Electro mechanical medical devices
Definition
The EEMD (Electro mechanical medical devices) family includes medical equipment and their accessories, consumables and spare-parts that operate on electrical energy and/or through some integrated physical mechanism or machinery (mechanical).
MSF guide
See the MSF guide that each mission should have and read!
- Medical equipment management guideline, MSF, 2021
MSF codification
Each type of equipment is identified with a specific root of 3 letters
- +E for the equipment = Medical devices requiring calibration, maintenance, repair, user training and decommissioning (the machine, the apparatus, also called parent device)
- +A for the accessories = Supplementary reusable parts or devices, used in combination with an item of medical equipment, to provide specific or additional functionality (e.g. ultrasound probes, barcode scanner, transport bag, warming sleeve).
- +C for the related consumables = Items requiring periodic replacement. Replacement can be required in order to reduce cross-infection risks (e.g. cannula, mask, anti-bacterial filter, syringe, tubing, etc.) or to ensure continued performance of the device (e.g. air (dust) filters, gaskets, etc.)
- +S for the different spare-parts = Integral components which are replaced in order to restore functioning, safety or physical integrity of the equipment. Spare parts can either be purchased new or, when within manufacturers tolerances and local legislation, be removed and retained for future use during decommissioning of equipment.
Further specification of the code: qualifier per brand, by sequential counting/numbering.
The person defining the needs of the accessories, consumables and spare-parts is
- for accessories => medical staff
- for consumables => logistical or medical staff, depending on the type of consumable: for use (medical) or for technical maintenance (logistical)
- for spare-parts => logistical staff
MSF articles
The different roots for the standard equipment are
| Root | |
BFW+ | Blood / Fluid warmer |
CPA+ | CPAP Continuous Positive Airway Pressure ventilation |
CON+ | Oxygen concentrator |
| OCF+ | Oxygen cylinder filling station |
DEF+ | Defibrillator |
DER+ | Electric dermatome |
DRI+ | Surgical drill |
ECG+ | E.C.G. Electrocardiograph |
EDC+ | Electronic drop counter |
ENP+ | Enteral nutrition pump |
ESU+ | Electro Surgical Unit |
FHD+ | Foetal Heart Doppler |
FLW+ | Fluid warmer |
HEP+ | Heating pad, electrical |
| HEL+ | Headlamp |
INP+ | Infusion pump, general purpose |
LEX+ | Examination light |
LOP+ | Operating light |
MAF+ | Alternating-pressure bed mattress system |
MON+ | Single-patient physiologic monitoring system |
NEC+ | Nebulizer + compressor |
PHO+ | Phototherapy unit for infants |
POX+ | Pulse oximeter |
| FPO+ | Fingertip pulse oximeter |
PUM+ | Airway clearance suction pump |
SAW+ | Saw, oscillating |
SHC+ | Surgical hair clippers |
| SPH+ | Sphygmomanometer |
SYP+ | Syringe pump |
TAO+ | Operating table |
VAC+ | Surgical suction system |
VIC+ | Intensive-care ventilator |
WAI+ | Warmer, infant |
WAU+ | Air heating pad system |
Other families do also contain electro mechanical medical devices: EANE, EDIM, ELAE, ESTE.
Components of equipment
When ordering medical equipment EEMD***E, certain accessories and consumables are delivered with the equipment: they are listed in the technical sheet under “components” and/or “supplied with the article”. These additions are supplied by the manufacturer and/or compiled by the MSF Supply Centres (ESC's) to go with the equipment. This ensures that the equipment can be used correctly upon arrival in the MSF project.
Norms
General standard
IEC = International Electrotechnical Commission
IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012 +AMD2:2020) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission
- It concerns any type of medical electrical equipment without distinction
- It is presented in ten sections
- General: Scope and purpose of the standard. Terminology and definitions, general characteristics of devices.
- Environmental conditions
- Protection against electric shock
- Protection against mechanical shock
- Protection against risks due to unwanted or excessive radiation
- Protection against ignition hazards of flammable anesthetic mixtures
- Protection against excessive temperatures and other risks.
