| 1. |
IS 17625 (Part 2/Sec 69) : 2021
ISO 80601-2-69 : 2020
|
Oxygen Concentrator |
Oxygen concentrator supplies oxygen enriched air produced from room air anddelivered to patients requiring oxygen therapy. This standard is intended for use in home healthcare environment for single patient with acute or chronic respiratory disorders and is applicable to a transit-operable and non-transit- operable oxygen concentrator. |
View IS Detail
|
| 2. |
IS/ISO 80601-2-61) : 2017
|
Pulse Oximeter equipment |
The Pulse oximeter equipment includes the arterial oxygen haemoglobin saturation and pulse rate of patients used in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. |
View IS Detail
|
| 3. |
IS/ISO 15197 : 2013
Reviewed In : 2020 |
Blood Glucose Monitoring System |
This product is intended for self-measurement by lay persons for management of diabetes mellitus. specifies the design verification procedures and performance validation requirements of In-vitro glucose monitoring systems that measure glucose concentration in capillary blood samples |
View IS Detail
|
| 4. |
IS 13450 (Part 2/Sec 16) : 2019
IEC 60601-2-2_2017
|
Haemodialysis,Haemodiafiltration and Haemofiltration equipment |
Hemodialysis is a procedure in which the dialysis machine consisting of dialyzer and dialysate is used to remove the waste from the body |
View IS Detail
|
| 5. |
IS/ISO 24234 : 2015
Reviewed In : 2022 |
Dental amalgam |
Dental amalgam is a mixture of metals, consisting of liquid mercury and a powdered alloy composed of silver, tin, and copper. This mixture is used to fill cavities caused by tooth decay. |
View IS Detail
|
| 6. |
IS 11979 : 1987
Reviewed In : 2017 |
Intraocular lenses |
Intraocular lenses are widely used in cataract surgeries to replace the cataractous natural lens of the eye. It is also used for correcting errors in near-sighted, far-sighted, and astigmatic eyes using phakic intraocular lens which is implanted without removing the patient's natural crystalline lens |
View IS Detail
|
| 7. |
IS 13009 : 2021
ISO 19351:2019
|
Fallopian rings |
These devices are elastic bands made from medical grade silicone that are implanted bilaterally using a laparoscopic surgical procedure. Standard specifies the minimum requirements and test methods for fallopian rings used for tubal occlusion in women for permanent contraception |
View IS Detail
|
| 8. |
IS/ISO 14708-2 : 2019
|
Cardiac pacemakers |
Pacemaker is a implantable device which generates electrical impulses to control the heart rate. This Standard specifies the requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. |
View IS Detail
|
| 9. |
IS/IEC 80601-2-30) : 2018
|
Automated non - invasive sphygmomanometers |
The Automated non-invasive sphygmomanometer measures the blood pressure using the pressure cuff without the arterial punture. This standard provides the general requirements, essential performance requirements, requirements of protection against the electrical hazards and mechanical hazards. |
View IS Detail
|
| 10. |
IS 13450 (Part 2/Sec 18) : 2014
IEC 60601-2-18 : 2009
Reviewed In : 2019 |
Endoscopic equipment |
Endoscopic equipment are those which by viewing means are introduced into the body cavity through natural or surgical means for examination, diagnosis or therapy. |
View IS Detail
|
| 11. |
IS 13450 (Part 2/Sec 54) : 2016
IEC 60601-2-54:2009
Reviewed In : 2021 |
X-ray equipment for radiography and radioscopy |
Radiography and Radioscopy are techniques used for visualization of internal body parts using x-ray machine and capturing static and dynamic structures respectively |
View IS Detail
|
| 12. |
IS 13450 (Part 2/Sec 44) : 2016
IEC 60601-2-44:2009
Reviewed In : 2021 |
X-ray equipment for computed tomography |
Computed Tomography is a computerized x-ray imaging procedure in which a narrow beam of x-rays is aimed at a patient and quickly rotated around the body, producing signals that are processed by the computer to generate cross-sectional images or slices. These slices are called tomographic images and can give a clinician more detailed information than conventional x-rays. |
View IS Detail
|
| 13. |
IS 13450 (Part 2/Sec 33) : 2018
IEC 60601-2-33:2010
Reviewed In : 2023 |
Magnetic resonance equipment |
Magnetic resonance imaging (MRI) is a non-invasive medical imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues in the body. |
View IS Detail
|
| 14. |
IS/ISO 14708-7 : 2013
|
Cochlear implant |
A cochlear implant system or auditory brainstem implant system is an active implantable medical device. The implant system is designed to restore hearing via electrical stimulation of the auditory pathways. The processed acoustic information is converted to electrical stimulation signals which are delivered via the electrodes for providing the sense of hearing |
View IS Detail
|
| 15. |
IS/IEC 80601-2-49) : 2018
|
Multifunction patient monitors |
Multifunction patient monitor is a medical device that monitors a single patient's physiological parameters like electrocardiography, non-invasive blood pressure, invasive blood pressure, pulse oximetry, temperature, electroencephalography and respiratory gas. The Parameters are either displayed or remotely reported. It also has warning systems like alarm when the parameters enter the abnormal range. |
View IS Detail
|
| 16. |
IS/IEC 80601-2-58) : 2016
|
Lens removal devices and vitrectomy devices |
