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1byone TMB-1585 User Manual

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Type: User Manual
Category: Blood Pressure Monitor
Pages: 14
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User Manual

Arm Blood Pressure Meter

Arm Type

Thank you very much for selecting 1byone Arm Blood Pressure Meter.

Please do read the user manual carefully and thoroughtly so as to ensure the 

safe usage of this product, and keep the manual well for further reference in 

case you have problems.

Model : TMB-1585

Distributed by:

1byone Products Inc.

2313 E PHILADELPHIA ST STE M, CA, US, , 917618048

www.1byone.com 

 


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INTRODUCTION...................................................................................................................2

General Description

Indications for Use

Safety Information

LCD Display Signal

Monitor Components

List

 

BEFORE YOU START...........................................................................................................7

The Choice of Power Supply

Installing and Replacing the Batteries

Measurement Principle

Setting Date, Time and Measurement Unit

Select the User

MEASUREMENT.................................................................................................................12

Tie the Cuff

Start the Measurement

DATA MANAGEMENT.........................................................................................................14

Recall the Records

Delete the Records

INFORMATION FOR USER................................................................................................17

Tips for measurement

Maintenances

ABOUT BLOOD PRESSURE..............................................................................................19

What are systolic pressure and diastolic pressure?

What is the standard blood pressure classification?

Irregular Heartbeat Detector

Why does my blood pressure fluctuate throughout the day?

Why do I get a different blood pressure at home compared to the hospital?

Is the result the same if measuring on the right arm?

TROUBLESHOOTING........................................................................................................21

SPECIFICATIONS..............................................................................................................22

AUTHORIZED COMPONENT ...........................................................................................23

COMPLIED STANDARDS LIST..........................................................................................24

FCC STATEMENT...............................................................................................................25

EMC GUIDANCE................................................................................................................25

Table of Contents

1

CATALOGUE

CATALOGUE

 


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Safety Information

This manual contains important safety and care information, and  

provides step by step instructions for using the product.

Read the manual thoroughly before using the product.

Features:

 

Maximum 60 records per each user

General Description

3rd technonoly: Measuring during inflation 

(The updated technology in the world)

100mm×68 mm Digital LCD display 

Indications for Use

The 1by one Arm Blood Pressure Meter is digital monitors intended for use in 

measuring blood pressure and heartbeat rate with arm circumference ranging 

from about 22 cm to 42 cm ( about 8¾˝-16½˝ ).

It is intended for adult indoor use only.      

The device is not suitable for measuring the blood pressure of children. Ask your 

doctor before using it on older children. 

The device is not suitable for use on pregnant women, patients with implanted, 

electrocical devices, patients with pre-elcampsia, premature ventricular beats, atrial 

fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or 

arterio-venous shunt or people who received a mastectomy. Please consult your 

doctor prior to using the unit if you suffer from illnesses

Do not take any therapeutic measures on the basis of a self measurement. Never alter 

the dose of a medicine prescribed by a doctor. Consult your doctor if you have any 

question about your blood pressure.

Please keep the unit out of reach of infants, children or pets, since inhalation or 

swallowing of small parts is dangerous or even fatal.

The device has been evaluated clinically using manual cuff/stethoscope auscultation 

as the reference.

Blood pressure measurements determined with this device are equivalent to those 

obtained by a trained observer using the cuff/stethoscope auscultatory method, within 

the limits prescribed by the American National Standard, Manual, electronic, or 

automated sphygmomanometers.”

CAUTION

Symbol for “THE OPERATION 

GUIDE MUST BE READ”

Symbol for “SERIAL NUMBER”

Symbol for “TYPE BF APPLIED 

PARTS”

Symbol for “DIRECT CURRENT”

Symbol for “ENVIRONMENT 

PROTECTION - Electrical waste 

products should not be disposed of 

with household waste. Please recycle 

where facilities exist. Check with your 

local authority or retailer for recycling 

advice”

Symbol for “MANUFACTURE 

DATE”

Caution: These notes must be 

observed to prevent any damage 

to the device.

