NEB 150 MINI - Medical inhaler MICROLIFE - Free user manual and instructions

Product type	Compressed air nebulizer for aerosol therapy
Brand	Microlife
Model	NEB 150 MINI
Dimensions (L x W x H)	165 x 112 x 112 mm
Weight	Approximately 850 g
Power supply	230 V, 50 Hz AC, ≤ 1000 mA
Nebulizer capacity	Min. 2 ml / Max. 6 ml
Aerosol output	0.06 ml/min (with NaF)
Median aerodynamic diameter (MMAD)	2.07 μm
Respirable fraction (< 5 μm)	72%
Noise level	52 dBA
Operating cycle	30 min on / 30 min off
Warranty	5 years
Routine maintenance	Clean and disinfect after each use; nebulizer replaceable every 6 months to 1 year
Air filter replacement	Every 200 hours of use or 1 year
Included accessories	Nebulizer kit, tubing, mouthpiece, adult mask, child mask, nasal mask, air filter
Protection class	Class II, applied part type BF, IP21
Standards	CE (medical device class IIa), compliant with EU MDR 2017/745

Frequently Asked Questions - NEB 150 MINI MICROLIFE

How to use the NEB 150 MINI inhaler?

Assemble the nebulizer kit, fill it with the prescribed medication without exceeding the max mark (6 ml). Connect the tubing to the pump and to the mains socket. Set the On/Off switch to "I". Use the mouthpiece or mask as prescribed. Sit upright during inhalation. Turn off after 30 minutes and let it cool for 30 minutes before next use.

How to clean and disinfect accessories?

After each use, disassemble the nebulizer, mouthpiece, and masks. Rinse under running water for 10 seconds, then wash with a solution of hot water and dish soap for 5 minutes while scrubbing. Rinse for 30 seconds. Disinfect the nebulizer and mouthpiece by immersing them in boiling water for 5 minutes. For masks, use a 2% sodium hypochlorite solution for 15 minutes, then rinse with sterile water. Dry by running the device for 10-15 minutes.

When should I replace the nebulizer?

The nebulizer should be replaced after 6 months to 1 year of use, or sooner if deformed, cracked, or clogged. It can be cleaned and disinfected up to 360 times.

How to replace the air filter?

The air filter is located in the designated compartment. It should be replaced after 200 hours of use or every year. Check it every 10 to 12 treatments: if it is brown or damp, replace it. Use only original filters and never operate the device without a filter.

What to do if the device does not nebulize or nebulizes very weakly?

Check that the tubing is properly connected on both sides, not bent or blocked. Ensure the nebulizer is correctly assembled and the nozzle is not clogged. Also check that medication has been added. If the problem persists, replace the nebulizer.

Can I use any medication with this inhaler?

No, use only medications prescribed by your doctor for inhalation. Check the medication leaflet for contraindications. Do not use quick-relief medications in case of a potentially life-threatening asthma attack.

Is the inhaler suitable for children?

Yes, it is intended for children over 2 years, adolescents, and adults. A child mask is included. Always supervise use by a child.

What is the warranty for the NEB 150 MINI?

The warranty is 5 years from the date of purchase. It covers manufacturing defects. Accessories (nebulizer, masks, filters, etc.) are excluded from warranty. For any claims, contact your dealer or Microlife customer service.

How to dispose of the device at end of life?

This product is subject to European directive 2012/19/EU (WEEE). Do not dispose of it with household waste. Take it to a collection point for electronic waste. Plastic accessories must be cleaned and disinfected before disposal.

Can I use the inhaler while lying down?

No, it is recommended to sit with back straight and relaxed during inhalation. Do not lie down, as this could compress the airways and reduce treatment effectiveness.

USER MANUAL NEB 150 MINI MICROLIFE

Gloxiare Medical Technology Co., Ltd

7月1日，30日美国独立劳动争议

Beneda Industria Zone, Assisi Toxin.

