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Global Medical Device Regulatory Strategy
Given the wide range of medical devices, from
thermometers to surgical tools, and the technol-
ogies in use, an encyclopedia of hazards and risk
mitigation measures would be large, unwieldy
and out-of-date as soon as it was published.
The range of risks varies from device to device
depending on the technology used, its intended
use and its method of use. For example, dental
hygienists use tools such as scalers and hand
instruments to scrape bacterial deposits from
teeth. Micro-ultrasonic scalers also are avail-
able for the same purpose—removing bacterial
deposits—but use vibration and a pressurized
stream of water. The risks of the simple hand
tool scaler are much different than those of the
micro-ultrasonic scaler.
As technologies evolve, new hazards will be
introduced that may not be foreseen thus, there
is a need for a standardized risk identification,
mitigation and control process.
The general process outlined by ISO 14971
creates a risk management plan to document
how risk management activities will be per-
formed. The next step is risk assessment to
identify potential hazards and estimate the risk
for each situation associated with the potential
hazards. In the example of the scaler hand tool,
the sharp tip presents a potential hazard.
IEC 62366-1 Usability in Medical Devices
As healthcare and technology have progressed
over time, more-complicated medical devices
and device use by less-skilled users, including
patients themselves, have followed suit.21
IEC 62366 was published in 2007 and
amended in 2014, expanding the standard’s
scope to include all medical devices, nonac-
tive implantable medical devices and active
implantable medical devices. More recently, IEC
62366 was revised in 2015 to IEC 62366-1. The
updated standard divides IEC 62366 into two
parts: IEC 62366-1 and IEC/TR 62366-2. The
first part discusses usability engineering princi-
ples and provides an overview of how usability is
incorporated into medical device development.
The second part is a technical report including
guidance on compliance with IEC 62366-1.
This standard addresses the need for usabil-
ity engineering to minimize use errors and
use-associated risks. Similar to other standards
discussed previously, and for similar reasons,
IEC 62366 does not prescribe the specifics of a
medical device user interface, but does describe
the analysis, specification, design, verification,
and validation usability processes related to
device safety. The standard has close ties and
many references to ISO 14971. If designed well,
a manufacturer’s risk management and usabil-
ity processes will dovetail efficiently into each
other. One IEC 62366 appendix includes a dia-
gram mapping the inputs and outputs between
risk management and usability processes.
IEC 62304 Edition 1.1 2015-06 Medical
Device Software—Software Lifecycle
Processes
Software is incorporated into many medical
devices. Just as it is necessary to ensure safe
and effective mechanical and electromechan-
ical devices, devices incorporating software
also must be safe and effective. This standard
was created in the belief that software testing
alone is insufficient to ensure safe operation.
Thus, IEC 62304 provides a framework for safe
software design and maintenance processes
throughout the product lifecycle. It assumes
software activities occur within a QMS and risk
management system, specifically ISO 14971.
This standard includes general requirements
for software development, maintenance, risk
management, configuration management and
problem resolution processes. Similar in nature
to the standards cited above, this standard does
not prescribe what software code should look
like but focuses on the processes to create safe
and effective software.
ISO 14971 is referenced in several of the
standards mentioned above. Sometimes, an SDO
publishes a Technical Report (TR) to guide
a manufacturer or regulatory professional in
applying a certain standard. IEC TR 80002-1—
Medical Device Software—Part 1: Guidance on
the Application of ISO 14971 to Medical Device
Software is one example. This TR is the result of
collaborative work by joint working groups IEC
SC 62A Common Aspects of Electrical Equipment
Used in Medical Practice, IEC 62 Electrical
Equipment in Medical Practice and ISO TC 210
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
Given the wide range of medical devices, from
thermometers to surgical tools, and the technol-
ogies in use, an encyclopedia of hazards and risk
mitigation measures would be large, unwieldy
and out-of-date as soon as it was published.
The range of risks varies from device to device
depending on the technology used, its intended
use and its method of use. For example, dental
hygienists use tools such as scalers and hand
instruments to scrape bacterial deposits from
teeth. Micro-ultrasonic scalers also are avail-
able for the same purpose—removing bacterial
deposits—but use vibration and a pressurized
stream of water. The risks of the simple hand
tool scaler are much different than those of the
micro-ultrasonic scaler.
As technologies evolve, new hazards will be
introduced that may not be foreseen thus, there
is a need for a standardized risk identification,
mitigation and control process.
The general process outlined by ISO 14971
creates a risk management plan to document
how risk management activities will be per-
formed. The next step is risk assessment to
identify potential hazards and estimate the risk
for each situation associated with the potential
hazards. In the example of the scaler hand tool,
the sharp tip presents a potential hazard.
IEC 62366-1 Usability in Medical Devices
As healthcare and technology have progressed
over time, more-complicated medical devices
and device use by less-skilled users, including
patients themselves, have followed suit.21
IEC 62366 was published in 2007 and
amended in 2014, expanding the standard’s
scope to include all medical devices, nonac-
tive implantable medical devices and active
implantable medical devices. More recently, IEC
62366 was revised in 2015 to IEC 62366-1. The
updated standard divides IEC 62366 into two
parts: IEC 62366-1 and IEC/TR 62366-2. The
first part discusses usability engineering princi-
ples and provides an overview of how usability is
incorporated into medical device development.
The second part is a technical report including
guidance on compliance with IEC 62366-1.
This standard addresses the need for usabil-
ity engineering to minimize use errors and
use-associated risks. Similar to other standards
discussed previously, and for similar reasons,
IEC 62366 does not prescribe the specifics of a
medical device user interface, but does describe
the analysis, specification, design, verification,
and validation usability processes related to
device safety. The standard has close ties and
many references to ISO 14971. If designed well,
a manufacturer’s risk management and usabil-
ity processes will dovetail efficiently into each
other. One IEC 62366 appendix includes a dia-
gram mapping the inputs and outputs between
risk management and usability processes.
IEC 62304 Edition 1.1 2015-06 Medical
Device Software—Software Lifecycle
Processes
Software is incorporated into many medical
devices. Just as it is necessary to ensure safe
and effective mechanical and electromechan-
ical devices, devices incorporating software
also must be safe and effective. This standard
was created in the belief that software testing
alone is insufficient to ensure safe operation.
Thus, IEC 62304 provides a framework for safe
software design and maintenance processes
throughout the product lifecycle. It assumes
software activities occur within a QMS and risk
management system, specifically ISO 14971.
This standard includes general requirements
for software development, maintenance, risk
management, configuration management and
problem resolution processes. Similar in nature
to the standards cited above, this standard does
not prescribe what software code should look
like but focuses on the processes to create safe
and effective software.
ISO 14971 is referenced in several of the
standards mentioned above. Sometimes, an SDO
publishes a Technical Report (TR) to guide
a manufacturer or regulatory professional in
applying a certain standard. IEC TR 80002-1—
Medical Device Software—Part 1: Guidance on
the Application of ISO 14971 to Medical Device
Software is one example. This TR is the result of
collaborative work by joint working groups IEC
SC 62A Common Aspects of Electrical Equipment
Used in Medical Practice, IEC 62 Electrical
Equipment in Medical Practice and ISO TC 210