Overview of Standards for
Role of FDA
Charles Ho, Ph.D.
1. Why use standards?
2. FDA’s role in standards
3. List of major standards
4. Limitations of standards
1. Why use standards?
Standards facilitate communications in
Standards provide test protocols with
pass/fail criteria, which form a common
language between manufacturers and
FDA for substantiating claims. No need
to re-invent the wheel each time.
To claim adequate battery capacity to
power a defibrillator
Reference: ANSI/AAMI DF80, clause
Protocol: At O°C, the battery should
enable the defibrillator to deliver at least
20 shocks at the maximum shock energy.
[O°C test is more demanding than room
Standards also facilitate standardization of device
specifications among device manufacturers.
May lead to standardizing certain features, like
pad connections and the user interface.
But need to be in sufficient detail to allow
interpretation by both design engineers and FDA.
Remember, most standards
concerning external defibrillators are
The only mandatory standard for an
external defibrillator is the Performance
Standard for Electrode Lead Wires and
Patient Cables, 21 CFR 898.
2. FDA’s Role in Standards
Although FDA had been involved in the
development and use of medical
device standards for decades, the
Food and Drug Administration
Modernization Act (FDAMA) of 1997
formalized the process.
* Above statement adapted from FDA website.
FDA liaisons attend standard
committee meetings, participate in
discussions and vote on proposed
standards, in order that the
resultant standards may be more
acceptable to both the industry
and the FDA.
Dr. Oscar Tovar is our Primary
Liaison for standards on external
defibrillators at the AAMI DF
Committee and the IEC TC 62/SC
62D/MT 19 Committee.
Dr. Richard Gray is the Alternate
The FDA has only one vote in
each standards committee, just
like any other entity. Thus, some
standards may not be 100%
acceptable to FDA.
In that case, FDA recognizes only
the parts of a standard that FDA
agrees with, and declines to
recognize the parts that FDA does
not agree with.
Recognition of a standard
By recognizing a standard, or
parts of a standard, FDA indicates
that we have reviewed the
standard and found it mostly
acceptable for substantiating
claims made in a premarket
Example: A 510(k) claiming
adequate battery capacity
provides a test report using AAMI
DF80, clause 102.2. And FDA
can review this test very quickly.
If a manufacturer chooses not to comply
with an FDA recognized standard, or
tests a defibrillator using clauses in the
standard that FDA declines to recognize,
FDA will still review the premarket
submittal on a case by case basis.
Consequently, FDA will have to review the
unrecognized clauses in a recognized standard,
or the unfamiliar test protocols in a
unrecognized standard from the ground up.
This may generate a lot of basic questions to
clarify terms or rationale for a certain test
protocol, usually resulting in more work for both
the manufacturer and FDA.
3. List of Major Standards for
ANSI/AAMI DF80: Medical electrical equipment
- Part 2-4: Particular requirements for the safety
of cardiac defibrillators (including automated
-- the most commonly used standard in submittals
on external defibrillators
-- covers most hardware safety and effectiveness
specifications, except waveform effectiveness
IEC 60601-2-4: Medical electrical equipment -
Part 2-4: Particular requirements for the safety
of cardiac defibrillators and cardiac defibrillator-
For general safety:
IEC 60601-1: Medical Electrical
Equipment - Part 1: General
Requirements For Safety 1: Collateral
Standard: Safety Requirements for
Medical Electrical Systems
For electromagnetic compatibility (EMC):
IEC 60601 -1-2: Medical Electrical
Equipment - PART 1: General
Requirements For Safety 2. Collateral
Standard: Electromagnetic Compatibility -
Requirements and Tests
[for defibrillator electrodes (pads or
ISO 10993 – 5: Biological evaluation
of medical devices -- Part 5: Tests for
in vitro cytotoxicity
ISO 10993-10 Biological evaluation of
medical devices — Part 10: Tests for
irritation and delayed-type
IEC 60068-2-27: Environmental testing -
Part 2-27: Tests - Test Ea and guidance:
IEC 60068-2-6: Environmental testing -
Part 2: Tests - Test Fc: Vibration
IEC 60529 Degrees of protection
provided by enclosures (IP Code).
[protection against rain and dust]
For sample list of standards, see handout.
4. Limitations of standards
Standards do not cover every aspect of
the external defibrillator. For example,
there is no clinical or animal study
protocol in the AAMI DF80 standard.
(However, an informative annex DD in
DF80 has some historical notes on
Further, it is widely accepted that
biphasic waveforms are superior to
monophasic waveforms and result in
improved patient survival. But the
standard that covers basic safety and
effectiveness requirements, AAMI
DF80, does not prohibit monophasic
A new defibrillator with this old
technology can still claim compliance
Lastly, some standards permit a large
leeway in designing the defibrillator,
so that performance could vary
considerably from manufacturer to
An example is the difference between
delivered energy and selected energy
in a defibrillator.
[From DF80, clause 2.12.101]
= shock energy actually delivered to a patient
[From clause 2.12.106]
= energy intended to be delivered, as
determined by the setting of a control
Usually, this is the energy shown in the energy
dial of the defibrillator front panel.
However, the selected energy is
specified for the 50 ohm load only. For
all other loads, the manufacturer just
has to specify the selected energies in
the device manual.
Additionally, the verification test
protocol allows a ± 15% tolerance in
testing the measured delivered energy
against the specified selected energy.
[clauses 6.3 aa, 6.8.3 aa and 50.2]
These two layers of tolerance
combine to allow delivered energy
values that may be very different
from the selected energies on the
energy dial, for loads other than
50 ohm. Yet not every patient is a
50 ohm load to the defibrillator.
Still compliant with DF80!
This presentation has briefly described
FDA’s use of standards for external
defibrillators, and the standards’
limitations. It is hoped that everyone
can keep these in mind as we move
forward in this field.