Lens removal devices and Vitectomy devices are used widely in ophthalmology to perform anterior-segment and posterior-segment surgery on the human eye. Lens removal devices hold mechanisms like phacofragmentation, liquefication and laser fragmentation for removing the unwanted lens tissue. Vitectomy devices are used in surgical procedure to remove the vitreous humour, lens tissue and other material of the eye. |
View IS Detail
|
| 17. |
IS 13450 (Part 2/Sec 37) : 2019
IEC 60601-2-37_2007
|
Ultrasonic medical diagnostic and monitoring |
Ultrasonic medical diagnostic equipment is a medical electrical equipment which is used for medical examination |
View IS Detail
|
| 18. |
IS 13450 (Part 2/Sec 24) : 2019
IEC 60601-2-24 : 201
|
Infusion pumps |
Infusion pump is a medical device which regulates the flow of fluid into the patient in a controlled manner using the pump. This Standard specifies particular requirements for providing protection against electrical, mechanical, radiation, temperature and electromagnetic compatibility of the Infusion pump. |
View IS Detail
|
| 19. |
IS 13450 (Part 2/Sec 25) : 2018
IEC 60601-2-25:2011 Medical electrical equipment - Part 2 Particular requirements for the basic safe
Reviewed In : 2023 |
Electrocardiographs |
Electrocardiograph is a medical device including the leads and the electrodes intended for producing the electrocardiogram for diagnostic purpose. |
View IS Detail
|
| 20. |
IS/ISO 80601-2-12) : 2011
|
Critical Care Ventilators |
Ventilators are devices which when connected to the patient provide or augment the ventilation of the lungs. |
View IS Detail
|
| 21. |
IS/ISO 80601-2-56) : 2017
|
Clinical thermometers |
The purpose of Clinical thermometer is to access the body temperature, which is a vital sign in accessing the overall health of the patient. |
View IS Detail
|
| 22. |
IS 13450 (Part 2/Sec 19) : 2023
IEC 60601-2-19 : 2009
|
Infant Incubators |
Infant Incubator is a medical device which provides controlled environment for the development of the vital organs. This standard specifies the particular requirements for providing protection against electrical, mechanical, radiation, temperature and electromagnetic compatibility of the infant incubator |
View IS Detail
|
| 23. |
IS 13450 (Part 2/Sec 21) : 2023
IEC 60601-2-21:2020
|
Infant Radiant Warmers |
Infant radiant warmer is an electrically powered device intended to maintain the thermal balance of the infant. This standard specifies the particular requirements for providing protection against electrical, mechanical, radiation, temperature and electromagnetic compatibility of the infant radiant warmer. |
View IS Detail
|
| 24. |
IS 13450 (Part 2/Sec 12) : 2023
ISO 80601-2-12:2020
|
Critical Care Ventilators |
Critical Care Ventilator is a device used to provide ventilatory support for patients who cannot breathe on their own or who require assistance to maintain adequate ventilation. This standard specifies the particular requirements for providing protection against electrical, mechanical, radiation, temperature, hazardous output and electromagnetic compatibility of the critical care ventilator. |
View IS Detail
|
| 25. |
IS 13450 (Part 2/Sec 84) : 2023
ISO 80601-2-84:2020
|
Ventilators For Emergency Medical Services Environment |
EMS Ventilators are devices designed to provide Emergency medical service and ventilatory support during transport. This standard specifies the particular requirements for providing protection against electrical, mechanical, radiation, temperature, hazardous output and electromagnetic compatibility of EMS Ventilators |
View IS Detail
|
| 26. |
IS 17932 (Part 1) : 2023
|
Biological Evaluation of Medical Devices |
A medical device or material that comes in contact with the patient's body has to perform its intended function without resulting in any adverse effect to a patient. The medical devices are subject to biological evaluation and biocompatibility testing to evaluate the interaction between a device and tissue, cells or body fluids of the patient. This standard specifies the biocompatibility assessment process to protect patient from potential biological risks. |
View IS Detail
|
| 27. |
IS 13450 (Part 2/Sec 70) : 2022
ISO 80601-2-70:2020
|
Sleep Apnoea Breathing Therapy Equipment |
Sleep apnoea breathing therapy equipment is a device which delivers therapeutic breathing pressure to the patient intended to treat obstructive sleep apnoea by keeping the upper airways open. This standard specifies the particular requirements for providing protection against electrical, mechanical, radiation, temperature, hazardous output and electromagnetic compatibility of Sleep Apnoea Breathing Therapy Equipment. |
View IS Detail
|
| 28. |
IS 17718 : 2022
|
α-Amylase CNP-G3 Liquid Stable Clinical Chemistry Reagents/ Kit |
Amylase is an enzyme secreted by the salivary gland and pancreas, to digest carbohydrates. It is predominantly found in saliva and pancreatic tissue. The amount of amylase is normally in small amounts in the blood and urine. In case of, acute pancreatitis and pancreatic duct obstruction, the level of serum and the urine amylase increases significantly. The quantitative determination of alpha amylase in the human blood is a useful diagnostic tool in identifying the pathological condition. This standard gives the standard testing procedure for the performance evaluation of CNPG3 method for the estimation of alpha – amylase in human blood.
