Protection against patient entrapment in non moving parts
Types of injuries caused due to entrapment in Medical beds …
To save the patient from injuries that may be caused due entrapment in non moving parts of medical bed, international standards are being made. Testing is mandatory for all hospital medical beds both for children and adults as per IEC 60601-2-52 and BS EN 50637.
Compliance testing is done in ITC India Pvt Ltd as per IEC 60601 for all medical equipment. For any testing requirement please mail email@example.com or visit www.itcindia.org.
201.9.1 Mechanical HAZARDS of ME EQUIPMENTS
- Selection of SIDE RAILS Compliance is checked before and after application of the SIDE RAIL strength and latch reliability tests.
- Selection of mattress: Compliance is checked with the MATTRESS SUPPORT PLATFORM in the flat position unless otherwise noted as indicated in Table 201.101. The test shall be performed with the SIDE RAIL in all raised and locked positions. Compliance is checked by the following tests and inspection of the RISK MANAGEMENT FILE.
Entrapment test tool Sub Clauses – 201.5.101
The dimensions and weight of the cone TOOL and cylinder TOOL are derived from the following observations
- Mass of head for ADULTS has to be considered both in the 60 and 40 diameter TOOLS in order to include persons with an atypical anatomy and older CHILDREN. A 4 year old, 95th percentile child’s head is 3.2 kg. Weight of TOOLS 3.3 kg has been chosen for safety reasons.
- Area of Tool representing neck diameter (40 mm): The neck diameter of 5th percentile child 0 – 3 months is 46 mm. We have to consider compression of tissue. The 5th percentile 12 year old child’s diameter is 72 mm; the mean is 88 mm. But the 5th percentile 18 year old is only 61 mm.
- Area of TOOL representing chest breadth (300 mm): The chest breadth of 12 years, 95th percentile: 265 mm; Maximum head diameter (chin to back of head) 12 years, 95th percentile: 256 mm;
- Area of TOOL representing head breadth (60 mm):
- Jaw breadth 0-3 months, 5th percentile 57 mm;
- Face breadth, frontal (brow ridges) 2 years, 5th percentile 73 mm; 12 years old 79 mm.
- For slipping out of bed feet first: Chest depth 0 – 3 months 5th percentile 80 mm, 3rd percentile girl 0-2 months from Netherlands 61 mm
Safe Working Load Test on Medical Beds As Per IEC 60601-2-52
All the medical beds and bed lifts must be marked with the maximum patient weight and the safe working load of the bed. The safe working load test is performed for patient safety, while serving for support or immobilization of the patient, risk of physical injuries and accidental loosening of fixing shall be minimize.
- Safe Working load for medical bed must be at least 1700 N. The sum of minimum loads considered as below:
- 1350 N, estimated to a mass of 135 kg of the PATIENT
- 200 N, estimated to a mass of 20 kg of the mattress
- 150 N, estimated to a mass of 15 kg of both the attachments and the mass of the load supported by attachments but PATIENT weight is excluded
- The Safe Working Load of Bed lifts must be at least 2200 N. The sum of different loads is as follows:
- 1 350 N, estimated to a mass of 135 kg of the PATIENT.
- 200 N, estimated to a mass of 20 kg for the mattress.
- 150 N, estimated to a mass of 15 kg for both the attachments and
- Mass of the load supported by those attachments but excluding patient weight.
- 500 N, corresponding approximately to a mass of 50 kg for those parts of the MEDICAL BED 655 intended to be lifted by the BED-LIFT.
- For a foot rest, the part of the SAFE WORKING LOAD representing the mass of PATIENTS is dispense more in area of 0.1 m2 or whatever is available.
- The SAFE WORKING LOAD of the LIFTING POLE (included PATIENT handle) must be at least 750 N.
ITC India pvt ltd is performing Conduits Electrical safety testing as per IS/ IEC standards.Manufacturer’s are most welcome to get their conduits tested. This will a necessary requirement for business growth as product will sells fast in the market, if they are ISI marked. For more details write to firstname.lastname@example.org or visit www.itcindia.org
||List of tests as per IS standard
||Equipment required as per IS standard
| 9537 part 1
||Conduits for electrical installations
| 9537 part 2
||Rigid steel conduits
||1. Marking as per Cl. 6
2. Dimensions as per Cl. 7
3. Construction as per Cl. 8
4. Bending Test as per Cl. 9.2
5. Compression Test Cl. 9.3
6. External Influences Cl. 13
|Gauges, measuring tape, vernier caliper, micrometer, bending device, bending aid, compression test apparatus, conditioning chamber
| 9537 Part 3
||Rigid plain conduits of insulating materials
|1. Marking as per Cl. 6.1
2. Durability of Marking as per Cl. 6.2
3. Dimensions as per Cl. 7.1 to Cl. 7.3
4. Uniformity of Wall Thickness as per Cl. 7.4
5. Construction as per Cl. 8
6. Bending Test as per Cl. 9.2
7. Resistance to Heat as per Cl. 10
8. Resistance to Burning as per Cl. 11
|Gauges, measuring tape, vernier caliper, micrometer, bending device, bending aid, compression test apparatus, conditioning chamber, deep freezer, straps, ball pressure test apparatus, heating cabinet, Bunsen burner, high voltage breakdown test set, million mega ohm meter, stop watch, steel ball, impact test apparatus, straps
|9537 part 4
||Pliable self recovering conduits of insulating material
||1. Marking as per Cl. 6.1
2. Durability of Marking as per Cl. 6.3
3. Dimensions as per Cl. 7.1
4. Uniformity of Wall Thickness as per Cl. 7.2
5. Construction as per Cl. 8
6. Bending Test as per Cl. 9.2
7. Resistance to Burning as per Cl. 11
|Gauges, measuring tape, vernier caliper, micrometer, bending device, bending aid, compression test apparatus, conditioning chamber, deep freezer, straps, ball pressure test apparatus, heating cabinet, bunsen burner, high voltage breakdown test set, million mega ohm meter, stop watch, steel ball, impact test apparatus, straps
Valve regulated Lead Acid Batteries (VRLA) or Sealed Lead Acid (SLA)
ITC India pvt ltd is a NABL / BIS approved test lab and is testing all kinds of batteries as per IEC/ IS and EN standards. Get your batteries tested and enhance your business by getting a valid test report IS 15549. As the use of VRLA batteries is increasing in application like SLI, Motive power, Electric vehicle, they are definitely going to dominate others. For more information email email@example.com.