Phone: [phone]

Done with Life science

Piazza Alcama 10, 00153 Bonnelliary

www.donewe.com/contacts

Importer

Marcille OAB

1. LUKSO K 32

www.indiclib.com

(四)本次股东大会的召集和召开程序

C€0123

microlife®

microlife AR → 121 FA → 128 10 GR → 113

NEB 150 MINI

Compressor Nebuliser

LVE → 291 58 LTSI → 368 66 EEF → 4315 7 5022 8 AR → 121 FA → 128 GR I → 113

IBNI-H 1SD MINI N S V10274

Revision Date: 2024-08-04

Microlife NEB 150 MINI Microlife NEB 150 MINIGuarantee Card

Technical diagram of a portable air purifier with labeled parts including fan, socket, and plug

Technical diagram showing three mechanical components with labeled parts (⑤, ⑥) and a connection point (⑦-⑧)

Illustration of two hands holding a mechanical component, one with a handle and the other with a handle (no text or symbols)

Technical diagram of a medical or surgical device with numbered parts labeled ① through ⑪

① Piston compressor
② Power lead
③ ON/OFF Switch
④ Air filter compartment
⑤ Nebuliser
-a: Vaporiser head
⑥ Air tube
⑦ Mouthpiece
⑧ Adult face mask
⑨ Child face mask
⑩ Assembling nebuliser kit
⑪ Nose piece
⑫ Air filter

This product is subject to European Directive 2012/19/EU on waste electrical and electronic equipment and is marked accordingly. Never dispose of electronic devices with household waste. Please seek out information about the local regulations with regard to the correct disposal of electrical and electronic products. Correct disposal helps to protect the environment and human health.

Read the instructions carefully before using this device.

Type BF applied part

Class II equipment

Serial number

Reference number

Manufacturer

Date of manufacture

ON

OFF

IP21

Protection against solid foreign objects and harmful effects due to the ingress of water

Authorized representative in the European Community

Medical device

Importer

Caution

Single patient multiple use (for applied parts only)

Humidity limitation for operating and storage

Temperature limitation for operating or storage

Ambient pressure limitation

Unique Device Identifier

Type number

C€0123

CE Marking of Conformity

Intended use:

The device is an aerosoltherapy system suitable for domestic use. The device is designed for the production of compressed air to operate a small volume nebuliser for the production of medical aerosol for lung respiratory disorders.

Patient population:

The device is intended for use with children from 2 years old, adolescent and adult patients.

Intended user:

The use of the device does not require a specific knowledge or professional ability. The patient is the intended operator except in case of child and patient that required special assistance.

Indications:

Lung acute or chronic diseases of respiratory disorders organs, or inflammation of the upper respiratory system.

Contra-indications:

The device is not indicated to be used with quick-relief medications during life-threatening asthma attacks. No contraindications exist to the administration of aerosols by inhalation. Contraindications related to the medicine used must be checked on the medicine package leaflet. Consult your physician in case of doubts.

Dear Customer,

This nebuliser is an aerosol therapy system suitable for domestic use. This device is used for the nebulisation of liquids and liquid medication (aerosols) and for the treatment of the upper and lower respiratory tract.

If you have any questions, problems or want to order spare parts please contact your local Microlife-Customer Service. Your dealer or pharmacy will be able to give you the address of the Microlife dealer in your country. Alternatively, visit the internet at www.microlife.com where you will find a wealth of invaluable information on our products.

Stay healthy – Microlife Corporation!

Table of contents

1. Important safety instructions
2. Preparation and usage of this device
3. Cleaning and disinfecting
4. Maintenance, Care and Service
   Replacement of the nebuliser Replacement of the air filter
5. Malfunctions and actions to take
   The device cannot be switched on The nebuliser functions poorly or not at all
6. Guarantee
7. Disposal
8. Technical specifications

1. Important safety instructions

• Use the device only as described in this manual and therefore as an aerosoltherapy system, following the indications of your doctor. Any use different from the intended one is to be considered improper and hence dangerous; the manufacturer cannot be held liable for any damage caused by improper, incorrect and/or unreasonable use, or if the equipment is connected to electrical installations which do not comply with current safety regulations.
• Keep the user manual for future reference.
• Do not operate the unit in presence of any anesthetic mixture inflammable with oxygen or nitrogen protoxide.
• The correct functioning of the equipment can be affected by electromagnetic interferences which exceed the limits indicated by the European standards in force. In case this device interferes with other electrical devices, move it and plug it into a different power socket.
• In case of failure and/or malfunction, read the «Malfunctions and actions to take» section in the user manual. Do not handle or open the compressor housing.
• For repair operations address only to a technical service centre authorized by the manufacturer and require the use of original spare parts. The non-observation of the above mentioned indications can compromise the device safety.
• Comply with the safety regulations concerning the electrical devices and in particular:
  — use only original applied parts and components;
  — never submerge the unit in water;
  — never wet the device, it is not protected against water penetration;
  — never touch the unit with wet or moist hands;
  — do not leave the unit exposed to the weather elements;
  — place the unit on a stable and horizontal surface during its operation;
• the use of this device by children and people with disabilities requires always the close supervision by an adult with full mental faculties;
  — do not pull the power cord or the device itself to unplug it from the power socket;