|
View IS Detail
|
| 29. |
IS/ISO 25539-1 : 2017
|
Endovascular Prostheses |
Endovascular prostheses are partially or completely placed within a blood vessel, or vascular conduit to form an internal bypass or shunt between sections of the vascular system, delivered and deployed using a delivery system. This standard specifies the requirements for the evaluation, design attributes, material composition, sterilization and packaging of the endovascular prostheses. |
View IS Detail
|
| 30. |
IS 17841 (Part 2) : 2022
ISO 25539:2020
|
Vascular Stents |
Vascular Stent is balloon-expandable or self-expanding implant intended to maintain or restore vessel patency or function. This Standard specifies the requirements for the evaluation, design attributes, material composition, sterilization and packaging of the vascular stent. |
View IS Detail
|
| 31. |
IS 17840 (Part 1) : 2022
5840-1:2021
|
Cardiac Valve Prostheses |
Cardiac Valve Prostheses is a device used to replace the function of a native valve of the heart. This Standard is applicable to heart valve substitutes intended for implantation and provides general requirements, device description, invitro assessment and preclinical in vivo assessment procedures. |
View IS Detail
|
| 32. |
IS/ISO 23409 : 2015
Reviewed In : 2020 |
Male Condoms |
This Standard specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections
|
View IS Detail
|
| 33. |
IS 17962 : 2022
ISO 25841:2017
|
Female Condoms |
A female condom is a sheath that completely lines the vaginal canal and is designed to be retained in the vagina during sexual intercourse and after withdrawal of the penis to prevent pregnancy and transmission of sexually transmitted infections (STIs). This Standard specifies the minimum requirements and the test methods applicable to female condoms. |
View IS Detail
|
| 34. |
IS 17898 : 2023
ISO 15190:2020
|
Medical Laboratories |
The clinical laboratory is increasingly integrated with patient care, assisting diagnosis, monitoring therapies and predicting clinical outcomes. This standard specifies the requirements for safe practices in the medical laboratory. It includes the safety design requirements, safety management program, hazard identification and risk assessment procedure.
|
View IS Detail
|
| 35. |
IS 18244 : 2023
ISO 21387:2020
|
Sterilization Of Medical Devices |
This Standard provides guidance on the requirements of parametric release used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e., load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process. |
View IS Detail
|
| 36. |
IS 17750 (Part 6) : 2022
ISO 14708-6:2019
|
Active Implantable Medical Devices |
This Standard specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia. |
View IS Detail
|
| 37. |
IS 17840 (Part 2) : 2022
5840-2:2021
|
Surgically Implanted Heart Valve Substitute |
This Standard has been prepared for surgical heart valve substitutes with emphasis on providing guidance for in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro, preclinical in vivo, and clinical evaluations and labelling and packaging of the device. This process is intended to clarify the required procedures prior to market release and to enable prompt identification and management of any subsequent issues. |
View IS Detail
|
| 38. |
IS 17840 (Part 3) : 2022
ISO 5840-3:2021
|
Heart Valve Substitutes Implanted by Transcatheter Techniques |
This Standard is applicable to all devices intended for implantation as a transcatheter heart valve substitute. This Standard establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute |
View IS Detail
|
| 39. |
IS 18245 : 2023
ISO/TS 16775:2021
|
Packaging For Terminally Sterilized Medical Devices |
This standard provides guidance for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. It provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices. |
View IS Detail
|