VRLA batteries are designed for UPS and for backup of telecommunication systems. This construction is designed to prevent electrolyte evaporation, spillage and gassing. Due to these features it has good life and is easy to maintain. The emission of hydrogen gas is used internally. These batteries are designed to retain and recombine these gases. The excess pressure is releases by a valve installed in VRLA battery.
Features and advantages of LEAD ACID batteries
- Low cost
- Can be recycled, reliable, robust
- Low self discharge
- As sealed no spillage of electrolyte
- No periodic topping of electrolyte
- Can be used vertically or horizontally.
- They occupy less space as can be placed over other battery in stack able steel racks.
- Better than conventional lead acid batteries.
- Danger of overheating while charging
- Cannot be charged quickly
- Cycle life 300 to 500 cycles
IS 15549 is a IS Standard for Sealed lead acid batteries and are tested in ITC India Pvt Ltd. Here is a list of tests that are performed on such batteries.
Type tests & acceptance test on VRLA batteries or sealed Lead acid batteries
Name of test
4.1 to 4.9 , 8.1
As per manufacturer drawing
Checking of dimensions
Test for C 10 capacity and voltage during discharge.
Test for C 1 capacity and voltage during discharge.
Ampere hour and watt hour efficiency test
Retention of charge test
Acid retention capability test on separator.
Wicking test on separators
Test on Vent seal operation
Test of oxygen recombination efficiency
Endurance life cycle test
Many explosions in mobile batteries, laptops, notebooks car batteries etc. are seen in past few years. There are many reported incidents due to battery explosion in mobile phone, laptops, cars, vape, Hover board and many more … What were the reasons of the explosion….
- Either Battery were made of cheaper material or recycled batteries were used
- Exposed to high temperature or humidity
How do Non compliance batteries effect User, supplier, manufacturer, importer?
Effect on User
- Risk to users safety
- resulted in injury
- less reliable
Effect on Manufacturer
- degrade the cost
- Degrade in market with no reputation
- Less sale /No sale
Hazards associated with Secondary batteries
- The Electrical & Chemical hazards
- Spillage: hazard linked to the corrosive and flammable properties of the electrolyte.
- Toxic or harmful Gas Emission like CO.
- Ejection of Parts
- High Voltage: a direct danger to humans due to exposure to high voltage or high current
- Loss of one (or more) of the battery service functions
To avoid above said incidents on Battery explosion, Compliance testing is necessary for all manufacturer, Importer and supplier. Secondary batteries or portable batteries or rechargeable batteries are to be tested as per IEC 62133 / IS 16046.
ITC India Pvt Ltd is leading service provider for all kinds of battery testing including IEC 62133 / IS 16046. All types of cells, protection circuit, battery management systems, battery packs ITC India is in the good list of clients. For any query please write to us at firstname.lastname@example.org.
ITC India Pvt Ltd is performing Lithium ion battery testing as per IEC / IS / UL/ EN Standards. If you are looking for a competent Laboratory that have ability to perform IEC 62133 testing and certification in a fast and professional way, please contact us! For more information write to email@example.com.
Lithium Ion Battery over Lead Acid battery
A lithium-ion battery is a power storage product in which lithium-ions move through an electrolyte from the negative electrode to the positive electrode during battery discharge and from the positive electrode to the negative electrode during charging. The electrochemically active materials in lithium-ion batteries are typically a lithium metal oxide for the cathode and a lithiated carbon for the anode. The electrolytes can be liquid, gel, polymer or ceramic. For liquid electrolytes, a thin micro-porous film provides electrical separation between the cathode and anode.
