**Executive Summary**
This notification issued by the Bureau of Indian Standards (BIS) announces the establishment of nine new and revised Indian Standards effective from 10 March 2026. The document, published under the BIS Rules 2018, details technical specifications for ophthalmic instruments, medical injection systems, and digital media labeling. For revised standards, a concurrent validity period is provided until the previous versions are officially withdrawn on 10 September 2026.
**Key Points / Main Content**
**Establishment of Ophthalmic Instrument Standards**
* **IS 8181 : 2026:** Establishes revised specifications for Iris Repositors, replacing the 1976 version.
* **IS 8772 : 2026:** Establishes the second revision for Barraquer’s pattern eye needle holders, replacing the 1985 version.
* **IS 9378 : 2026:** Establishes the second revision for Castroviejo’s pattern eye speculums, replacing the 1987 version.
**New Medical and Pharmaceutical Standards**
* **Needle-Based Injection Systems (IS 19282):** Parts 3 and 7 establish requirements for integrated fluid paths and accessibility features for persons with visual impairments.
* **Prefilled Syringes (IS 19329):** Part 6 specifies requirements for plastic barrels for injectables and sterilized subassembled syringes.
* **Elastomeric Parts (IS 19611):** Part 5 outlines functional requirements and testing for elastomeric components used in parenterals and pharmaceutical devices.
* **Infusion and Injection Vials (IS 19612):** Sets general requirements and test methods for aluminium and aluminium/plastic caps.
**Digital Media and Gaming Standards**
* **IS 19690 : 2026:** Introduces new specifications for age-rating and content descriptor labels for video and digital games.
**Implementation and Transition Schedule**
* **Establishment Date:** All standards listed in the notification were established on 10 March 2026.
* **Concurrent Validity:** For items 1, 2, and 3, the previous versions of the standards will remain in force alongside the new versions until 10 September 2026.
* **Withdrawal Date:** The older standards (IS 8181:1976, IS 8772:1985, and IS 9378:1987) will be officially withdrawn on 10 September 2026.
**Impact Analysis**
**Manufacturers of Ophthalmic and Medical Devices**
**Impact**
Manufacturers of eye surgery instruments and injection systems are affected by updated technical specifications and testing methods.
**Action Required**
Must update manufacturing processes to comply with 2026 revisions and ensure full transition before the 10 September 2026 withdrawal deadline for older standards.
**Video and Digital Game Developers and Distributors**
**Impact**
Stakeholders in the gaming industry are now subject to standardized requirements for age-rating and content labeling.
**Action Required**
Must implement the age-rating and content descriptor label specifications defined in IS 19690 : 2026 on their products and materials.
**Pharmaceutical Packaging and Component Suppliers**
**Impact**
Suppliers of elastomeric parts, prefilled syringe barrels, and vial caps must adhere to new functional and testing requirements.
**Action Required**
Review the new standards (IS 19611, IS 19612, IS 19329) and align product quality and testing protocols with the established 2026 guidelines.
Key Entities Referenced
Bureau of Indian Standards (BIS): The national standards body of India responsible for the establishment, notification, and withdrawal of Indian Standards for various products and services.
Bureau of Indian Standards Rules, 2018: The regulatory framework, specifically Rule 15, under which the Bureau exercises its authority to notify and establish Indian Standards.
Department of Consumer Affairs: The central government department under which the Bureau of Indian Standards operates and issues its notifications.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-17032026-271027
xxxGIDHxxx
CG-DL-E-17032026-271027
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असाधारण
EXTRAORDINARY
भाग III—खण् ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 187] नई दिल्ली, मगं लिार, माच च17, 2026/फाल्ग नु 26, 1947 र् 22, 1947
No. 187] NEW DELHI, TUESDAY, MARCH 17, 2026/PHALGUNA 26, 1947 s 1947
भारतीय मानक ब्य रू ो
(उपभोक्त ा मामल ेजिभाग)
अजधसचू ना
नई दिल्ली, 11 माचच, 2026
संिभ:च HQ-PUB013/1/2020-PUB-BIS (1481).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम
(1) के अनुसरण में भारतीय मानक ब्यूरो एति्द्वारा अजधसूजचत करता ह ैकी जिन भारतीय मानकों के जििरण इसमें संलग्न अनूसूची के