SN

The signs below might be in the user manual, labeling or other component. 

They are the requirement of standard and using.

2

3

INTRODUCTION

INTRODUCTION

 


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LCD display signal

SYMBOL

DESCRIPTION

Systolic blood pressure

High pressure result

Diastolic blood pressure Low pressure result

EXPLANATION

Pulse per minute

Beats per minute, BPM

Deflating

CUFF air is exhausting of deflating

Memory

The displayed measurement values 

is from the memory. 

mmHg

kPa

Measurement Unit of the blood pressure

Measurement Unit of the blood pressure

Low battery

Batteries are low and need to be replaced

Irregular heartbeat Detection

Grade

The grade of the blood pressure

Current Time

Year/Month/Day, Hour/Minute

(1kPa=7.5mmHg)

(1mmHg=0.133kPa)

Heartbeat

Heartbeat detection during the 

measurement

User A

Start measurement and save the 

measuring results for User A

User B

Irregular heartbeat 

Start measurement and save the 

measuring results for User B

CAUTION

This device is intended only for adult use in homes.

This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is 

not intended for use on extremities other than arm or for functions other than obtaining a blood 

pressure measurement.

If you experience discomfort during a measurement, such as pain in the arm or other complaints, 

press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and 

remove it from your arm. 

On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open 

the cuff immediately. Prolonged high pressure (cuff pressure >300mmHg or constant pressure 

>15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.

Too frequent and consecutive measurements could cause disturbances in blood circulation and 

injuries.

Do not wrap the cuff on the same arm which other monitoring ME EQUIPMENT is applied 

simultaneously, because this could cause temporary loss of function of those simultaneously-used 

monitoring ME EQUIPMENT.

Don’t kink the connection tube during use, otherwise, the cuff pressure may continuously increase 

which can prevent blood flow and result in harmful injury to the PATIENT.

The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable 

anesthetic mixture with air of with oxygen or nitrous oxide.

This unit is not suitable for continuous monitoring during medical emergencies or operations. 

This device cannot be used with HF surgical equipment at the same time.

This device is not intended for patient transports outside a healthcare facility.

To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated 

interference signal or electrical fast transient/burst signal.

The operator shall not touch output of batteries/adapter and the patient simultaneously.

Manufacturer will make available on request circuit diagrams, component parts list etc.

The materials of the cuff have been tested and found to comply with requirements of ISO 

10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation 

reaction.Never apply the cuff over hurt skin.

Do not use the unit in case of existing polyester resp. synthetic allergies.

Be careful to strangulation due to cables and hoses, particularly due to excessive length.

Do not connect the air hose to other medical equipment, as this could cause air to be pumped into 

intravascular systems or high pressure, what could lead to dangerous injuries.

Before use, make sure the device functions safely and is in proper working condition.

Please use the device under the environment which was provided in the user manual. Otherwise, 

the performance and lifetime of the device will be impacted and reduced.

Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. 

Otherwise, it may cause damage to the unit or danger to the user/patients.

Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the 

local guidelines.

Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs 

carried out by authorized service centers. 

Please report to Manufacturer if any unexpected operation or events occur.

The device doesn’t need to be calibrated in two years of reliable service.

Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.

The air is inflating into the cuff.

Inflation

4

5

INTRODUCTION

INTRODUCTION

 


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Monitor Components

List

1.Arm Blood Pressure Meter

4.User manual

2.Cuff  (Type BF applied part)

              (about 22cm~42cm) 

3. Storage bag

In order to get the best effect and protect your Arm Blood Pressure Meter,

please use the right battery and special power adaptor which complies 

with U.S. safety standard. 

• .Open the battery cover.

• .Install the batteries by matching 

the correct polarity, as shown.

• .Replace the cover.

Installing and Replacing the Batteries

CAUTION

Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, do not dispose with other daily trash.
Remove the old batteries from the device and follow your local recycling guidelines.

