BIS notifies new standard for these Medical Devices

Devices which treat hearing impairment via means other than electrical stimulation are not covered in this document

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BIS

Last Updated on January 14, 2022 by The Health Master

The Bureau of Indian Standards (BIS) has notified the establishment of the revised ISO standard for active implantable medical devices, Part 7, with particular requirements for cochlear and auditory brainstem implant systems, from the date of December 27, 2021.

According to the notification, IS 7750 (Part 7) : 2021/ISO 14708-7 : 2019 has been established as the standard for Implants for Surgery – Active Implantable Medical Devices Part 7 Particular Requirements for Cochlear and Auditory Brainstem Implant Systems (First Revision), from December 27, 2021.

The IS/ISO 14708-7 established in 2013, for the same would remain valid for one more year, but will be withdrawn on December 26, 2022, one year from the establishment of the new ISO standard, according to a notification issued by BIS, under the Department of Consumer Affairs.

It may be noted that the international standard setting organization ISO published the revised version of the 2013 standards in December 2019 and withdrew the former earlier.

The 2019 document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment thru electric stimulation of the auditory pathways.

Devices which treat hearing impairment via means other than electrical stimulation are not covered in this document,” says the ISO website. However, it is applicable to non-implantable parts and accessories of the devices. It also specifies the tests to be carried out on samples of a device to show compliance.

“A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories.

Not all of these parts are required to be either partially or totally implantable, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part,” added the ISO specification of the standard.

Copies of the IS 17750 (Part 7): 2021/ISO 14708 – 7: 2019 standards are available for sale at the BIS head office in New Delhi, regional offices in Kolkata, Chandigarh, Chennai, and Mumbai, and across its 22 branch offices in the country, said the notification.

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