• the power plug is the separation element from the grid power; keep the plug accessible when the device is in use.

• Before plugging in the device, make sure that the electrical rating, shown on the rating plate on the bottom of the unit, corresponds to the mains rating.

• In case the power plug provided with the device does not fit your wall socket, contact qualified personnel for a replacement plug with that of a suitable one. In general, the use of adapters, simple or multiple, and/or extension cables is not recommended. If their use is indispensable, it is necessary to use types complying with safety regulations, paying attention that they do not exceed the maximum power limits, indicated on adapters and extension cables.
• Do not leave the unit plugged in when not in use; unplug the device from the wall socket when it is not in operation.
• The installation must be carried out according to the instructions of the manufacturer. An improper installation can cause damage to persons, animals or objects, for which the manufacturer cannot be held responsible.
• The power cord of this device cannot be replaced by the user. In case of a power cord damage, address to a technical service center authorized by the manufacturer for its replacement.
• The power supply cord should always be fully unwound in order to prevent dangerous overheating.
• Before performing any maintenance or cleaning operation, turn off the device and disconnect the plug from the main supply.
• Some parts of the unit are so small that they may be swallowed by children; keep the equipment out of children's reach.
• If you decide not to use the device any longer, it is recommended to dispose of it according to the current regulations.
  • Make sure to:
  — use this device only with medicines prescribed by your doctor;
  — make the treatment using only the applied parts recommended by your doctor depending on the pathology;
• use the nosepiece applied part only if expressly indicated by your doctor and paying attention to NEVER introduce the bifurcations in the nose, but only bringing them as close as possible.
• Check in the medicine instruction leaflet for possible contraindications for use with common aerosol therapy systems.

• To avoid strangulation and entanglement, keep cable and air tubes out of reach of young children.

• Do not position the equipment so that it is difficult to operate the disconnection device.

• Nebuliser and applied parts are single patient use. Device is multi-patient use.
• This nebulising system is not suitable for use in anaesthetic breathing system or a ventilator breathing system. The patient cannot undergo MRI scan while using this device.
• This device is designed to nebulise solution and suspension liquids.
• Do not use this device if you think it is damaged or notice anything unusual.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the «Technical specifications» section.
• The use of this device is not a replacement for visiting the doctor. In case of no health improvement after treatment consult your doctor again.

2. Preparation and usage of this device

• The device must be checked before each use in order to identify any malfunctions and/or damage caused during transportation and/or storage. During inhalation, sit upright and relaxed to avoid compressing the airways and impairing treatment effectiveness. The applied parts must be used only with a single patient, it is not recommended to use them with several patients.
• After unpacking the device, check it for visible damages or defects; pay particular attention to cracks in the plastic housing, which may expose electrical components. Check if the applied parts are intact.
• Before using the device, proceed with the cleaning operations as described in the chapter «Cleaning and disinfecting».
• Assemble the nebuliser kit ⑩. Ensure that all parts are complete.
• Fill the nebuliser with the inhalation solution as per your doctor's instructions. Ensure that you do not exceed the maximum level.
• Connect the nebuliser with the air tube ⑥ to the compressor ① and plug the power lead ② into the socket (230V 50 Hz AC).
• To start the treatment, set ON/OFF switch ③ into the «I» position.

• The mouthpiece ⑦ gives you a better drug delivery to the lungs.

• Choose between adult ⑧ or child face mask ⑨ and make sure that it encloses the mouth and nose area completely.

• Use all applied parts including the nose piece ⑪ as prescribed by your doctor.