CAUTION

Replace the batteries whenever the below happen

The                     shows
The display dims

The display does not light up

Do not dispose of batteries in fire. Batteries may explode or leak.

 

The Choice of Power Supply

1.Battery powered mode:

    6VDC 4×AAA batteries(Not Included)

2.AC adaptor powered mode:

   6V     1A

(Please only use the recommended  AC 

adaptor model).(Not Included) 

Please unplug the adaptor to depart from
the using utility power.

(Please use 1byone 

authorized cuff. The size 

of the actual cuff please 

refer to the label on the 

attached cuff.)

Component list of 

pressure measuring system

1 Cuff 

2 Air pipe

3 PCBA

4 Pump

5 Valve

CUFF

 AIR HOSE

AIR CONNECTOR PLUG

LCD DISPLAY

DC POWER SOCKET

MEM BUTTON

START/STOP BUTTON

SET BUTTON

BATTERY COMPARTMENT

 

AC adaptor

 

7

6

BEFORE YOU START

INTRODUCTION

 


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Measurement Principle

Setting Date, Time and Measurement Unit

  It is important to set the clock before using your Arm Blood Pressure 

Meter, so that a time stamp can be assigned to each record that  

is stored in the memory. (The setting range of the year :2014—2054 

time format:12H/24H)

1.When the Arm Blood Pressure 

Meter is off, hold pressing “S” 

button about 3 seconds to enter 

the mode for year setting. 

2.Press “M” button to 

change the [YEAR]. Each 

press will increase the 

numeral by one in a

cycling manner.

3.When you get the right 

year, press “S” button 

to set down and turn to 

next step. You can set

the [DATE FORMAT]

between D/M and M/D

by pressing 'M' button

   This product uses the Oscillometric Measuring method to detect blood pressure. Before 

every measurement, the unit establishes a “zero pressure” equivalent to the air pressure. 

Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations 

generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic 

pressure, and also pulse rate.

    The device also compares the longest and the shortest time intervals of detected pulse 

waves to mean time interval then calculates standard deviation. The device will display a 

warning signal with the reading to indicate the detection of irregular heartbeat when the 

difference of the time intervals is over 25%.

4.Repeat steps 2 and 3 to set the [MONTH] and [DAY]. 

.Repeat steps 2 and 3 to set the [TIME FORMAT] between 12H and 24H. 

5

9

8

BEFORE YOU START

BEFORE YOU START

 


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8.After the unit is set,the LCD will display “done” first, then display

all the settings you have done and then turn off.

7.Repeat steps 2 and 3 to set the [UNIT].

Select the User

1.When the Arm Blood Pressure Meter is off , Press and hold 

'M' button for 2 seconds to enter user setting mode. The user ID

will blink.

2.Then press “M” button again, select the user ID between 

user A and user B.

3. After selecting the suitable user ID, press “S” button to 

confirm. Then the LCD will turn off.

.Repeat steps 2 and 3 to set the [HOUR]  and [MINUTE]. 

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11

10

BEFORE YOU START

BEFORE YOU START

 


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Rest  for 5 minutes before 

measuring.

Wait at least 3 minutes between 

measurements. This allows your 

blood circulation to recover.

For a meaningful comparison, 

try to measure under similar 

conditions. For example, take daily 

measurements at approximately 

the same time, position of upper 

arm, or as directed by a physician.

Tie the cuff

1.Tie the cuff on your upper arm, 

then position the tube off-center 

toward the inner side of arm in 

line with the little finger.

2.The cuff should be snug but not 

too tight. You should be able to 

insert one finger between the 

cuff and your arm.

3.Sit comfortably with your tested 

arm resting on a flat surface. 

2~3cm

.Patients with Hypertension:

The middle of the cuff should be 

at the level of the right atrium of the heart;

Before starting measurement, please sit 

comfortably with legs uncrossed,

feet flat on the floor, back and arm supported.

4

1.When the Arm Blood Pressure Meter is off, press the “START/STOP” 

button to turn on it, and it will finish the whole measurement. 

