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Global Medical Device Regulatory Strategy
environmental health and sustainability.9
Standard UL 60601-1 Medical Electrical
Equipment, Part 1: General Requirements for
Safety references 36 additional UL standards
that may be used in lieu of IEC 60601-1 if the
differences in the two documents’ particular
requirements are recognized and understood for
effective implementation in a global regulatory
strategy. It is important to note, however, many
UL standards are not recognized by regulatory
authorities outside the US.
Institute of Electrical and Electronics
Engineers (IEEE): Other professional organiza-
tions’ work includes coordinating and publishing
technical standards or models the medical device
industry may utilize. IEEE is a professional
association dedicated to advancing technolog-
ical innovation. IEEE, among other services,
publishes engineering technical standards and
models. Medical device software engineering
professionals and software medical device and
mobile medical app (MMA) manufacturers
continue to draw from well-established IEEE
standards, such as IEEE 1012-2012 Standard for
System and Software Verification and Validation.
Association for the Advancement of
Medical Instrumentation (AAMI): AAMI
is a nonprofit organization founded in 1967
supporting the healthcare community in devel-
oping, managing and using safe and effective
medical technology. AAMI’s standards program
consists of more than 100 technical committees
and working groups that produce standards,
recommended practices and technical informa-
tion reports for medical devices. Standards and
recommended practices represent a national
consensus and many have been approved by
ANSI as American National Standards. AAMI
also administers a number of international ISO
and IEC technical committees as well as US
TAGs.10 An example of an AAMI standard
is AAMI ANSI HE75:2009(2013) Human
Factors Engineering—Design of Medical Devices.
National Electrical Manufacturers
Association (NEMA): NEMA represents
nearly 325 electrical equipment and medi-
cal imaging manufacturers that make safe,
reliable and efficient products and systems
serving seven major markets. For standards for
medical imaging, the Medical Imaging and
Technology Alliance (MITA) plays key roles.
MITA, a division of NEMA, is the organization
for medical imaging equipment, radiopharma-
ceutical manufacturers, innovators and product
developers. MITA is the Secretariat of Digital
Imaging and Communications in Medicine
(DICOM). MITA technologies include com-
puter tomography (CT) scanners, nuclear
imaging, radiopharmaceuticals, magnetic res-
onance imaging (MRI), imaging information
systems, ultrasound and medical X-ray equip-
ment. Examples of standards include NEMA
XR 26-2012 Access Controls for Computed
Tomography—Identification, Interlocks and
Logs and NEMA MS-10-2010 Determination
of Local Specific Absorption Rate (SAR) in
Diagnostic Magnetic Resonance Imaging (MRI).
Other areas NEMA covers, in addition to med-
ical imaging, include building systems, building
infrastructure, lighting systems, industrial prod-
ucts and systems, utility products and systems,
transportation systems and manufacturers and
installers of durable medical equipment.
ASTM International: Formally known as
the American Society for Testing and Materials,
ASTM International currently has more than
7,000 standards that have been adopted as the
basis of national standards or referenced in reg-
ulations around the world in a wide variety of
industries. These technical standards are used
in product development, product testing and
quality systems.11 Examples of standards include
ASTM F2516-07 Standard Test Method for
Tension Testing of Nickel-Titanium Superelastic
Materials and ASTM F1980-07(2011) Standard
Guide for Accelerated Aging of Sterile Barrier
Systems for Medical Devices.
Additional Related Organization
As noted earlier, IMDRF is the successor to the
Global Harmonization Task Force (GHTF).
IMDRF is not an SDO but is an international
group of volunteers representing medical
device regulatory authorities from Europe, the
US, Canada, Japan and Australia who develop
medical device and IVD guidance documents.
The Asian Harmonization Working Party
(AHWP),12 ISO and IEC joined IMDRF as
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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
environmental health and sustainability.9
Standard UL 60601-1 Medical Electrical
Equipment, Part 1: General Requirements for
Safety references 36 additional UL standards
that may be used in lieu of IEC 60601-1 if the
differences in the two documents’ particular
requirements are recognized and understood for
effective implementation in a global regulatory
strategy. It is important to note, however, many
UL standards are not recognized by regulatory
authorities outside the US.
Institute of Electrical and Electronics
Engineers (IEEE): Other professional organiza-
tions’ work includes coordinating and publishing
technical standards or models the medical device
industry may utilize. IEEE is a professional
association dedicated to advancing technolog-
ical innovation. IEEE, among other services,
publishes engineering technical standards and
models. Medical device software engineering
professionals and software medical device and
mobile medical app (MMA) manufacturers
continue to draw from well-established IEEE
standards, such as IEEE 1012-2012 Standard for
System and Software Verification and Validation.
Association for the Advancement of
Medical Instrumentation (AAMI): AAMI
is a nonprofit organization founded in 1967
supporting the healthcare community in devel-
oping, managing and using safe and effective
medical technology. AAMI’s standards program
consists of more than 100 technical committees
and working groups that produce standards,
recommended practices and technical informa-
tion reports for medical devices. Standards and
recommended practices represent a national
consensus and many have been approved by
ANSI as American National Standards. AAMI
also administers a number of international ISO
and IEC technical committees as well as US
TAGs.10 An example of an AAMI standard
is AAMI ANSI HE75:2009(2013) Human
Factors Engineering—Design of Medical Devices.
National Electrical Manufacturers
Association (NEMA): NEMA represents
nearly 325 electrical equipment and medi-
cal imaging manufacturers that make safe,
reliable and efficient products and systems
serving seven major markets. For standards for
medical imaging, the Medical Imaging and
Technology Alliance (MITA) plays key roles.
MITA, a division of NEMA, is the organization
for medical imaging equipment, radiopharma-
ceutical manufacturers, innovators and product
developers. MITA is the Secretariat of Digital
Imaging and Communications in Medicine
(DICOM). MITA technologies include com-
puter tomography (CT) scanners, nuclear
imaging, radiopharmaceuticals, magnetic res-
onance imaging (MRI), imaging information
systems, ultrasound and medical X-ray equip-
ment. Examples of standards include NEMA
XR 26-2012 Access Controls for Computed
Tomography—Identification, Interlocks and
Logs and NEMA MS-10-2010 Determination
of Local Specific Absorption Rate (SAR) in
Diagnostic Magnetic Resonance Imaging (MRI).
Other areas NEMA covers, in addition to med-
ical imaging, include building systems, building
infrastructure, lighting systems, industrial prod-
ucts and systems, utility products and systems,
transportation systems and manufacturers and
installers of durable medical equipment.
ASTM International: Formally known as
the American Society for Testing and Materials,
ASTM International currently has more than
7,000 standards that have been adopted as the
basis of national standards or referenced in reg-
ulations around the world in a wide variety of
industries. These technical standards are used
in product development, product testing and
quality systems.11 Examples of standards include
ASTM F2516-07 Standard Test Method for
Tension Testing of Nickel-Titanium Superelastic
Materials and ASTM F1980-07(2011) Standard
Guide for Accelerated Aging of Sterile Barrier
Systems for Medical Devices.
Additional Related Organization
As noted earlier, IMDRF is the successor to the
Global Harmonization Task Force (GHTF).
IMDRF is not an SDO but is an international
group of volunteers representing medical
device regulatory authorities from Europe, the
US, Canada, Japan and Australia who develop
medical device and IVD guidance documents.
The Asian Harmonization Working Party
(AHWP),12 ISO and IEC joined IMDRF as