• During inhalation, sit upright and relaxed at a table and not in an armchair, in order to avoid compressing your respiratory airways and impairing the treatment effectiveness. Do not lie down while inhaling. Stop inhalation if you feel unwell.

• Inhale the aerosol solution using the prescribed applied part.

• Once you have finished the treatment, switch the appliance off by pressing the ON/OFF switch ③.
• Empty the remaining medication from the nebuliser and clean the device as described in the section «Cleaning and disinfecting»

This device was designed for intermittent use of 30 min. On / 30 min. Off. Switch off the device after 30 min. use and wait for another 30 min. before you resume treatment.

The device requires no calibration.

Tampering with the device is absolutely forbidden.

No modification to the device is permitted.

3. Cleaning and disinfecting

Device(s): Aerosoltherapy nebuliser applied parts

Before the first use and after each treatmentFollow carefully the cleaning and disinfection instructions of the applied parts as they are very important for the device performances and the therapy success.Use original applied parts only.Do not clean or disinfect the air tube.The applied parts cannot be cleaned and disinfected by automated method.Do not boil nor autoclave the masks.

Limitations on processing

The nebuliser must be replaced after a long period of inactivity, in case it shows deformations or breakings, or when the nebulser nozzle is obstructed by dry medicine, dust, etc. We recommend to replace the nebuliser after a period between 6 months and 1 year, depending on the usage. The maximum times of cleaning and disinfection of the nebulizer are 360 times.The maximum times of cleaning and disinfection of the mask, the nosepiece and the mouth-piece are 360 times.

Instructions
Preparation before cleaning	Detach the air tube from the nebuliser.Detach the mouthpiece or nosepiece or mask from the nebuliser.Make sure that all residual volume is removed from the nebuliser.Disassemble the nebuliser 5 by turning the top counterclockwise and remove the medicine conduction cone.Note:To avoid microbial growth and residual drug drying, clean and disinfect the applied parts immediately after each use.
Cleaning Briefly	rinse all parts in running tap water for at least 10 seconds beforehand.Mix little dish detergent and warm tap water (i.e. FAIRY brand dish washing liquid for hand washing in a ratio of 2 ml : 1 L) in a clean container.Immerse the components of disassembled nebulser, the mask, the mouthpiece and the nosepiece into the mixed water for about 5 min.And then scrub all the surface of all the components with clean and small brush for at least 8 times.Afterwards rinse all parts thoroughly in running tap water at least 30 seconds, to fully remove any possible dish washing liquid residue.
Disinfection	After cleaning, disinfect all of the disassembled parts (only parts that have been cleaned can be disinfected effectively).Boil the disassembled nebuliser, the mouthpiece and the nosepiece for 5 minutes in boiling tap water.Immerse the mask in a 2% sodium hypochlorite (NaOCl) solution for 15 minutes, (i.e. a solution made from the disinfecting agent Amuchina® or a 2% sodium hypochlorite solution mixed by your pharmacist). Afterwards immerse the mask with sterile water for 3 min, and then rinse all the surface of the mask with other clean sterile water twice, to fully remove any possible residue of the disinfectant solution.
Drying • Reassemble the nebuliser components and connect it to the air-outlet, switch the device on and let it work for 10 –15 minutes.Let all parts dry completely before reassembling and reuse to avoid risk of germ grow.Care needs to be taken not to contaminate the parts after they have been cleaned and disinfected. Contamination can be avoided by good hand washing and not touching the inside sections of the device when laying them out to dry or when reassembling.
Inspection Inspect all product components after each cleaning and disinfection. Replace any broken, misshapen or seriously discolored parts.
Packaging Pack dry parts in a clean and sealed container when not in use. Do NOT pack wet or damp parts.
Storage Storage conditions refer to «Technical specifications».Note: re-clean and re-disinfect the parts if they are stored more than one day.

Transportation

After cleaning and disinfection, always transport the parts with clean and sealed container. Contamination can be avoided by good hand washing and not touching the inside sections of the parts when taking out and re-assembling the parts for use.

The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing facility, achieves the desired result. This requires verification and/or validation and routine monitoring of the process.

4. Maintenance, Care and Service

Order all spare parts from your dealer or pharmacist, or contact Microlife-Service (see foreword).