(Take user A for example.) 

Adjust to zero. 

LCD display

Inflating and measuring. 

Display and save the 

measurement results. 

Start the Measurement

2.Press the “START/STOP” button  

to power off, otherwise it will turn

off within 1 minute.

Tips: Maximum 60 records are both for User A and User B.

Or position the artery mark 

Φ

 over  

the main artery (on the inside of 

your arm).Note: Locate the main 

artery by pressing with 2 fingers 

approximately 2 cm above the 

bend of your elbow on the inside 

of your left arm. Identify where the 

pulse can be felt the strongest. 

This is your main artery.

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12

MEASUREMENT

MEASUREMENT

 


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Recall the Records

1. When the Arm Blood Pressure 

Meter is off, please press “M” button

to show the average value of 

the latest three records. 

(Note: If the records are less than 

3 groups, the LCD will display the 

recent record instead. Take user A

for example.)

2. Press “M” button

or “S” button to get

the record you want.

The most recent record (1) is shown first.  Each new measurement is 

assigned to the first (1) record. All other records are pushed back one 

digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped 

from the list.

The current No. is No. 1.

The corresponding 

time is P.M. 9:37.

The corresponding 

date is May 25   .

CAUTION

The order, date and time 

of the record will be shown

alternately.  

3. If you want to check another user’s records, press “START/STOP” button

to turn off the Arm Blood Pressure Meter when it is in the memory inquiry 

mode. Press and hold 'M' button for 2 seconds to enter into the selecting user 

ID mode, press “M” again to select the user ID between user A and user B,  

press “S” button to confirm the user ID , then press “M” button to check the 

selected user’s measurement records.

th

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14

DATA MANAGEMENT

DATA MANAGEMENT

 


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If you did not get the correct measurement, you can delete all 

results by following steps below. (Take User A for example.)

Delete the Records

1.Hold pressing “M” button  

for 3 seconds when the

Arm Blood Pressure Meter  

is in the memory recall mode ,

the flash display “ User ID+ 

dEL ALL”  will show. 

2.Press “S” button to 

confirm deleting and 

the Arm Blood Pressure 

Meter will display “dEL 

dOnE” and then turn off. 

3. If there is no record. 

the following display will 

show.

Tips for Measurement

Within 1 hour 

after dinner or drinking

Within 20 minutes 

after taking a bath

In a very cold environment

Immediate measurement 

after tea, coffee, smoking 

When talking or moving your fingers

When you want to discharge urine

Measurements may be inaccurate if taken in the following 

circumstances.

Note: To exit out of delete mode

without deleting any records,

press START/STOP button

before pressing "S" button to 

confirm any delete commands.

17

16

INFORMATION FOR USER

DATA MANAGEMENT

 


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Maintenance

In order to get the best performance, please follow the  

instructions below.

What are systolic pressure and diastolic pressure? 

press

artery

vein

blood discharging

Systolic

relax

blood entering

Diastolic  

When ventricles contract and pump blood out of the 

heart, the blood pressure reaches its maximum value 

in the cycle, which is called systolic pressure. When 

the ventricles relax, the blood pressure reaches its 

minimum value in the cycle, which is called diastolic 

pressure.

What is the standard blood pressure classification?

Irregular Heartbeat Detector

CAUTION

The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular 

heart-beat was detected during measurement. Usually this is NOT a cause for concern. 

However, if the symbol appears often, we recommend you seek medical advice. Please note 

that the device does not replace a cardiac examination, but serves to detect pulse irregularities 

at an early stage.

An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is 

measuring the systolic and diastolic blood pressure.During each measurement, 

this equipment records the heartbeat intervals and works out the standard deviation. 

If the calculated value is larger than or equal to 15,the irregular heartbeat symbol 

appears on the symbol when the measurement results are displayed.

Put in a dry place and avoid the sunshine

Avoid intense shaking

and collisions

Using wet cloths to remove dirt

Avoid touching water,

clean it with a dry cloth in case.

