IEC 60601-1-11 is a mandatory standard provision geared toward determining and documenting failure and hazard potential of medical electrical equipment intended for home use. By addressing the challenges associated with regulating the use of medical devices in the home, we've identified key performance requirements that must be considered when designing a medical device for use outside of the traditional clinical environment.

1. Home Healthcare
IEC 60601-1-11
October 24, 2013
Michael Brousseau Safety Manager
Brousseau,
1
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2. Part 1
2
Background
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3. Background: Size & Scope
Fast Facts
F tF t
12 Million Americans Receive Home Care
75 Million Americans by 2030
$74.3 Billion Annual Expenditure 2011 (CMS)
3% Annual Health Care Expenditure 2011
75% Receive Skilled Nursing Care in part by a caretaker or self
Majority are >65 years
44 Million are caregivers of someone >18
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4. Background: The Drivers
Overall Spending
2011: $2.7 Trillion
(projected growth)
2020: $4.6 Trillion
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5. Background: The Drivers
Per Capita Expenditure Per Person
2011: $8,680
(projected growth)
2020: $13 708
$13,708
The US spends $2,800+ more per person than the
second highest spender among developed countries
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6. Background: The Drivers
U.S. Spends More Money on Health Care Per Capita as a %GDP than Any
Country in the World
Obesity
400M
Aging
600M
Chronic
Disease
860M
Non Compliance
300B
U.S. Healthcare System Ranks 37th out of 191 Countries
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7. Background: The Drivers
Aging Population
65 & Older
Will increase from
40 million in 2010
to
88 million in 2050
Medical Technology
7
Chronic Disease
$2.025 Trillion 2011
$3 out of every $4 health
care d ll
dollars
1 out of every 2
Americans
Remote Monitoring &
Telemedicine
Hospital
Readmissions
R d i i
$26 B in 2011
($17 B Preventable)
Nearly 1 in 5 patients
readmitted within 30 days
Seeking cost-effective
delivery of care
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8. Background: FDA Definition
Device intended for users in a non-clinical or transitory environment
Managed partl or wholly b the user
partly
holl by
ser
May require training for the user by a healthcare professional in
order to be used safely and effectively.
Includes
I l d permanently and t
tl
d temporarily i l t d d i
il implanted devices
Any type of equipment that a person may use to recover and rehabilitate
Must be capable of safely accommodating the many needs of
the person using it.
“Home Use Extends Beyond the Home”
Home
Home
Encompass all environments in which a person plans to
use his or her medical device in day-to-day life.
Delivers Medical Care Anywhere and Everywhere
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9. Background: US vs. EU
Major
M j variances
i
exist between
United States
and Europe
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10. Background: US vs. EU
USA
• U.S. Nursing Homes are considered
S
professional environments and products are
classified as Class 1
EU
• Europe Nursing Homes are considered a
p
g
home environment and products are
classified as Class 2
 Class One Rely on a Ground,
y
g
 Class Two Do not rely on a ground
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11. Part 2
11
Challenge & Opportunity
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12. From 1997 through 2009, FDA received over 19,000
reports of adverse events in which the reporter listed the
location where the incident took place as “home.”
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13. Hospital vs. Home
The Home environment is fundamentally different from the clinical
environment. These unique challenges have the potential to impact
patient safety:
• Caretaker Knowledge
• Device Usability
• Environmental Predictability
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14. Challenges: Environmental Issues
Power
Sources
Children
Location
Temperature
& Humidity
Sanitation
EMI
Pets &
Vermin
Public
Emergencies
Noise
Air
Quality
Water
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15. Challenges: Environmental Issues
Presence of Ho sehold Pets
Household Pets:
Case Example: A patient was put on peritoneal dialysis because
of her failing kidneys. She lived in a one bedroom apartment with
g
y
p
her cat. Although the patient kept the cat out of her bedroom while
she was undergoing dialysis, there was cat fur and dander
throughout the room. Cat fur got into the patient’s dialysis tubing
and entered her peritoneum and she contracted peritonitis
peritoneum,
peritonitis.