Replacement of the nebuliser

Replace the nebuliser ⑤ after a long period of inactivity, in cases where it shows deformities, breakage, or when the vaporiser head ⑤-a is obstructed by dry medicine, dust, etc. We recommend to replace the nebuliser after a period between 6 months and 1 year depending on the usage.

Only use original nebulisers!

Replacement of the air filter

In normal conditions of use, the air filter ⑫ must be replaced approximately after 200 working hours or after each year. We recommend to periodically check the air filter (10 – 12 treatments) and if the filter shows a grey or brown colour or is wet, replace it. Extract the filter and replace it with a new one.

Do not try to clean the filter for reusing it.

The air filter shall not be serviced or maintained while in use with a patient.

Only use original filters! Do not use the device without filter!

5. Malfunctions and actions to take

The device cannot be switched on

• Ensure the power lead ② is correctly plugged into the socket.
• Ensure the ON/OFF switch ③ is in the position «I».
• Make sure that the device has been operating within operating limits indicated in this manual (30 min On / 30 min Off).

The nebuliser functions poorly or not at all

• Ensure the air tube ⑥ is correctly connected at both ends.
• Ensure the air tube is not squashed, bent, dirty or blocked. If necessary, replace with a new one.
• Ensure the nebuliser ⑤ is fully assembled and the vaporiser head ⑤-a is placed correctly and not obstructed.
• Ensure the required medication has been added.

6. Guarantee

This device is covered by a 5 year guarantee from the date of purchase. During this guarantee period, at our discretion, Microlife will repair or replace the defective product free of charge. Opening or altering the device invalidates the guarantee.

The following items are excluded from the guarantee:

• Transport costs and risks of transport.
- Damage caused by incorrect application or non-compliance with the instructions for use.
• Damage caused by accident or misuse.
- Packaging/storage material and instructions for use.
• Regular checks and maintenance (calibration).
- Applied and wearing parts: Nebuliser, masks, mouthpiece, nose piece, tube, filters, nasal washer (optional).

Should guarantee service be required, please contact the dealer from where the product was purchased, or your local Microlife service. You may contact your local Microlife service through our website: www.microlife.com/support

Compensation is limited to the value of the product. The guarantee will be granted if the complete product is returned with the original invoice. Repair or replacement within guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

7. Disposal

Item Component Disposal Description

1 Device 1 The component mainly includes plastic and electronic components. All comply with RoHS and REACH, and all could be safety disposal. This product is subject to European Directive 2012/19/EU on waste electrical and electronic equipment and is marked accordingly. Never dispose of electronic devices with household waste. Please seek out information about the local regulations with regard to the correct disposal of electrical and electronic products.

2 Applied parts: air tube 6, nebuliser 5, nose piece 11, mouthpiece 7, masks 8 / 9 The components are plastic. All comply with ROHS and REACH. Before disposal, all the applied parts should be cleaned according to manual instructions and then disinfected by boiling for 5 minutes.

8. Technical specifications

Model: NEB 150 MINI

Type: GCE855

AEROSOL PERFORMANCES ACCORDING TO EN ISO

27427:2019 based on adult ventilatory pattern with

Sodium Fluoride (NaF):

Aerosol output: 0.67 ml

Aerosol output rate: 0.06 ml/min.

Percentage of fill

volume emitted per

min: 1.38 %

Residual Volume: 0.8 ml

Particle size (MMAD): 2.07 μm

GSD (geometric

standard deviation): 2.1 μm

RF (respirable

fraction < 5 μm): 72 %

Large particle range

(> 5 μm): 28 %

Middle particle range

(2-5 μm): 22 %

Small particle range

(< 2 μm): 50 %

Operating air flow: 2.5 l/min.

Acoustic noise level: 52 dBA

Power source: 230V 50 Hz AC

Current: ≤ 1000 mA

Power lead length: 1.4 m

Nebuliser capacity: min. 2 ml; max. 6 ml

Operating limits: 30 min. On / 30 min. Off

Operating 10 – 40 °C / 50 – 104 °F

conditions: 10 – 95 % relative maximum humidity

700 – 1060 hPa Atmospheric pressure

Storage and shipping -25 - +70 °C / -4 - +140 °F

conditions: 10 – 95 % relative maximum humidity

700 – 1060 hPa Atmospheric pressure

Weight: approx. 850 g

Dimensions: 165 x 112 x 112 mm

IP Class: IP21

Reference to EN ISO 27427; EN 60601-1; EN 60601-

standards: 1-2; EN 60601-1-6; IEC 60601-1-11

Expected service life: 500 hours

Class II device as regards protection against electric shocks. Nebuliser, mouthpiece and masks are type BF applied parts.