Avoid dusty and unstable

temperature environment

Do not attempt to clean the reusable cuff 

with water and never immerse the cuff in 

water.

The chart on the right is the

standard blood pressure

classification published by

American Heart Association 

(AHA).

Only a physician can tell your normal BP range. Please contact a physician if your 

measuring result falls out of the range. Please note that only a physician can tell 

whether your blood pressure value has reached a dangerous point.

CAUTION

AHA Home Guideline for 

Upper Limit of Normal BP

SYS 135 mm Hg
DIA

85 mm Hg

Blood Pressure Category

Normal

Prehypertension

High Blood Pressure

(Hypertension) Stage 1

High Blood Pressure

(Hypertension) Stage 2

Hypertensive Crisis

(Emergency care needed)

Systolic

mmHg (upper#)

Diastolic

mmHg (lower#)

less than 120

120-139

140-159

160 or higher

Higher than 180

and

or

or

or

or

less than 80

80-89

90-99

100 or higher

Higher than 110

This chart reflects blood pressure categories defined by American Heart Association.

19

18

INFORMATION FOR USER

ABOUT BLOOD PRESSURE

 


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Why does my blood pressure 

fluctuate throughout the day?

Is the result the same 

if measuring on the 

right arm?

Why do I get a different 

blood pressure at home 

compared to the hospital?

1. Individual blood pressure varies 

multiple times everyday. It is also affected 

by the way you tie your cuff and your 

measurement position, so please take the 

measurement under the same conditions.

2.If the person takes medicine, the 

pressure will vary more.

3.Wait at least 3 minutes for another 

measurement.

The blood pressure is different even 

throughout the day due to weather, 

emotion, exercise etc, Also, there is the 

“white coat” effect, which means blood 

pressure usually increases in clinical 

settings.

What you need to pay 

attention to when you measure 

your blood pressure at home: 

If the cuff is tied properly. 

If the cuff is too tight or too loose.

If the cuff is tied on the upper arm.

If you feel anxious.

Taking 2-3 deep breaths before 

beginning will be better for measuring.        

Advice: Relax yourself for 4-5 

minutes until you calm down.

It is ok for both arms, but there 

will be some different results for 

different people. We suggest you 

measure the same arm every time.

    This section includes a list of error messages and frequently  

asked questions for problems you may encounter with your Arm 

Blood Pressure Meter . If the products not operating as you think it 

should, check here before arranging for servicing.  

PROBLEM SYMPTOM CHECK THIS

REMEDY

No power

Low

batteries

Error

message

Display will not 
light up.

Batteries are exhausted. Replace with new batteries

Insert the batteries 
correctly

Replace with new batteries

Batteries are inserted

incorrectly.

Display is dim or 
show

Batteries are low.

E 1 shows

E 3 shows

E10 or E11

 shows

E20 shows

The measurement 

process does not detect

the pulse signal.

Loosen the clothing on the

arm and then measure 

again

EExx,shows on 

the display.

A calibration error

occurred.

Retake the measurement.

If the problem persists,

contact the retailer or our

customer service 

department for further 

assistance.Refer to the 

warranty for contact 

information and return 

instructions.

E21 shows

The treatment of the

measurement failed.

Relax for a moment and

then measure again.

AC adaptor is inserted

incorrectly.

Insert the AC adaptor 
tightly

The Arm Blood Pressure

 Meter detected motion,

talking or the pluse is too 

poor while measuring.

Relax for a 

moment and then 

measure again.

The cuff is not secure.

Refasten the cuff and then

measure again.

E 2 shows

The cuff is very tight

The pressure of the

cuff is excess.

Relax for a moment

and then measure again.

Readjust the cuff ,not too 

loose or too tight and then

measure again.

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20

ABOUT BLOOD PRESSURE

TROUBLESHOOTING

 


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About 22cm~42cm

Type BF applied part

WARNING: No modification of this equipment is allowed.