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16. Challenges: Environmental Issues
Electromagnetic Interference:
Interference
Case Example: An individual with an implantable cardioverter
defibrillator (ICD) was playing electric g
(
)
p y g
guitar at home. As he was
unplugging the guitar from the amplifier, feedback from the
amplifier caused the individual to feel a painful vibration at the site
of his ICD. His left arm became immobile for almost two minutes.
The painful sensation stopped when his wife unplugged the
amplifier.
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17. Challenges: Environmental Issues
Noise Levels:
Le els
Case Example: A pediatric patient was receiving ventilator
py
,
g
therapy in the home, and the ventilator tubing became
disconnected. The patient’s mother was asleep and did not hear
the ventilator alarm. There were other ambient noises in the home
(e.g., television), and they may have interfered with the mother’s
ability to hear the alarm The patient died
alarm.
died.
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18. Challenges: User Issues
OffLabel
Use
Lifestyle
Physical
Capabilities
Durability
Education
Level
Ease of
Use
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Availability
of
Instructions
Emotional
Stability
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19. Challenges: User Issues
Physical Capabilities
Ph sical Capabilities:
Case Example: A patient doing home nocturnal dialysis was
found by her husband, unresponsive. She was disconnected from
y
,
p
the dialysis machine and her tubing was in a closed circuit filled
with saline. There was a syringe attached to one of her lines, but
the other line was open, and the patient had lost a significant
amount of blood It appeared that she had been unable to clamp
blood.
her catheter by herself. The patient died due to blood loss.
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20. Part 3
20
The Standard
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21. The Standard: National Deviations
“Medical Electrical Equipment – Part 1: General Requirements for
Medical
Basic Safety and Essential Performance – Collateral Standard:
Requirements for Medical Electrical Equipment and Medical
Electrical Systems Used in the Home Healthcare Environment”
Environment
ANSI/AAMI HA60601-1-11: 2011 – US Deviations
CAN/CSA-C22.2 No. 60601-1-11: 2011
CENELEC EN 60601-1-11: 2010
IEC 60601-1-11: 2010
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22. Clause 4.1 – Mains Supply for ME Equipment
and ME Systems
Non-life-supporting Medical Electrical Equipment or Medical Electrical Systems
- Testing completed at 110% and 85% of rating voltage or voltage range
Life-supporting Medical Electrical Equipment or Medical Electrical Systems
- Testing completed at 110% and 80% of rating voltage or voltage range
g
p
g
g
g
g
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23. Clause 4.2.1 – Environmental Conditions of
Transport and Storage between Uses
Unless otherwise indicated in the IFU or if the Medical Electrical Equipment is
stationary, the equipment shall comply t th f ll i t
t ti
th
i
t h ll
l to the following transport and storage
t d t
conditions
-25°C without relative humidity control; and
70°C at a relative humidity up to 93% non-condensing
If the IFU states a more restricted range, justification is provided as part of the
range j stification pro ided
Usability Engineering File which appears in the Risk Management File; and
The range is marked on the product and the product’s carrying case
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24. Clause 4.2.1 Test Conditions
a) Prepare equipment for transport or storage per the IFU
b) Expose equipment at lowest environmental conditions for 24 hrs or till
thermal stability is reached (minimum 2 hrs)
c) Expose equipment at highest environmental conditions for 24 hrs or till
thermal stability is reached (minimum 2 hrs)
d) Allo eq ipment to stabili e back to operating conditions of normal use
Allow equipment stabilize
se
e) Evaluate equipment against its specifications, Basic Safety, and Essential