The technical speci without prior notice.

Please report any serious incident that has occurred in relation to the device, injury or adverse event to the local competent authority and to the manufacturer or to the european authorised representative (EC REP).

Vigilance contact point:

https://ec.europa.eu/growth/sectors/medical-devices/contacts AEROSOL CHARACTERISTICS IN ACCORDANCE WITH REGULATION EN ISO27427

Standards applied:

Electric safety standards CEI EN 60601-1 electromagnetic compatibility according to CEI EN 60601-1-2.

The device is a Class IIa medical device. Device complies with European Regulation on medical devices EU MDR 2017/745. Important information regarding Electromagnetic Compatibility (EMC): This product, manufactured by Globalcare Medical Technology Co., Ltd., conforms to the Electromagnetic Compatibility (EMC) standard EN 60601-1-2:2015/A1:2021. Further documentation in compliance with this EMC standard is available from Microlife on www.microlife.com/electro-magnetic-compatibility.

Microlife NEB 150 MINI

SV

https://ec.europa.eu/growth/sectors/medical-devices/contacts

AEROSOLEGENSKAPER I HENHOLD TIL FORORDNING

EN ISO27427

Microlife Corporation!

Turinys

https://ec.europa.eu/growth/sectors/medical-devices/contacts

AEROZOLIO CHARAKTERISTIKOS PAGAL REGLAMENTA

EN ISO27427

Taikomi standartai

electro-magnetic-compatibility.

Microlife NEB 150 MINI

EE

① Kolbkompressor
② Toitejuhe
③ ON/OFF lüliti
④ Ôhufiltri pesa
⑤ Nebulisaator -a: Pihusti pea
⑥ Ôhuvoolik
⑦ Huulik
⑧ Näomask (täiskasvanule)
⑨ Näomask (lapsele)
⑩ Nebulisaatori kokku panemine
⑪ Ninaotsik
⑫ Öhufilter

https://ec.europa.eu/growth/sectors/medical-devices/contacts AEROSOOLIDE OMADUSED STANDARDI EN ISO27427 KOHASELT

Kohaldatavad standardid:

Elektriohutusstandardid CEI EN 60601-1 elektromagnetiline ühilduvus standardi CEI EN 60601-1-2 kohaselt.

Seade on Ila klassi meditsiiniseade. Seade vastab Euroopa meditsiiniseadmete määrusele EU MDR 2017/745.

www.microlife.com/support.

Volumen residual: 0.8 ml

Tamaño de partícula

(MMAD): 2.07 μm

https://ec.europa.eu/growth/sectors/medical-devices/contacts

CARACTÉRISTIQUES DES AÉROSOLS CONFORMÉMENT

À LA RÉGLEMENTATION EN ISO27427

Normes appliquées :

respirabile (< 5 μm):

Intervallo particelle 28 %

grandi (> 5 μm):

Range particelle 22 %

medie

(2-5 μm):

Range particelle 50 %

piccole

(< 2 μm):

Flusso aria 2.5 l/min.

operativo:

Livello sonoro: 52 dBA

https://ec.europa.eu/growth/sectors/medical-devices/contacts EN ISO27427 YÖNETMELİĞİNE UYGUN AEROSOL ÖZELLİKLERİ

Volume residual: 0.8 ml

https://ec.europa.eu/growth/sectors/medical-devices/contacts CARACTERÍSTICAS DO AEROSSOL EM CONFORMIDADE COM O REGULAMENTO EN ISO27427

Normas aplicadas:

Vigilance contact point:

https://ec.europa.eu/growth/sectors/medical-devices/contacts AEROSOLKARAKTERISTIEKEN VOLGENS VOORSCHRIFT EN ISO27427

Toegepaste normen:

Elektrische veiligheidsnormen CEI EN 60601-1 elektromagnetische compatibiliteit volgens CEI EN 60601-1-2.

https://ec.europa.eu/growth/sectors/medical-devices/contacts

medical-devices/contacts

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