12 Gate10 Event16

Q:0.0001 Q:0.0001 Q:0.031 Q:1e-006 Q:1e-006 Q:0.0011 Q:0.023

Users did not receive User failed to read instructions Automatic swirl software Operator failed to perform
notification. or forgot to manually swirl not installed. daily maintenance
Event18 Event19 Event13 Event14

Q:0.001 Q:0.03 Q:0.001 Q:0.0001

Company Confidential 15
© 2009 Abbott
Example of Use Error FMEA
Task Effectiveness Risk
# TASK Hazard Faults Prob Crit RI Method of Control of Control Acceptability Reference Category Notes
User fails to seat displayed/alarm/will
Delay in vial fully into not function if not Reduces to
Set-up therapy bottom bracket Occ Mod Med properly seated Low Acceptable
User fails to
squeeze cradle
release while Message
Damage pushing down on Displayed/alarm/will
to vial or top bracket to not function if not Will not
device seat vial. Rare Mod Low properly seated change Acceptable

Use non-Abbott Labeling on pump,

Patient tubing, causing manual and set Reduces to
overdose free flow Rare Maj Med requires Abbott sets Low Acceptable
User fails to
disconnect Message on pump
Infusion of patient and does reminds user to
Purging drug not purge line disconnect set and
the remaining before infusing must press and hold Will not
System in line another drug Occ Mod Low purge key to purge. change Acceptable
PCA line is
connected to
patient -
established as
secondary Labeling on pump,
Delay in instead of manual and set Will not
therapy primary line. Rare Mod Low requires Abbott sets change Acceptable

Company Confidential 16
© 2009 Abbott
 Human Factors Standards have been expanded, revised,
• Process Standards: (IEC 62366: 2007, HE-74)
• 62366 is now the usability engineering standard as 60601-
1-6:2010 (3rd ed.) is a “pointer” to it
• HE-74 has been phased out, incorporated into IEC 62366
as annex
• Design Principles: HE-75 replaces HE-48
• There are individual standards for Alarms, Symbols, Home
Devices and Risk Management that relate to HF
• More Standards being written (HF Complaints, Contextual
Inquiry, Healthcare IT)
• IEC 62366 will be split and updated by 2014