जद्वतीय स्ट्तंभ में दिये गये ह,ैं 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 रहेंगे िब तक िे पााँचिें स्ट्तंभ में इंजगत जतजि को िापस जलए िाने ह|ैं
अनसु चू ी
क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, िर् चतिा प्रजतस्ट्िापन भारतीय मानकों, यदि िापस िापस होन ेकी जतजि
स.ं जतजि
िीर्कच जलए िान ेह,ैं की सख्ं या, िर् च
तिा िीर्कच
(1) (2) (3) (4) (5)
1
आई एस 8181 : 2026 10 माचच 2026 आई एस 8181 – 1976 10 जसतंबर 2026
ररपॉजिटर, आईररस — जिजिजि ररपॉजिटर, आईररस के जलए
(पहला पुनरीक्षण) जिजिजि
1921 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
2 आई एस 8772 : 2026 10 माचच 2026 आई एस 8772 – 1985 10 जसतंबर 2026
सुई धारक, आाँख, बैराक्वेर के पैटनच — जिजिजि सुई धारक, आाँख, बैराक्वेर पैटनच के
(िसू रा पुनरीक्षण) जलए जिजिजि (संिोजधत)
(पहला पुनरीक्षण)
3 आई एस 9378 : 2026 10 माचच 2026 आई एस 9378 – 1987 10 जसतंबर 2026
स्ट्पेकुलम, आाँख, कास्ट्रोजििो के पैटनच — स्ट्पेकुलम, आाँख, कास्ट्रोजििो के
जिजिजि
पैटनच के जलए जिजिजि (संिोजधत)
(िसू रा पुनरीक्षण)
(पहला पुनरीक्षण)
4 आई एस 19282 (भाग 3) : 2026 10 माचच 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 11608-3 : 2022
जचदकत्सा उपयोग के जलए सुई-आधाररत
इंिेक्िन प्रणाली — अपेक्षाएाँ और परीक्षण
पद्धजतयााँ
भाग 3 कंटेनर और एकीकृत द्रि पि
5 आई एस 19282 (भाग 7) : 2026 10 माचच 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 11608-7 : 2016
जचदकत्सा उपयोग के जलए सुई-आधाररत
इंिेक्िन प्रणाली — अपेक्षाएाँ और परीक्षण
पद्धजतयााँ
भाग 7 िजृ िबाजधत व्यजियों के जलए सुगम्यता
6 आई एस 19329 (भाग 6) : 2026 10 माचच 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 11040-6 : 2019
प्रीदफल जसररंि
भाग 6 भरने के जलए तैयार इंिेक्टेबल्स और
जिसंक्रजमत सबअसेंबल्ड जसररंि के जलए
प्लाजस्ट्टक बैरल[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
7 आई एस 19611 (भाग 5) : 2026 10 माचच 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 8871-5 : 2025
पैरेंटरल और फामाचस्ट्युरटकल उपयोग हते ु
उपकरणों के जलए इलास्ट्टोमेररक पार्टसच
भाग 5 कायाचत्मक अपेक्षाएाँ और परीक्षण
8 आई एस 19612 : 2026 10 माचच 2026 लाग ूनहीं लाग ूनहीं
आई एस ओ 8872 : 2022
इन्फ्यूिन बोतलों और इंिेक्िन िीजियों के
जलए एल्यूमीजनयम कैप और
एल्यूमीजनयम/प्लाजस्ट्टक कैप — सामान्फय
अपेक्षाएाँ और परीक्षण पद्धजतयााँ
9 आई एस 19690 : 2026 10 माचच 2026 लाग ूनहीं लाग ूनहीं
िीजडयो और जडजिटल गेम — आयु-रेरटंग
एि ंसामग्री-िणचन लेबल — जिजिजि
जचत्रा गुप्ता, िैज्ञाजनक िी एिं उप महाजनिेिक (हॉलमार्किंग एिं रेननंग)
[जिज्ञापन-III/4/असा./763/2025-26]
BUREAU OF INDIAN STANDARDS
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 11th March, 2026
Ref: HQ-PUB013/1/2020-PUB-BIS (1481).—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)
10 September
1 IS 8181 : 2026 10 March 2026 IS 8181 – 1976 2026
Repositor, Iris — Specification Specification for Repositor, Iris
(First Revision)
10 September
2026
IS 8772 : 2026 10 March 2026 IS 8772 – 1985
2 Needle Holder, Eye, Barraquer’s Specification for Needle Holder,
Eye, Barraquer’s Pattern4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
Pattern — Specification (Modified)
(Second Revision) (First Revision)
10 September
2026
IS 9378 : 2026 10 March 2026 IS 9378 – 1987
3 Speculum, Eye, Castroviejo’s Specification for Speculum, Eye,
Castroviejo’s Pattern (Modified)
Pattern — Specification
(First Revision)
(Second Revision)
NA
IS 19282 (Part 3) : 2026 10 March 2026 NA
4 ISO 11608-3 : 2022
Needle-Based Injection Systems
for Medical Use — Requirements
and Test Methods
Part 3 Containers and Integrated
Fluid Paths
5 IS 19282 (Part 7) : 2026 10 March 2026 NA NA
ISO 11608-7 : 2016
Needle-Based Injection Systems
for Medical Use — Requirements
and Test Methods
Part 7 Accessibility for Persons
with Visual Impairment
NA
6 IS 19329 (Part 6) : 2026 10 March 2026 NA
ISO 11040-6 : 2019
Prefilled Syringes
Part 6 Plastic Barrels for
Injectables and Sterilized
Subassembled Syringes Ready for
Filling
NA
7. IS 19611 (Part 5) : 2026 10 March 2026 NA
ISO 8871-5 : 2025
Elastomeric Parts for Parenterals
and for Devices for Pharmaceutical
Use
Part 5 Functional Requirements
and Testing
NA
8 IS 19612 : 2026 10 March 2026 NA
ISO 8872 : 2022
Aluminium Caps and
Aluminium/Plastic Caps for
Infusion Bottles and Injection Vials[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5
— General Requirements and Test
Methods
NA
9 IS 19690 : 2026 10 March 2026 NA
Video and Digital Games —
Age-Rating and Content
Descriptor Labels —
Specification
CHITRA GUPTA, Scientist G & DDG (Hallmarking and Training)
[ADVT.-III/4/Exty./763/2025-26]
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.