- Accuracy of operating characteristics and protection against hazardous output characteristics.
- Abnormal operation and fault conditions, environmental testing.
- Construction rules
The European EN version of the standard is identical to the IEC standard.
The equipment and all accessories selected by MSF are tested according the primary standard governing medical device design.
Collateral standards
Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, or protection for diagnostic use of X-rays.
- IEC 60601-1-2: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment
- IEC 60601-1-6: Usability
- IEC 60601-1-8: General requirements, tests and guidance for alarm systems
- IEC 60601-1-9: Requirements for environmentally conscious design
- IEC 60601-1-10: Requirements for the development of physiologic closed-loop controllers
- IEC 60601-1-12: Requirements for medical electrical equipment/systems intended for use in the emergency medical services environment
Particular standards
Particular standards for the medical electrical equipment, numbered 60601-2-X / 80601-2-X define the requirements for specific products or specific measurements built into products. These quality standards are listed in the technical sheets per equipment under the “norms”.
- EN 60601-2-2 : Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- EN 60601-2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
- EN 60601-2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
- EN 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- EN 80601-2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- EN 80601-2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
- EN 60601-2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
- EN 60601-2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
- EN 60601-2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- EN 60601-2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- EN 60601-2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- EN 80601-2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- EN 60601-2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- EN 80601-2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
- EN 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- EN 60601-2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
- EN 60601-2-43 : Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
- EN 60601-2-46: Particular requirements for the basic safety and essential performance of operating tables
- EN 80601-2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
- EN 60601-2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
- EN 60601-2-52: Particular requirements for basic safety and essential performance of medical beds
- EN 60601-2-54 : Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy electrocardiographs
- EN 80601-2-55 : Particular requirements for the basic safety and essential performance of respiratory gas monitors
- EN 80601-2-56 : Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- EN 60601-2-57 : Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- EN 80601-2-61 : Particular requirements for basic safety and essential performance of pulse oximeter equipment
- EN 80601-2-67 : Particular requirements for basic safety and essential performance of oxygen-conserving equipment
- EN 80601-2-69 : Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
- EN 80601-2-74 : Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- EN 80601-2-79 : Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
- EN 80601-2-80 : Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
- EN 80601-2-84: Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
Protection against electric shocks
The IEC 60601-1 standard has a significant impact on the product development process, going beyond performance test and verification. This is because product complexity generally yields innumerable potential test cases, permutations, and combinations in both normal and abnormal operating modes, and these cannot be assessed in the final design alone.
While power supplies by themselves are not medical devices and, are therefore, not directly covered by the IEC 60606-1 standard, they are nevertheless integral to the design and operation of medical equipment.
Protection method
All electrical equipment is categorised into classes according to the method of protection against electric shock that is used.This decribes the way the electric equipment is protected agains electric shocks: by being connected to the ground, by double casing ….
For mains powered electrical equipment there are usually two levels of protection used, called "basic" and "supplementary" protection. The supplementary protection is intended to come into action in the event of failure of the basic protection.
- Class I equipment: insulation between live parts and exposed conductive parts with supplementary protection: 3rd protective earth reference point. Symbols seen on earthed equipment
- Class II equipment: Reinforced insulation or double insulation
- Class III equipment: internal power supply or SELV, Very Low Voltage Safety:
- Max 25 V AC (alternating current)
- Max 60 V DC (direct current)
Degree of protection
The degree of protection for medical electrical equipment is defined by the type designation. The reason for the existence of type designations is that different pieces of medical electrical equipment have different areas of application and therefore different electrical safety requirements.
B, BF or CF are classifications of applied parts = parts of the medical device which come in physical contact with the patient.