Performance characteristics
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25. Clause 4.2.1 – Environmental Operating
Conditions
Unless otherwise indicated in the IFU or if the Medical Electrical Equipment is
stationary, the equipment shall comply t th f ll i t
t ti
th
i
t h ll
l to the following transport and storage
t d t
conditions
At
temperature range of 5°C t 40°C
t
f
to 40°C;
A relative humidity range of 15% to 93%, non-condensing; and
An atmospheric p
p
pressure range of 700 hPa to 1060 hPa
g
If the IFU states a more restricted range, justification is provided as part of the
Usability Engineering File which appears in the Risk Management File; and
y g
g
pp
g
The range is marked on the product and the product’s carrying case
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26. Clause 4.2.2 – Test Conditions
a) Expose equipment to ambient conditions for 6 hrs or till thermal stability
(minimum 2 hrs)
b) Evaluate equipment against its specifications, Basic Safety, and Essential
Performance characteristics
c) Evaluate equipment against its specifications, Basic Safety, and Essential
Performance characteristics at lowest specified atmospheric p
p
p
pressure
d) Evaluate equipment against its specifications, Basic Safety, and Essential
Performance characteristics at highest specified atmospheric pressure
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27. Clause 4.2.2 – Test Conditions, cont’d
e) Cool equipment to lowest specified environmental operating conditions for 6
hrs or till thermal stability (minimum 2 hrs)
f) Evaluate equipment against its specifications, Basic Safety, and Essential
Performance characteristics
g) Warm equipment to highest specified environmental operating conditions for
6 hrs or thermal stability (minimum 2 hrs)
y(
)
h) Evaluate equipment against its specifications, Basic Safety, and Essential
Performance characteristics
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28. Clause 4.2.3 – Environmental Shock to TransitOperable ME Equipment
a) Set up equipment for operation according to intended use
b) Expose equipment to lowest specified environmental operating conditions for
6 hrs or thermal stability (2 hrs)
c) Within 5 minutes, expose equipment to highest specified operating
conditions
d) While maintaining step c) evaluate equipment against its specifications,
Basic Safety, and Essential Performance characteristics until thermal
y,
stability or for 2 hrs
Repeat test new sample allowed by reversing steps b) and c)
test,
allowed,
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29. Clause 5 – General Requirements for Testing
ME Equipment
In addition to the requirements of clause 5.9.2.1 of the general standard,
accessibility also determined by:
Small Finger Probe – in a bent or straight position
a)
)
For all positions of equipment when operated in normal use
p
q p
p
b)
After opening access covers and removal of parts
i)
ii)
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Opened without use of tool
IFU states Lay Operator is to open access cover
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30. Clause 6 – Classification of ME Equipment and
ME Systems
Unless equipment in the Home Healthcare Environment is to be permanently
installed, the equipment shall be:
Class II or Internally Powered;
Shall not have a Functional Earth Terminal; and
Applied Parts, shall be Type BF or Type CF
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31. Clause 7.1 – Usability of Accompanying
Documents
Usability of the identification, marking, and accompanying documents intended
for L Operator or Lay Responsible O
f Lay O
t
L R
ibl Organization shall b evaluated against
i ti
h ll be
l t d
i t
the Operator Profile assuming a maximum of eight years education.
Equipment in the Home Healthcare Environment should be designed to be
simple to use and not require reference to complex Accompanying Documents.
Equipment in the Home Healthcare Environment should be designed to be
q p
g
simple to use and to minimize, reference to Accompanying Documents.
