TQMC has acquired wide Domain Knowledge and Experience. You can FREELY access it here and here

DISCLAIMER: This matter here is a guide only. For authentic and up-to-date information, please contact TQMC.

The DIRECTIVES and STANDARDS listed here may have been subsequently REVISED . You must refer to the CURRENT REVISION and AMENDMENTS if any.

Friday, May 7, 2010

CE Marking testing lab - ERTL

ERTL: A one stop solution for quality requirements
Usha Holla Mumbai

Diagnosis being the stepping stone for the success of a treatment procedure, it goes without saying that it needs to be done with utmost care and caution. Helping the physicians in this endeavour are a range of medical equipment. Therefore naturally these equipment should provide accurate results. This is made possible with calibration of equipment during their manufacturing. One of the premier institutions extending this service to medical equipment manufacturers and laboratories is Electronics Regional Test Laboratory (West), Mumbai.

Set up in 1985 under Standardisation, Testing & Quality Certification (STQC) Directorate, Ministry of Information Technology, Govt. of India, ERTL focuses on test, calibration, training and quality improvement services for varied industries including healthcare.

‘‘We carry out test and calibration of a wide range of medical electronic equipment for both domestic and export markets,’’ said K Murari, addl. director. The list of clients includes some big names from the industry viz. L&T, Siemens, Transasia, Metrolab, etc. Indian manufacturers are increasingly setting their eyes on the export market, especially Europe. ‘‘In the wake this development, there has been a surge in the demand for CE certification which is mandatory in Europe,’’ says Murari. Besides medical equipment manufacturers, pharmaceutical machinery manufacturers form another major clientele from the healthcare industry, he noted further. With its association with a number of national and international accreditation bodies, ERTL provides the specific certification requirements for various industries under one roof.

According to R C Thakur, addl. director, with frequent introduction of newer and more advanced equipment into the healthcare market, the need for testing these products has become all the more important. The testing facilities available for bio-medical equipment at ERTL include:

International safety analyser: This facility is to carry out testing of various electromedical units as per IEC-601-1. It can measure parameters like mains voltage, insulation resistance, earth continuity, earth leakage, enclosure leakage, patient leakage, patient auxilary current, mains on applied parts, etc.

Electrosurgery analyser: This facility can be utilised to test electrosurgery units in order to measure its output power, isolation to ground, dangerous low frequency currents, output waveforms, return electrode monitor systems, return fault systems, etc.

Defibrillator analyser: This facility can be used to verify the output characteristics of all defibrillators. The instrument measures the energy delivered by a defibrillator by simulating human body resistance and measuring the current through the resistance.

Multiparameter simulator: This can be used to simulate a Standard Heart Condition. The five digitally synthesised output simulation waveforms of the instrument can be continuously displayed either individually or in multiple combinations. The parameters which can be simulated by the instrument include 12 lead ECG, 4 Calibrated Static ECG rates, Normal Sinus, Pulse Train, Ventricular Fibrillation and Paced Rhythm, Calibrated Dynamic Arterial and PA Blood Pressure Waveforms, 13 Calibrated Static Pressures from -200 to 208 mm Hg, 4 Respiratory rates with 3 different Lead Selections, 3 Different Lead Selections, 3 Respiration Impedance Variation and Apnea, 3 Temperatures.

Incubators used to save the life of the infants need to be calibrated regularly because it is required to maintain specific temperature, humidity or oxygen flow inside the incubator. ERTL (W) has got the facility to calibrate temperature and humidity parameter with traceability to national standard and also in conformance to national/international requirement of medical association.

Besides testing and calibration, ERTL carries out extensive counselling, education and training activities. Seminars and workshops are held on a regular basis wherein participants are provided with information on varied aspects relating to quality enhancements at their set ups. ‘‘ We also extend our assistance in product development,’’ Murari noted. A prototype of a product is tested and studied. Then the company is instructed to start pilot production and ultimately a final analysis of the product is provided for mass production.

Despite having a wide range of facilities handled by competent personnel, ERTL’s services are not being sought after on a large scale by the healthcare industry, observes Murari. ‘‘Although there has been a rise in the demand for our services from this sector, we expect much better patronage,’’ he said further. And ERTL’s efficient network of four regional centres and 13 ETDCs all over the country should provide a good source of calibration and testing services for the industries, noted Abdul Moid, jt. director, Customer Service Cell.


No comments:

Post a Comment