**Executive Summary**
The Bureau of Indian Standards (BIS) has notified the establishment and revision of 13 Indian Standards across medical, surgical, and technical sectors, effective March 30, 2026. Several older standards for medical instruments will remain in force concurrently until their scheduled withdrawal on September 30, 2026. This notification, issued under the BIS Rules 2018, aims to update specifications for surgical tools, laboratory glassware, and reference material production.
**Key Points / Main Content**
**Establishment and Revision of Standards**
* **Establishment Date:** 13 Indian Standards were officially established on March 30, 2026.
* **Transition Period:** For standards being revised, the previous versions will coexist with the new versions until September 30, 2026.
**Medical and Surgical Instruments (Revised Standards)**
* **IS 6510: 2026:** Specifications for suction-type endometrial biopsy curettes (First Revision).
* **IS 6436: 2026:** Specifications for thoracic surgery instruments, specifically adult-sized rib spreaders in Finochietto’s pattern (Second Revision).
* **IS 6589: 2026:** Dimensional and shape requirements for gynaecological forceps and uterine dressing in Bozemann’s pattern (Second Revision).
* **IS 7080 (Part 1): 2026:** Specifications for manually operated MTP suction apparatus (Third Revision).
* **IS 7432: 2026:** Requirements for myomectomy clamps in Bonney’s pattern (First Revision).
* **IS 10156: 2026:** Specifications for intra-uterine cannulas used in hysterosalpingography (First Revision).
**Laboratory and Electrical Equipment**
* **IS 7039: 2026:** Specifications for medical laboratory glassware, specifically culture tubes with screw caps (First Revision).
* **IS 16463 (Part 32): 2026:** Adoption of IEC 61643-32:2017 for low-voltage surge protective devices connected to the DC side of photovoltaic installations.
**Reference Materials (New Standards)**
* **IS 19804 to IS 19808 (2026):** A series of new standards (aligned with ISO 33401 to 33407) covering the production of pure organic substance certified reference materials, characterization of homogeneity and stability, and requirements for labels and documentation.
**Impact Analysis**
**Manufacturers of Medical and Surgical Instruments**
**Impact**
Manufacturers of biopsy curettes, rib spreaders, gynaecological forceps, and MTP suction apparatus must comply with updated technical specifications and revisions.
**Action Required**
Update manufacturing processes to align with 2026 revisions and ensure all products meet the new standards before the older versions are withdrawn on September 30, 2026.
**Photovoltaic System Developers and Electrical Safety Engineers**
**Impact**
The introduction of IS 16463 (Part 32) provides new selection and application principles for surge protective devices in photovoltaic installations.
**Action Required**
Incorporate the new standards into the design and installation of DC-side surge protection for solar power systems.
**Laboratories and Producers of Reference Materials**
**Impact**
Laboratories are now subject to formalized guidelines regarding the characterization, qualitative properties, and labeling of reference materials.
**Action Required**
Review and adopt the requirements of IS 19804 through IS 19808 to ensure compliance with international quality standards for reference materials.
**Medical Laboratories**
**Impact**
Revised specifications for culture tubes and uterine cannulas may affect procurement and quality control protocols.
**Action Required**
Verify that all newly purchased culture tubes and intra-uterine cannulas meet the revised IS 7039 and IS 10156 specifications.
Key Entities Referenced
Bureau of Indian Standards (BIS): The national standards body of India responsible for notifying the establishment and withdrawal of the technical standards listed in the gazette.
Bureau of Indian Standards Rules, 2018: The governing regulatory framework, specifically Rule 15(1), under which the notification of Indian Standards is processed.
Indian Standards (IS): The specific technical specifications (such as IS 6510, IS 6436, and IS 7039) established or revised to regulate the quality and safety of medical instruments and industrial components.