Verified by inspection of the Usability Engineering Process/File
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32. Clause 7.2 – Additional Requirements for
Marking IP Classification
For the following types of products, an IP rating is required:
a) Body-worn
b) Hand-held
c) Mobile
d) Portable
If a carrying case provides the protection against ingress of liquids, then it shall
be marked but
marked, but…
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33. Clause 7.2 – Additional Requirements for
Marking IP Classification
If the enclosure does not provide the minimum protection against ingress of
water, it shall b marked:
t
h ll be
k d
KEEP DRY”
“KEEP DRY
Or
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34. Clause 7.3.1 – Contact Information
The IFU shall include the following:
a)
)
for
f assistance, if needed, i setting up, using, or maintaining th product
i t
d d in tti
i
i t i i the
d t
b)
to report unexpected operation or events
A postal address and either a phone number or web address to contact the
Manufacturer or Manufacturer’s Representative
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35. Clause 7.3.2 – Lay Operator Briefing Information
IFU shall include information for the Healthcare Professional to
brief Lay Operator or Lay Responsible Organization on any
known contraindications to the equipment and precautions to
be taken including the following:
•
•
•
Information on medicinal substances or human blood
derivatives
•
35
Changes in performance of equipment
Measuring function accuracies
Exposure to reasonably foreseeable environmental
conditions
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36. Clause 7.4.1 – Additional Requirements for
Warning and Safety Notices
For each warning and safety sign, the IFU shall:
-D
Describe th nature of th h
ib the t
f the hazard;
d
- Consequences that could occur from not following advice; and
- Precautions for reducing risk
g
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37. Clause 7.4.1 – Additional Requirements for
Warning and Safety Notices
The IFU shall, at least, address the following:
- St
Strangulation d t cables and h
l ti due to bl
d hoses
- Small parts being inhaled or swallowed
- Allergic reactions to accessible materials
g
- Contact injuries
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38. Clause 7.4.1 – Additional Requirements for
Warning and Safety Notices
The IFU shall include warnings that it is unsafe to:
- U accessories not d
Use
i
t described i th IFU
ib d in the
- Interconnect equipment to other equipment not described in the IFU
- Modify the equipment
y
q p
- Use equipment outside of the carrying case, if the case provides a
degree of protection
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39. Clause 7.4.2 – Additional Requirements for an
Electrical Power Source
If Basic Safety and Essential Performance is dependent on an Internal Electrical
Power Source, the IFU shall describe the following:
- Typical operation time or number of procedures
- Typical service life
- For a Rechargeable Internal Electrical Power Source, the behavior of
the equipment while charging
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40. Clause 7.4.3 – Additional Requirements for ME
Equipment Description
The IFU shall include easily understood (effective):
• diagrams,
• illustrations, or
• photographs
h t
h
of a fully assembled, ready to operate equipment including:
• controls,
• visual information signals, and
• indicators
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41. Clause 7.4.4 – Additional Requirements for ME
Equipment Start-up Procedure
The IFU shall include easily understood (effective):
• diagrams,
• illustrations, or
• photographs
of the proper connection of the Patient to the equipment, accessories or other
equipment.
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42. Clause 7.4.4 – Additional Requirements for ME
Equipment Start-up Procedure
The IFU shall include the time from switching “ON” until the equipment is ready
for Normal Use, if the time is greater than 15 seconds
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43. Clause 7.4.5 – Additional Requirements for
Operating Instructions
The IFU shall include information on conditions in the Home Healthcare
Environment th t can affect Basic Safety and Essential Performance including:
E i
t that
ff t B i S f t
dE
ti l P f
i l di
- Effects of lint, dust, or light
- Devices or sources that could cause interference problems
- Effects of degraded sensors and electrodes
- Effects of pets, pests, and children
Information shall include steps the Lay Operator can take to identify and
resolves these issues.
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44. Clause 7.4.5 – Additional Requirements for
Operating Instructions
The IFU shall explain the meaning of the IP rating that appears on either:
- Th equipment, or
The
i
t
- The equipment’s carrying case
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45. Clause 7.4.6 – Additional Requirements for ME
Equipment Messages
The IFU shall include a troubleshooting guide for malfunctions during start-up
and operation.
The troubleshooting guide shall disclose the necessary steps to be taken for an
alarm condition.
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46. Clause 7.4.7 – Additional Requirements for
Cleaning, Disinfection and Sterilization
The IFU shall indicate, for equipment, parts, or accessories, the frequency of:
- cleaning,
- cleaning and disinfection, or
- cleaning and sterilization
l
i
d t ili ti
The IFU shall also include the following methods for:
- drying,
y g,
- handling, and
- storage between uses
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47. Clause 7.4.7 – Additional Requirements for
Cleaning, Disinfection and Sterilization
These instructions shall cover either:
- single patient,
- multiple patients, or
lti l
ti t
- indicate that professional hygienic maintenance prior to re-use is
required (including contact information for the service)
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48. Clause 7.4.8 – Additional Requirements for
Maintenance
The IFU shall include the following information:
- Expected Service Life of the Medical Electrical Equipment
-E
Expected Service Lif of accessories, shipped with M di l El t i l
t d S i Life f
i
hi
d ith Medical Electrical
Equipment
- If the Shelf Life is less than the Expected Service Life, the Shelf Life
of accessories shipped with the Medical Electrical Eq ipment
accessories,
ith
Equipment
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49. Clause 7.4.9 – Additional Requirements for
Environmental Protection
The IFU shall include information on:
- proper di
disposal of th M di l El t i l E i
l f the Medical Electrical Equipment, parts, or
t
t
accessories and
- a statement that the Lay Responsible Organization shall contact local
authorities
a thorities for the disposal of potentiall bio ha ardo s parts and
potentially bio-hazardous
accessories
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50. Clause 7.4.10 – Additional Requirements for ME
Equipment and ME Systems
For equipment that incorporates the use of a Distributed Alarm System, the IFU
shall state the recommended placement of the remote part of the Distributed
Alarm System to ensure the operator is notified at all times.