Types are assigned according to the level of protection to leakage currents
- Type B
- B = "Body"
- equipment operates within a 2 meter radius from the patient but without patient contact
- medical device with non-floating inputs
- average level of electrical protection of the patient
- Type BF
- BF = "Body Floating"
- equipment makes physical contact with the patient
- medical device with floating inputs
- average level of electrical protection of the patient
- CF type
- CF = "Cardiac Floating"
- makes physical contact with the heart
- medical device with floating inputs
- high level of electrical protection of the patient
Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989+AMD1:1999+AMD2:2013
The different degrees of protection described in the standard are
- protection of persons against access to hazardous parts inside the enclosure
- protection of the equipment inside the enclosure against ingress of solid foreign objects
- protection of the equipment inside the enclosure against harmful effects due to the ingress of water
The protection index (IP) indicates the degree of protection of a material against the ingress of solids and liquids.
The format of the index, given by the IEC 60529 standard, is IPyy where the characters y are two numbers and/or a letter. The numbers indicate compliance with the conditions summarised in the tables below. Where no criteria are met, the number may be replaced by the letter X.
Protection against ingress of solid foreign bodies
| Level | Protection against ingress of solid foreign bodies |
| X | No data available |
| 0 | None |
| 1 | Protected against solid foreign objects of 50mm and greater |
| 2 | Protected against solid foreign objects of 12.5mm and greater |
| 3 | Protected against solid foreign objects of 2.5mm and greater |
| 4 | Protected against solid foreign objects of 1.0mm and greater |
| 5 | Dust-protected |
| 6 | Dust-tight |
Protection against ingress of liquids
| Level | Protection against ingress of liquids |
| x | No data available |
| 0 | Non-protected |
| 1 | Protected against vertically falling water drops |
| 2 | Protected against vertically falling water drops when the enclosure is tilted up to 15 degrees |
| 3 | Protected against “spraying” water at an angle up to 60 degrees on either side |
| 4 | Protected against “splashing” water from any direction |
| 5 | Protected against “water jets” from any direction |
| 6 | Protected against powerful “water jets” |
| 7 | Protected against the effects of “temporary immersion” in water |
| 8 | Protected against the effects of “continuous submersion” under water under conditions specified by the manufacturer |
| 9 | Protected against “high pressure and temperature” water jets |
Protection against access to hazardous parts
| Additional letter | Protection against access to hazardous parts |
| A | Protected against access with the back of the hand |
| B | Protected against access with a finger |
| C | Protected against access with a tool |
| D | Protected against access with a wire |
Waste of electrical and electronic equipment (WEEE)
WEEE is a complex mixture of materials and components that because of their hazardous content, and if not properly managed, can cause major environmental and health problems. Moreover, the production of modern electronics requires the use of scarce and expensive resources. To improve the environmental management of WEEE and to contribute to a circular economy and enhance resource efficiency the improvement of collection, treatment and recycling of electronics at the end of their life is essential.
To address these problems pieces of EU legislation have been put in place:
- The Directive on waste electrical and electronic equipment (Directive 2012/19/EU = WEEE Directive) which sets collection, recycling and recovery targets for electrical goods.
- The Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive) which specifies maximum levels for 10 substances (heavy metals and phthalates)
Substances subject to limitations as referred to in Article 4 (1) and maximum concentration values by weight in homogeneous materials
- Lead (0.1%)
- Mercury (0.1%)
- Cadmium (0.01%)
- Hexavalent chromium (0.1%)
- Polybrominated biphenyls (PBB) (0.1%)
- Polybrominated diphenyl ethers (PBDEs) (0.1%)
Regarding the disposal of the equipment / apparatus: it must be dismantled and all pieces must be segregated based on matter used: plastic, metallic (iron, aluminium, ...), electronic
- WARNING: All electronic parts are classified as WEEE, sub-category of Hazardous waste.
- Most of consumables can be burnt in a normal incinerator.
Contact your WatSan and Biomedical advisors to receive the detailled procedure about management of each waste parts.
