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BIS Unveils New Standards for Medical Instruments and Traditional Herbs

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The Bureau of Indian Standards (BIS) has issued a new notice on 16 January 2025. This notice elaborates on new regulations for medical instruments and herbs of traditional medicine. It is updating the existing ones while introducing new standards. These updated standards will enable the safe use and proper functioning of medical instruments. BIS, operating under the aegis of the Department of Consumer Affairs, works toward quality products to protect every citizen from getting harmed or affected by harmful products.

Overview of new standards

The BIS introduces new rules effective from 10 January 2025. These consist of special brain surgery tools, forceps, cannulas, and standards for medicinal plants using traditional medicine. All of these would help in increasing safety effectiveness and compatibility with other modern methods of treatment. Thus, updates are in place to address issues related to the health sector with maximum safety and performance. 

Key highlights

  • Neurosurgical instruments: The notice comprises of neurosurgical instruments namely artery forceps and needle holders, for which standardization has been revised. Such revisions are very important so that the quality and reliability of instruments used in delicate surgical procedures are maintained.
  • Traditional medicine: New standards have been released for several medicinal plants where traditional medicine practices are applicable. This certainly indicates an awareness to blend the traditional knowledge with modern standards.
  • Concurrent validity: For those existing and older versions, this will stay effective until they officially withdraw their existing versions on the 10th of July 2025. Hence, for most manufacturers as well as healthcare professionals the overlap enables a smoother transition of this new requirement.

Details of established standards

The following table summarizes newly established standards plus the withdrawal counter as follows:

IS Number Title Date of Establishment Previous IS Number Date of Withdrawal
IS 8174: 2025 Neurosurgical Instruments — Forceps, Artery, Dandy’s Pattern — Shape and Dimensions (Second Revision) 10 January 2025 IS 8174: 1994
Neurosurgical Instruments — Forceps, Artery, Dandy’s Pattern — Shape and Dimensions (First Revision)
10 July 2025
 
IS 8695: 2025 Forceps, Dressing, Bayonet Shape, Gushing’s Pattern — Specification (First Revision) 10 January 2025 IS 8695: 1978
Specification for Forceps, Dressing, Bayonet Shape, Cushing’s Pattern
10 July 2025
 
IS 8696: 2025 Guide, Saw, De Martel’s Pattern — Specification (First Revision) 10 January 2025 IS 8696: 1978
Specification for Guide, Saw, De Martel’s Pattern
10 July 2025
 
IS/ISO 8980-3: 2022 Ophthalmic Optics — Uncut Finished Spectacle Lenses Part 3 Transmittance Specifications and Test Methods (First Revision) 10 January 2025 IS/ISO 8980-3: 2013
Ophthalmic Optics — Uncut Finished Spectacle Lenses Part 3 Transmittance Specifications and Test Methods
10 July 2025
 
IS 9911: 2025 Brain Cannula — Specification (First Revision) 10 January 2025 IS 9911: 1981
Specification for Cannula, Brain
10 July 2025
 
IS 13175: 2025 Neurosurgical Instruments — Needle Holder — Shape and Dimensions (First Revision) 10 January 2025 IS 13175: 1991 
Neurosurgical Instruments — Needle Holder — Shape and Dimensions
10 July 2025
 
IS 19096: 2025 ŪD-I-BALSĀN (Commiphora opobalsamum L. Engl.,) Wood for Use in Traditional Medicine — Specification 10 January 2025 - -
IS 19097: 2025 Chirchita (Achyranthus aspera L.) Dried Whole Herb for Use in Traditional Medicine — Specification 10 January 2025 - -
IS 19098: 2025 Sūranjān (Colchicum luteum Baker.) Dried corm for use in Traditional Medicine — Specification 10 January 2025 - -
IS 19102: 2025 Gul-i-Gā’ozabān (Borago officinalis L.) Flower for Use in Traditional Medicine — Specification 10 January 2025 - -

Implications for healthcare providers

These updates represent a promise of improving the health standards of India. Doctors and manufacturers have to follow these new specifications to continue to have quality assurance in the surgical procedure. The transitional period up to July is a grace period to get their practices right.

The recent notification of BIS is taking a major step forward to elevate standards in the medical fields of India by making the norms and specifications changeable and introducing new ones for surgical instruments as well as traditional medicines. BIS is thus concerned with providing assured safe health service by effectively giving proper treatments according to modern techniques. As the new changes begin to take shape, proper education and adaptation will be required of all those involved in medical service.

This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.

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Mahek Sancheti, BAJMC graduate with a deep passion for writing. As a content writer, video content creator, creative content creator, and scriptwriter, I bring stories to life through words and visuals. I honed my skills by working with a promi...

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