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51. Clause 7.5.1 – Permanently Installed Class I
Equipment
For Permanently Installed Class I Equipment, the Technical Description shall
include:
i l d
- Warning that connection of Protection Earth is completed by a
qualified Service Personnel
- Specifications for the Protective Earth Conductor
- Warning to verify the integrit of the e ternal protecti e earthing
erif
integrity
external protective
system
- Warning to connect and verify the Protective Earth Terminal is
connected to the external protective earth system
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52. Clause 7.5.2 – Additional Requirements for
Professional Hygienic Maintenance
If equipment requires profession hygienic maintenance prior to re-use
The T h i l D
Th Technical Description i l d cleaning and di i f ti or cleaning and
i ti include l
i
d disinfection
l
i
d
sterilization:
- before and after any servicing
- when equipment is transferred to another patient
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53. Clause 7.5.2 – Additional Requirements for Cleaning
& Disinfection of ME Equipment and ME Systems
Cleaning and disinfection procedures for equipment in the Home Healthcare
Environment shall b capable of b i preformed b a L O
E i
t h ll be
bl f being
f
d by Lay Operator.
t
The Usability of these processes shall be documented in the Usability
Engineering File
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54. Clause 8.2 – Additional Requirements for
Sterilization of ME Equipment and ME Systems
Sterilization procedures for equipment in the Home Healthcare Environment
shall b capable of b i preformed b a L O
h ll be
bl f being
f
d by Lay Operator.
t
The Usability of this process shall be documented in the Usability Engineering
File
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55. Clause 8.3.1 – Ingress of Water or Particulate
Matter into ME Equipment
An IP Rating of IP22 shall be provided for the following equipment:
a)
)
Transit-operable, H d h ld equipment
T
it
bl Hand-held
i
t
b)
Body-worn equipment
All other Transportable Equipment shall be provided with an IP Rating of IP21
If carrying case provides the protection, then the case shall be marked.
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56. Clause 8.3.2 – Ingress of Water or Particulate
Matter into ME Equipment
Enclosures of non-ME Equipment shall also provide a degree of protection
against harmful ingress of water or particulate matter in accordance with there
relevant end of product standards
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57. Clause 8.4 – Additional Requirements for Interruption of
the Power Supply / Supply Mains to ME Equipment and
ME Systems
Life-supporting ME Equipment or ME Systems shall maintain Essential
Performance for a sufficient time or number of procedures, to allow for alternate
P f
f
ffi i t ti
b
f
d
t ll
f
lt
t
methods to be employed, after failure of the supply mains.
The following types of devices can be utilized for maintaining Essential
Performance:
- Internal Electrical Power Source or
- An independent means
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58. Clause 8.4 – Additional Requirements for Interruption of
the Power Supply / Supply Mains to ME Equipment and
ME Systems
The IFU shall disclose the time or number of procedures available following the
failure of electrical power system
The IFU shall describe the alternate means of life support employed
The Technical Description shall describe methods that can employed for a
longer period of time
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59. Clause 8.4 – Additional Requirements for Interruption of
the Power Supply / Supply Mains to ME Equipment and
ME Systems
If a Internal Electrical Power Source is not used, the equipment shall be
provided with an alarm system i l di an medium priority alarm f power
id d ith
l
t
including
di
i it l
for
supply failure.