Department of Consumer Affairs: The central government department under which the Bureau of Indian Standards operates and exercises its authority.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-16042026-271839
xxxGIDHxxx
CG-DL-E-16042026-271839
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग III—खण् ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 263] नई दिल्ली, सोमिार, अप्रैल 13, 2026/चत्रै 23, 1948 र् 22, 1947
No. 263] NEW DELHI, MONDAY, APRIL 13, 2026/CHAITRA 23, 1948 s 1947
भारतीय मानक ब्य रू ो
(उपभोक्त ा मामल ेजिभाग)
अजधसचू ना
नई दिल्ली, 1 अप्रलै , 2026
सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (1518).— भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के
उपजनयम (1) के अनुसरण में भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के जििरण इसमें संलग्न
अनूसूची के जद्वतीय स्ट्तंभ में दिये गये हैं, तीसरे स्ट्तंभ में इंजगत जतजि को स्ट्िाजपत हो गये ह|ैं चौिे स्ट्तंभ में दिये गये मानकों के जििरण,
यदि कोई हो तो िे भी साि-साि लागू रहगें े िब तक िे पााँचिें स्ट्तंभ में इंजगत जतजि को िापस जलए िाने ह|ैं
अनसु चू ी
क्रम स्ट्िाजपत भारतीय मानकों की संख्या, िर्भ तिा प्रजतस्ट्िापन भारतीय मानकों, यदि िापस जलए िापस होने की
स.ं िीर्भक जतजि िाने ह,ैं की संख्या, िर्भ तिा जतजि
िीर्भक
(1) (2) (3) (4) (5)
आई एस 6510 : 2026 30 माचभ 2026 आई एस 6510 – 1971 30 जसतंबर
1 सक्िन प्रकार का एंडोमेट्ररयल बायोप्सी क्यूरेट क्यूरेट, एंडोमेट्ररयल बायोप्सी, 2026
— जिजिजि सक्िन प्रकार के जलए जिजिजि
(पहला पुनरीक्षण)
2682 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
2 आई एस 6436 : 2026 30 माचभ 2026 आई एस 6436 : 1989 30 जसतंबर
िक्ष िल्य जचदकत्सा उपकरण — पसली छाती संबन्धी िल्यदक्रया उपकरण 2026
जिस्ट्तारक, दिनोजचएटो स्ट्िरूप, व्यस्ट्क माप — — पसली स्ट्प्रैडर, दिनोजिएटो
जिजिजि नमूने का, व्यस्ट्क साइि —
(िसू रा पुनरीक्षण) जिजिजि
(पहला पुनरीक्षण)
3 आई एस 6589 : 2026 30 माचभ 2026 आई एस 6589 : 1992 30 जसतंबर
गयनेकोलॉजिकल उपकरण — िोसेप्स, गभाभिय स्त्रीरोग सम्बंधी — गभाभिय की 2026
ड्रेससंग, बोज़मैन पैटनभ — आकार और पट्ररमाण मरहमपट्टी के जलए बोिमैन नमूने
(िसू रा पुनरीक्षण) की जचमटी — आकृजत एिं आयाम
(पहला पुनरीक्षण)
4 आई एस 7039 : 2026 30 माचभ 2026 आई एस 7039 – 1973 30 जसतंबर
जचदकत्सा प्रयोगिाला हते ु कााँच सामान — ट्यूब, कल्चर, स्ट्क्रू कैप के जलए 2026
संिधनभ के जलए नजलका एंि पेंच िाला ढक्कन — जिजिजि
जिजिजि
(पहला पुनरीक्षण)
5 आई एस 7080 (भाग 1) : 2026 30 माचभ 2026 आई एस 7080 (भाग 1) : 30 जसतंबर
एम.टी.पी. सखंचाि उपकरण — जिजिजि 1992 2026
भाग 1 मानिचाजलत एम.टी.पी. चूर्ण उपकरण —
(तीसरा पुनरीक्षण) जिजिजि
भाग 1 मानिचाजलत
(िसू रा पुनरीक्षण)
6 आई एस 7432 : 2026 30 माचभ 2026 आई एस 7432 – 1974 30 जसतंबर
जमओमेक्टमी क्लैम्प, बोनीज़ पैटनभ — जिजिजि क्लैम्प, जमओमेक्टमी, बोनीज़ 2026
(पहला पुनरीक्षण) पैटनभ के जलए जिजिजि
7 आई एस 10156 : 2026 30 माचभ 2026 आई एस 10156 : 1982 30 जसतंबर
कैनुला, अंतगभभाभियी, जहस्ट्टेरोसलसपंगोग्रािी — कैनुला, अंतगभभाभियी, 2026
जिजिजि (पहला पुनरीक्षण) जहस्ट्टेरोसलसपंगोग्रािी के जलए
जिजिजि
8 आई एस 16463 (भाग 32) : 2026 30 माचभ 2026 लाग ूनहीं लाग ूनहीं
आई ई सी 61643-32 : 2017
जनम्न-िोल्टेि सिभ प्रोटेजक्टि युजियााँ
भाग 32 िोटोिोजल्टक उपकरणों के डीसी पक्ष से
संयोजित होने िाले सिभ प्रोटेजक्टि युजियााँ —
चयन और अनुप्रयोग जसद्ांत
9 आई एस 19804 : 2026 30 माचभ 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 33406 : 2024[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
गुणात्मक जििेर्ताओं िाली संिभभ सामग्री के
उत्पािन हते ु िजृिकोण
10 आई एस 19805 : 2026 30 माचभ 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 33407 : 2024
िुद् काबभजनक पिािभ प्रमाजणत संिभभ सामग्री के
उत्पािन — मागभििभन
11 आई एस 19806 : 2026 30 माचभ 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 33405 : 2024
संिभभ सामग्री — समरूपता तिा जस्ट्िरता के
जनधाभरण और मूल्यांकन हते ु पद्जतयााँ
12
आई एस 19807 : 2026 30 माचभ 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 33401 : 2024
संिभभ सामग्री — प्रमाण पत्रों, लेबलों तिा संलग्न
प्रलेखन की जिर्य-िस्ट्तु