Quality standards related to batteries
- IEC 62133, 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems, Part2: Lithium systems (AMD1:2021)
The use of batteries in medical equipment
Types of batteries
UN Number | Proper Shipping Name and Description Désignation exacte d’expédition et Description | Hazard Class Classe |
UN2794 | Batteries, Wet, Filled with Acid Accumulateurs électrique remplis d’électrolyte, liquide acide | 8 |
UN2795 | Batteries, Wet, Filled with Alkali Accumulateurs électrique remplis d’électrolyte, liquide alcalin | 8 |
UN2800 | Batteries, Wet, Non-spillable Accumulateurs électrique inversables remplis d’électrolyte liquide | 8 |
UN3028 | Batteries, Dry, Containing Potassium Hydroxide Solid Accumulateurrs électriques, secs, contenant de l'hydroxyde de potassium solide | 8 |
UN3090 | Lithium Metal Batteries Piles au lithium métal | 9 |
UN3091 | Lithium Metal Batteries Contained in Equipment or Lithium Metal Batteries Packed with Equipment Piles au lithium metal contenues dans ou emballées avec un équipement | 9 |
UN3292 | Batteries, Containing Sodium Eléments d’accumulateurs au Sodium | 4.3 |
UN3480 | Lithium Ion Batteries Piles au lithium ionique | 9 |
UN3481 | Lithium Ion Batteries Contained in Equipment or Lithium Ion Batteries Packed with Equipment Piles au lithium ionique contenues dans ou emballées avec un équipement | 9 |
Transport of batteries
US Regulations for batteries: all batteries, regardless of chemistry (e.g., alkaline, lithium, lead, nickel metal hydride, carbon zinc, etc., or battery powered products) are subject to 49 CFR 173.21(c) in the U.S. hazardous materials regulations.
Lithium ion and lithium metal cells and batteries
Lithium ion and lithium metal cells and batteries are subject to specific packaging, marking, labeling, and shipping paper requirements.
The regulations that govern the transport of lithium ion and lithium metal cells and batteries are very complex.
Classification (DGR 3.9.2.6): Lithium batteries are classified in Class 9 – Miscellaneous dangerous goods as:
- UN 3090, Lithium metal batteries; and
- UN 3480, Lithium ion batteries
or, if inside a piece of equipment or packed separately with a piece of equipment to power that equipment as:
- UN 3091, Lithium metal batteries contained in or packed with equipment; and
- UN 3481, Lithium ion batteries contained in or packed with equipment.
Since 2016, all lithium ion cells and batteries (UN 3480) and lithium metal cells and batteries (UN 3090) shipped by themselves are forbidden for transport as cargo on passenger planes. Transporting the batteries is organized by Packaging Instructions (PI) numbers. All packages must bear a «Cargo Aircraft Only» label, in addition to existing marks and/or labels.
Lead acid batteries
Lead acid batteries are listed as Class 8 Corrosive hazardous materials in the U.S. and international hazardous materials (dangerous goods) regulations (IATA) and also are subject to specific packaging, marking, labeling, and shipping paper requirements. “Nonspillable” lead acid batteries are provided an “exception” to the regulations if certain testing and marking requirements are met.
“Dry cell” batteries
“Dry cell” batteries, such as alkaline, nickel cadmium, and carbon zinc are not listed as hazardous materials or dangerous goods in the U.S. and international regulations. However, the batteries must be packed in a manner that prevents the generation of a dangerous quantity of heat and short circuits and packaged in strong outer packaging.
Nickel metal hydride batteries
Nickel metal hydride batteries are listed as Class 9 hazardous materials/dangerous goods (UN3496). When shipped by vessel in quantities over 100 kg they must be shipped as fully-regulated Class 9 hazardous materials/dangerous goods. In all other cases (when shipped via road, rail and air), they may be offered as dry cell batteries in accordance with the applicable Special Provisions.
Handling used batteries
The Batteries Directive 2006/66/EC (consolidated version in 2018): it intends to contribute to the protection, preservation and improvement of the quality of the environment by minimising the negative impact of batteries and accumulators and waste batteries and accumulators.
Properly use and dispose of batteries or they may leak or explode
Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100°C (212°F) or incinerate. Dispose of used cells promptly.