If the equipment incorporates an Internal Electrical Power Source automatic
switch over shall occur in the case of power supply failure.
The equipment shall be provided with an alarm system including an low priority
alarm for the automatic switchover.
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60. Clause 8.4 – Additional Requirements for Interruption of
the Power Supply / Supply Mains to ME Equipment and
ME Systems
The equipment shall be provided with an alarm system including a medium
priority t h i l alarm i di ti th I t
i it technical l
indicating the Internal El t i l P
l Electrical Power S
Source i nearing
is
i
insufficient remaining power to keep the equipment functional.
The technical alarm shall provide the Lay Operator sufficient time or number of
procedures to act.
A low priority technical alarm shall remain on until the Internal Electrical Power
Source is returned above the alarm limit.
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61. Clause 9 – Accuracy of Controls & Instruments
and Protection against Hazardous Outputs
The following, at a minimum, shall be considered as part of the Usability
Engineering P
E i
i Process and Fil
d File:
Changes of
Controls
Confusion in
Operation Modes
Unexpected
Movement
Transfer of
Energy /
Substances
Potential of
Disconnection
Exposure to
Biological
Materials
Improper / Unsafe
Operation
Parts Inhaled /
Swallowed
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62. Clause 10.1.1 – General Requirements for
Mechanical Strength – Table 1
Non-Transit-operable and Hand-Held
• Push, Drop, Molding Stress Relief, Shock, and Vibration
Non-Transit-operable and Body-worn
• Push, Impact, Drop, Molding Stress Relief, Shock, and Vibration
Non-Transit-operable and Portable
• Push, Impact, Drop, Molding Stress Relief, Shock, and Vibration
Non-Transit-operable and Mobile
• Push, Impact, Drop, Rough Handling, Molding Stress Relief, Shock, and
Vibration
Fixed or Stationary
• Push, Impact, and Molding Stress Relief
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63. Clause 10.1.1 – General Requirements for
Mechanical Strength – Table 2
Transit-operable and Hand-Held
•P h D
Push, Drop, M ldi S
Molding Stress R li f Sh k and Vib i
Relief, Shock, d Vibration
Transit-operable and Body-worn
• Push, Impact, Drop, Molding Stress Relief, Shock, and Vibration
Transit-operable and Portable
• Push, Molding Stress Relief, Free Fall, Shock, and Vibration
Transit-operable and Mobile
• Push, Impact, Rough Handling, Molding Stress Relief, Free Fall,
Shock, and Vibration
Shock
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64. Clause 10.1.2 – Requirements for Mechanical
Strength for Non-Transit-Operable ME Equipment
a) Shock Test in accordance IEC 60068-2-27: 2008
- Three shocks per direction per axis (18 total)
b) Broad-band Random Vibration Test in accordance with
IEC 60068-2-64: 2008
- 30 minutes per perpendicular axis
c) Verify that Basic Safety and Essential Performance are maintained
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65. Clause 10.1.3 – Requirements for Mechanical
Strength for Transit-Operable ME Equipment
For Body-worn Equipment
a) Shock Test in accordance with IEC 60068-2-27: 2008
- Either Type 1 or Type 2, three shocks per direction per axis
2
b) Broad-band Random Vibration Test in accordance with IEC 60068-2-64:
2008
- 30 min per perpendicular axis (three total)
c) Verify that Basic Safety and Essential Performance are maintained
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66. Clause 10.1.3 – Requirements for Mechanical
Strength for Transit-Operable ME Equipment
For Hand-Held Equipment
a) Shock Test in accordance with IEC 60068-2-27: 2008
- Eith T
Either Type 1 or T
Type 2 th
2, three shocks per di ti per axis
h k
direction
i
b) Broad-band Random Vibration Test in accordance with IEC 60068-2-64:
)
2008
- 30 min per perpendicular axis (three total)
c) Verify that Basic Safety and Essential Performance are maintained
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67. Clause 10.1.3 – Requirements for Mechanical
Strength for Transit-Operable ME Equipment
For Portable and Mobile Equipment
a) Shock Test in accordance with IEC 60068-2-27: 2008
- Either Type 1 or Type 2, three shocks per direction per axis
b) Broad-band Random Vibration Test in accordance with IEC 60068-2-64:
2008
- 30 min per perpendic lar a is (three total)
perpendicular axis
c) Free Fall Test in accordance with IEC 60068-2-31: 2008
- Procedure 1, two falls in each specified altitude
p
d) Verify that Basic Safety and Essential Performance are maintained
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68. Clause 10.2 – Additional Requirements for
Internal Electrical Power Sources
If a Internal Electrical Power Source is essential to maintain Basic Safety,
Essential P f
E
ti l Performance, or control risks f
t l i k from loss of Essential P f
l
fE
ti l Performance it
shall be provided with one of the following means of indication:
- Number of procedures remaining
- Remaining operating time
- Percentage of remaining operating time or energy
- a “f el” ga ge
“fuel” gauge
This means may be indicated continuously or by operator action.