13 आई एस 19808 : 2026 30 माचभ 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 33403 : 2024
संिभभ सामग्री — उपयोग हते ु अपेक्षाएाँ और
जसफाट्ररि ें
जनिात सुल्ताना हक़, िैज्ञाजनक िी एिं उप महाजनिेिक (प्रयोगिालाएाँ)
[जिज्ञापन-III/4/असा./32/2026-27]
BUREAU OF INDIAN STANDARDS
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 1st April, 2026
Ref: HQ-PUB013/1/2020-PUB-BIS (1518).— In pursuance of Sub-rule (1) of Rule (15) of the Bureau of
Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that Indian standards, particulars of
which are given in the second column of the schedule hereto annexed have been established on the date indicated
against it in third column. The particulars of the standards, if any which are given in the fourth column shall also
remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column;
SCHEDULE
Sl. No., Year & Title of the Indian Date of No. , Year & Title of the Date of
No. Standards Established Establishment Indian Standards to be Withdrawal
Withdrawn, if any
(1) (2) (3) (4) (5)
1 IS 6510 : 2026 30 March 2026 IS 6510 – 1971 30 September
Suction Type Endometrial Biopsy Specification for Curette, 2026
Curette — Specification Endometrial Biopsy, Suction
(First Revision) Type4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
2 IS 6436 : 2026 30 March 2026 IS 6436 : 1989 30 September
Thoracic Surgery Instruments Thoracic Surgery 2026
— Rib Spreader, Instruments — Rib
Finochietto’s Pattern, Adult Spreader, Finochietto’s
Size — Specification Pattern, Adult Size —
(Second Revision) Specification
(First Revision)
3 IS 6589 : 2026 30 March 2026 IS 6589 : 1992 30 September
Gynaecological Instruments Gynaecological Instruments 2026
— Forceps, Uterine Dressing, — Forceps, Uterine Dressing,
Bozemann’s Pattern — Shape and Bozemann’s Pattern — Shape
Dimensions and Dimensions
(Second Revision) (First Revision)
4 IS 7039 : 2026 30 March 2026 IS 7039 – 1973 30 September
Medical Laboratory Glassware — Specification for Tube, Culture, 2026
Culture Tube with Screw Cap — Screw Cap
Specification
(First Revision)
5 IS 7080 (Part 1) : 2026 30 March 2026 IS 7080 (Part 1) : 1992 30 September
MTP Suction Apparatus — MTP Suction Apparatus — 2026
Specification Specification
Part 1 Manually Operated Part 1 Manually Operated
(Third Revision) (Second Revision)
6 IS 7432 : 2026 30 March 2026 IS 7432 – 1974 30 September
Myomectomy Clamp, Bonney’s Specification for Clamp, 2026
Pattern — Specification Myomectomy, Bonney’s Pattern
(First Revision)
7 IS 10156 : 2026 30 March 2026 IS 10156 – 1982 30 September
Cannula, Intra-Uterine, Specification for Cannula Intra- 2026
Hysterosalpingography — Uterine, Hysterosalpingography
Specification
(First Revision)
8 IS 16463 (Part 32) : 2026 30 March 2026 NA NA
IEC 61643-32 : 2017
Low-Voltage Surge Protective
Devices
Part 32 Surge Protective Devices
Connected to the d.c. Side of
Photovoltaic Installations —
Selection and Application
Principles
9 IS 19804 : 2026 30 March 2026 NA NA
ISO 33406 : 2024
Approaches for the Production of
Reference Materials with
Qualitative Properties[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5
10 IS 19805 : 2026 30 March 2026 NA NA
ISO 33407 : 2024
Production of Pure Organic
Substance Certified Reference
Materials — Guidance
11 IS 19806 : 2026 30 March 2026 NA NA
ISO 33405 : 2024
Reference Materials — Approaches
for Characterization and
Assessment of Homogeneity and
Stability
12 IS 19807 : 2026 30 March 2026 NA NA
ISO 33401 : 2024
Reference Materials — Contents of
Certificates, Labels and
Accompanying Documentation
13 IS 19808 : 2026 30 March 2026 NA NA
ISO 33403 : 2024
Reference Materials —
Requirements and
Recommendations for Use
NISHAT SULTANA HAQUE, Scientist G & DDG (Labs)
[ADVT.-III/4/Exty./32/2026-27]
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.