Temperature:-20℃-60℃

Relative Humidity: 10%RH-93%RH

Atmospheric Pressure: 50kPa-106 kPa

Temperature:5℃ to 40℃ 
Relative humidity: ≤85%RH

Atmospheric pressure: 86kPa to 106kPa

Power supply

Battery powered mode: 
6VDC 4×AAA batteries (Not Included)
AC adaptor powered mode:
6V      1A

(Please only use the recommended  AC adaptor 

model).(Not Included) 

Display mode

Measurement mode

Oscillographic testing mode

Measurement range

Measurement perimeter

of the upper arm

Net Weight

Approx.282g(Excluding the dry cells and cuff)

External dimensions

Attachment

Mode of operation

Continuous operation

Degree of protection

Protection against 

ingress of water

IP21

Accuracy

Normal working condition

Storage & transportation

condition

Software Version

V01

Pressure:
5℃-40℃within±3mmHg(0.4kPa) 
pulse value:±5%

Digital LCD   V.A.100mm×68mm

Approx.154mm×106mm×57.1mm

1×storage bag,user manual  

Authorized Component

1.

please use the 1byone authorized adapter. (Not Included)

Adapter
SKU 703US-0003

 (MODEL: KH0601000UW)

         

Input:

100~240V~

50/60Hz, 0.3A Max

Output:

6V      1000mA

Rated cuff pressure: 

0mmHg~300mmHg(0kPa ~ 40kPa)

Measurement pressure: 

SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) 

DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)

Pulse value: (40-199)beat/minute

22

23

SPECIFICATIONS

AUTHORIZED COMPONENT

 


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Complied Standards List

EMC Guidance

1) This equipment needs to be installed and put into service in accordance 

with the information provided in the user manual;

2) Wireless communications equipment such as wireless home network 

devices, mobile phones, cordless telephones and their base stations, 

walkie-talkies can affect this equipment and should be kept at least a 

distance d=3,3m away from the equipment.

(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, 

a typical cell phone with a maximum output power of 2 W yields  d=3, 3m at 

an IMMUNITY LEVEL of 3V/m)  

This device complies with Part 15 of the FCC Rules. Operation is 

subject to the following two conditions: (1) this device may not cause 

harmful interference, and (2) this device must accept any interfer-

ence received, including interference that may cause undesired 

operation.

FCC Statement

Risk management

Labeling

User manual

General Requirements 

for Safety

Electromagnetic 

compatibility

Performance 

requirements and 

Clinical investigation

Software life-cycle 

processes

ISO/EN 14971:2012 Medical devices — Application of 

risk management to medical devices

ISO/EN 15223-1:2012  Medical devices. Symbols to 

be used with medical device labels, labelling and 

information to be supplied. General requirements

EN 1041: 2008  Medical equipment manufacturers to 

provide information

IEC 60601-1: 2005+A1:2012  Medical electrical 

equipment - Part 1: General requirements for basic safety 

and essential performance

IEC 60601-1-11 Medical electrical equipment - Part 

1-11: General requirements for basic safety and essential 

performance - Collateral standard: Requirements for 

medical electrical equipment and medical electrical 

systems used in the home healthcare environment

IEC/EN 60601-1-2:2007  Medical electrical equipment - 

Part 1-2: General requirements for basic safety and 

essential performance - Collateral 

standard:Electromagnetic compatibility - Requirements 

and tests

IEC 80601-2-30:2009 Medical electrical equipment- 

Part 2-30: Particular requirements for the basic safety 

and essential performance of automated non-invasive 

sphygmomanometers

IEC/EN 62304:2006+AC: 2008  Medical device 

software - Software life cycle processes

Usability

IEC 62366 Medical devices - Application of usability 

engineering to medical devices (IEC 62366:2007)

IEC 60601-1-6 Medical electrical equipment - Part 1 

-6 : General requirements for basic safety and 

essential performance - collateral standard : Usability

ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, 

or automated sphygmomanometers

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COMPLIED STANDARDS LIST

EMC GUIDANCE