The IFU shall state how to determine the state of the Internal Electrical Power
Source
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69. Clause 10.3 – Additional Requirements for
Actuating Parts of ME Equipment
Control of Medical Electrical Equipment that can affect Basic Safety or Essential
Performance shall b protected f
P f
h ll be
t t d from accidental or unauthorized adjustment
id t l
th i d dj t
t
- Access controlled by tool
- Access controlled by Responsible Organization password
- Access controlled by Operator password
- Access controlled by fingerprints
Operator-adjustable controls for calibration shall include means to prevent
unintentional changes
g
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70. Clause 11 – Protection Against Strangulation or
Asphyxiation
Means shall be provided to control the risk of strangulation or asphyxiation of the
patient and others
ti t d th
- By routing of wirings/tubing
- By retention devices
- Multiple length accessories
- Not providing removable small pieces
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71. Clause 12.1 – Emissions Classification
Medical Electrical Equipment and Medical Electrical Systems in the Home
Healthcare Environment shall be classified as Class B according to CISPR 11:
2009
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72. Clause 12.2 – Protection of the Public Mains
Network
For Home Healthcare Equipment the Public Mains Network requirements of
Clause 6.1.3 of IEC 60601-1-2: 2007 apply
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73. Clause 12.3 – Additional Technical Description
Requirements Applicable to ME Equipment & ME Systems
The IFU shall have a statement that the equipment is to be installed and put into
service according t th i f
i
di to the information i th accompanying d
ti in the
i documents
t
The IFU shall have a statement that wireless communication equipment can
affect the equipment and should be kept at least a distance of “d” away from the
equipment.
“d” is calculated by the manufacturer from 800 MHz to 2.5 GHz using Tables 5
y
g
and 6 of IEC 60601-1-2: 2007
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74. Clause 12.5 – Additional Requirements for
Electrostatic Discharge (ESD) Tests
The standard test finger of the general standard (Figure 6) is used to determine
accessible parts d i th ESD t t
ibl
t during the
test
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75. Clause 13.1 – Additional Requirements for
Generation of Alarm Signals
Each High and Medium Priority Alarm provided in the Home Healthcare
Equipment shall cause th generation of an audio alarm
E i
t h ll
the
ti
f
di l
Exception – Unless connected to a Distributed Alarm System that includes
the generation of auditory alarm signals
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76. Clause 13.2 – Additional Requirements for of
Alarm Signal Volume
If the Home Healthcare Equipment is capable of setting the volume below audio
levels th equipment shall:
l
l the
i
t h ll
ALARM OFF
AUDIO OFF
- Activate the indication of “ALARM OFF” or “AUDIO OFF” per IEC
60601-1-8
- For Life-supporting Medical Electrical Equipment not be possible
unless connected to a Distributed Alarm System capable of g
y
p
generating
g
Auditory Alarm Signals
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77. Part 4
77
Why do products fail?
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78. Why do products fail?
Manuals
Markings
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79. Want More?
Download the audio recording to accompany these slides
www.intertek.com/medical/events/home-healthcare-webinar
If you have questions about a specific device that you are
looking to bring to new markets, contact us directly.
icenter@intertek.com
79
1-800-WORLDLAB
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