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Astute Labs Pvt Ltd | Medical
Laboratory Equipments Testing
Bio-compatibility / Toxicology Tests
Accelerated Ageing Study
Environmental and Surface Monitoring
Medical Tesing EN 60601-1
Astute labs Pvt Ltd offers services of testing the medical devices as per the latest harmonised standards in EN 60601 series.
The standard focus on general requirements of basic electrical safety, mechanical safety and physical safety along with effectiveness of the medical devices.
EN 60601-1 is an "essential safety standard' for any active medical device manufacturer and is harmonised under the Medical Devices Directive (MDD), thereby offering a presumption of conformity with many of the Essential Requirements (ERs). However, on 1 June 2012 the second edition of this standard loses its harmonised status and only the third edition will remain harmonised.
Therefore manufacturers need to ensure they maintain compliance with the medical device directive for new and existing products that are placed on the market after 1 June 2012, after this date manufacturers must be able to demonstrate that all devices they are placing on the European market continue to comply with the ERs of the MDD. The solutions used must comply with the state of the art as required by ER. EN 60601-1 third edition can be used or the second edition if an applicable second edition Particular Standard, that remains harmonised, is also applied. If an alternative solution is used then it will be compared with the third edition and an equivalent level or safety and performance would need to be demonstrated.
EN 60601-1-2:2007 /AC:2010
The tests which are focusing on the electromagnetic compatibility and immunity of the medical device, please contact us for the details about number of tests applicable to your product.
specification of IMMUNITY TEST LEVELS based on the reasonably foreseeable maximum level of ELECTROMAGNETIC DISTURBANCES in the environments of INTENDED USE
Astute labs Pvt Ltd offers the testing services based on the following particular standards which are harmonised by medical device directive
EN 60601-2-1:1998 /A1:2002
EN 60601-2-3:1993 /A1:1998
Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
EN 60601-2-8:1997 /A1:1997
Medical electrical equipment -- Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
EN 60601-2-10:2000 /A1:2001
Medical electrical equipment -- Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
EN 60601-2-11:1997 /A1:2004
Medical electrical equipment -- Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
EN 60601-2-13:2006 /A1:2007
EN 60601-2-16:1998 /AC:1999
Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Medical electrical equipment -- Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
EN 60601-2-18:1996 /A1:2000
Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment
Medical electrical equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
Medical electrical equipment -- Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
Medical electrical equipment -- Part 2-24: Particular requirements for the safety of infusion pumps and controllers
EN 60601-2-25:1995 /A1:1999
Medical electrical equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs
Medical electrical equipment -- Part 2-26: Particular requirements for the safety of electroencephalographs
EN 60601-2-27:2006 /AC:2006
Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
Medical electrical equipment -- Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
EN 60601-2-33:2002/ A2:2008/AC:2008
Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
Medical electrical equipment -- Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
EN 60601-2-38:1996 /A1:2000
Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds
Medical electrical equipment -- Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
Medical electrical equipment -- Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
Medical electrical equipment -- Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
Medical electrical equipment -- Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
Medical electrical equipment -- Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
Medical electrical equipment -- Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
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