BIS Sets Standard For Medical Devices, Health Informatics-Related Products


New Delhi : The Bureau of Indian Standards (BIS) has notified Indian standards for various medical devices and health informatics-related products and processes as part of its efforts to set standards including for medication related processes and electronic prescriptions, among others.

BIS has fixed prices for various health informatics-related devices and infrastructure, including dynamic on-demand virtual private network for health information infrastructure (IS 17762:2022/ISO/TR 11636: 2009), provisions for health applications on mobile/smart devices (IS 17763:2022/ISO/TR 17522:2015), requirements for record of a dispense of a medicinal product (IS17764: 2022/ISO/TS 19293: 2018), personal health data generated on a daily basis (IS 17765: 2022/ISO/TR 21835: 2020), business requirements for a syntax to exchange structured dose information for medicinal products (IS 17767: 2022/ISO/TS 17251: 2016), requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (IS 17768: 2022/ISO/TS 22756: 2020), requirements for electronic prescriptions (IS 17769:2022/ISO 17523: 2016).

The other standards for the health informatics-related processes and products include medication management concepts and definitions (iS 17770: 2022/ISO/TR 20831: 2017), representation of categorical structures of terminology [CatStructure] (IS 17771: 2022/ISO 17115: 2020), guidelines on data protection to facilitate trans-border flows of personal health data (IS 17797: 2022/ISO 22857: 2013), and data elements and their metadata for describing structured clinical genomic sequence information in electronic health records (IS 17798: 2022/ISO/TS 20428: 2017). These standards have a date of establishment fixed as February 11, 2022, it added.

Through another  notification dated February 15, it has set IS 17709: 2022/ISO 11318:2002 standard for cardiac defibrillators – connector assembly DF-1 for implantable defibrillators, its dimensions and test requirements.

Under Cardiovascular Implants and Extracorporeal Systems, vascular device-drug combination products, as per Part 2 of local regulatory information, have been set with IS 17751 (Part 2): 2022/ISO/TR 12417-2 : 2017 standards.

For Underpad, a medical textiles product, it has set IS 17786: 2022 standards. All these standards were established as on February 10, 2022, said the notification.

It has also set the IS/ISO 10993-18: 2020 standard for biological evaluation of medical devices – chemical characterisation of medical device materials within a risk management process.


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