Last Updated on September 13, 2021 by The Health Master
The Bureau of Indian Standards (BIS), the national standards body of India, has specified the standards for four equipments related to anatomy and forensic sciences, under the Medical Equipment and Hospital Planning (MHD) of the Bureau based on standards of 2021.
The Bureau has published standards for
Paraffin Dispenser (IS 17533:2021),
Embalming Machine (IS 17534:2021),
Automated Grossing Station (IS 17535:2021) and
Basic requirements for tissue embedding station (IS 17543:2021), with their specifications.
So far, it has set standards for hundreds of medical equipment and related instruments between 23 categories in the sector.
116 in surgical instruments;
129 in orthopaedic instruments, implants and accessories;
65 in obstetric and gynaecological instruments and appliances;
82 in ear, nose and throat surgery instruments;
92 in ophthalmic instruments and applications;
56 in thoracic and cardiovascular surgery instruments;
51 in neurosurgery instruments implants and accessories;
190 in dentistry equipment;
32 in artificial limbs, rehabilitation appliances and equipment for the disabled;
59 in anaesthetic, resuscitation and allied equipment;
142 in hospital equipment and surgical disposals;
17 in veterinary hospital planning and surgical instruments;
43 in hospital planning;
99 in electro medical diagnostic imaging and radiotherapy equipment;
93 in health informatics;
35 in biological evaluation of in vitro diagnostic medical devices;
2 in medical biotechnology and nanotechnology, apart from the anatomy and forensic sciences equipment.
There are 22 technical committees, two sub committees and four panels to set standards for the MHD segment in the BIS.
Besides the equipment for which standards have been set, the Bureau is also working on proposals for standards for various facilities and equipment including space and equipment for a veterinary hospital along with adjacent post-mortem room, processing of health care products – information to be provided by the medical devices manufacturer for the process of medical devices (for which the Bureau says that standard exists corresponding to the proposal), requirements for basic safety and essential performance of medical electrical equipment – insufflator and irrigation pump, hospital pneumatic tube system, cyber security in healthcare, among others which are at various stages of setting up standards and implementation.
BIS is involved in various activities including standard formulation, product certification scheme, compulsory registration scheme, foreign manufacturers certification scheme, Hall marking scheme, laboratory services, laboratory recognition scheme, sale of Indian standards, consumer affairs activities, among others.