These batteries are more expensive than Lead acid battery but their lifetime per kWh is much lower when compared to lead acid batteries. The world is switching to Lithium ion batteries due to many advantages of it over lead acid batteries
- More energy efficient
- Less heavier
- Higher density
- Longer life cycle
- Environment friendly
- No maintenance
- Space efficient
- No leakage
Due to above said advantages, Lithium ion batteries become more dominant rechargeable battery. As per IEC 62133/ IS 16046 Cells and batteries shall be so designed and constructed that they are safe under conditions of both intended use and reasonably foreseeable misuse.
Many of the tests described are very similar to those described in UL and IEEE Standards. However, a few tests specified by IEC are unique like “free fall” test which requires multiple drops of a cell or battery on a concrete floor, an overcharge test for cells that requires protection from high-voltage overcharging.
List of test is as below…….
- Short circuit test
- Abnormal charging test
- Forced discharge test
- Crush test
- Shock test
- Vibration test
- Heating test
- Temperature cycling test
- Low pressure test
- Continues low-Rate Charging
- Molded case stress at high ambient temperature
- Free fall
IEC 60896 -11
STATIONARY LEAD – ACID BATTERIES
PART 11 : VENTED TYPES
GENERAL REQUIREMENTS AND METHODS OF TESTS
Itc India Pvt Ltd is a testing and certification company which is well known for its excellent track record for the best customer satisfaction. We have never compromised on the quality and the services that we provide to our customer. We believe in keeping the customers happy and providing those services at a very competent price. We have an excellent staffs who will guide you with their best ideas by keeping in constant touch with your company and informing about the market trends.
Vented Lead Acid Batteries: –
These vented lead acid batteries are also known as flooded or sealable or wet cell batteries. These batteries have terminals- negative terminal and positive terminal on their top or sides along with vent caps on their tops.
This segment of IEC standard is related to lead- acid cells and batteries those are particularly workable in fixed locations, which means that these batteries cannot be moved from one place to another. These batteries are permanently connected to the load and the d.c. power supply.
The designing of the cells and batteries shall be in such a way that they are able to withstand all the mechanical stresses during hauling, packing, handling etc.
Many other tests that comes under this standard are:-
Capacity (240 h, 120h , 48h, 10 h, 8 h, 3 h, 1 h, 0,5 h)
Suitability for floating battery operation
Endurance in cycles
Endurance in overcharge
Short-circuit current and internal resistance
Tests like endurance test are typically done so as ensure that the stationary cells and batteries are able to hold on against the load and be able to endure it for a long period of time. So, basically in endurance test charging and discharging cycles are done on the battery
Capacity test is done to ensure whatsoever is claimed by the manufacturer is available or not.
The other test like charge retention test helps us to see the strength of the charge present in battery if we put it in idle condition.
Some of the measuring instruments that are used while performing the other tests are voltmeter, ammeter, thermometer, hydrometers etc.
The basic scope of IEC 60601-1 is safety of patient, user and the equipment. Before launch of the Medical equipment in the market , It must be be tested as per the safety standard. All the accessories used with the equipment must be tested as per Particular standard IEC 60601-2-X series. It is also a mandatory standard for CE, UL and CSA marking.
Classification of Electro medical equipment:
There are 3 main classifications for Medical Equipment to indicate protection against Electric Shock
- Class 1 equipment relies on a protective earth.
- Class 2 equipment relies on double layers of insulation.
- Class 3 equipment is internally powered below the Safety Extra Low (SELV) level of 50 Vac
Why IEC 60601-1 is Important?
It ensure the safety of operator, patient and equipment itself. Below are some of the risks associated with such equipment.
- Extravagant currents result in an electrical shock to the user or patient, to overcome this hazard, safety standards are introduced .
- Exceptionally high currents passing through the body cause tissue heating.Cutting, Coagulation and Physiotherapy Ultrasound are controlled uses of this effect.
- High-frequency surgical equipment may burn the operator/ patient.
- Due to abnormal working of incubation,high frequency surgical equipment increase in temperature of Medical Equipment.
- An increase of respiratory via pressure caused by an abnormal working of ventilators.
Requirements of Electro medical equipment
- Robustness of the enclosure- It must be strong enough to be used normally without any mechanical damage.
- Earthing: It must be earthed properly so that there is no Leakage of current and must be electrical shock proof. Protective Earthing (PE) is a usual way to reduce electrical hazards by making a low resistance path in the case of a fault. Double insulated equipment does not require a safety earth because no mains parts are accessible.
- Single Fault Condition: It must work safe in normal condition and also remain safe during single fault condition .
Standards play a paramount role in product design and development. IEC 60601-1 is a series of technical standards for the safety and effectiveness of medical electrical equipment. The force of this standard is to require two level of protection to guard the patient and operator from any injury. It is recognized worldwide. This standard is of four parts:
- Base standard: General requirements for basic safety and essential performance. IEC 60601-1
- Collateral standards: Generally numbered as IEC 60601-1-) for example IEC 60601-1-11 General requirement for basic safety and essential performance collateral standard requirement for medical electrical equipment and medical electrical system used in the home health care environment.
- Particulate standards: They are numbered as IEC 60601-2-) for example IEC 60601-2-52 particular requirement for the basic safety and essential performance of medical beds.
- Performance standards: Generally numbered as IEC 60601-3- Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment.