Date: 2026-08-12Category: Extra OrdinaryState: Union GovernmentCountry: India
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
**Executive Summary**
This notification from the Bureau of Indian Standards (BIS) announces the establishment of five new or revised Indian Standards regarding medical electrical equipment and endoscopes, effective from 03 August 2026. The document specifies that older versions of certain standards will remain in force concurrently until their scheduled withdrawal on 03 February 2027. This transition period allows stakeholders to align with the updated technical requirements and safety performance standards.
**Key Points / Main Content**
**Establishment of New Medical Electrical Equipment Standards**
* **IS 13450 (Part 2/Sec 6) : 2026:** Establishes particular requirements for the basic safety and essential performance of microwave therapy equipment, replacing the 2018 version.
* **IS 13450 (Part 2/Sec 75) : 2026:** Introduces new requirements for the safety and performance of photodynamic therapy and photodynamic diagnosis equipment.
* **IS 13450 (Part 2/Sec 83) : 2026:** Establishes standards for the basic safety and essential performance of home light therapy equipment.
**Updates to Endoscope and Endotherapy Device Standards**
* **IS 15732 (Part 1) : 2026:** Provides updated general requirements for medical endoscopes and endotherapy devices, superseding the 2018 version.
* **IS 15732 (Part 4) : 2026:** Details the determination of the maximum width of the insertion portion for endoscopes, replacing the 2021 version.
**Transition and Withdrawal Timelines**
* **Establishment Date:** All standards listed in the notification were officially established on 03 August 2026.
* **Concurrent Validity:** For standards being replaced (Items 1, 4, and 5), the previous versions remain valid alongside the new versions during the transition.
* **Withdrawal Date:** Replaced standards are scheduled to be officially withdrawn on 03 February 2027.
**Impact Analysis**
**Manufacturers of Medical Electrical Equipment and Endoscopes**
**Impact**
Manufacturers of microwave therapy equipment, home light therapy devices, and endoscopes must transition their products to meet the updated 2026 specifications. They benefit from a six-month concurrent period where both old and new standards are valid.
**Action Required**
Manufacturers must review the updated technical requirements (e.g., safety and performance modifications) and ensure their products comply with the 2026 standards before the 03 February 2027 withdrawal of previous versions.
**Testing Laboratories and Certification Bodies**
**Impact**
Laboratories must update their testing protocols and accreditation scopes to include the latest 2026 revisions of the IS 13450 and IS 15732 series.
**Action Required**
Update testing equipment and procedures to reflect the revised parameters, such as the new methods for determining the width of insertion portions in endoscopes.
**Bureau of Indian Standards (BIS) / Regulatory Authorities**
**Impact**
The BIS is responsible for overseeing the transition and ensuring that all new certifications issued after the withdrawal date adhere strictly to the 2026 standards.
**Action Required**
Monitor the adoption of the new standards and manage the formal withdrawal of the 2018 and 2021 versions on the specified date.
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 legal framework under which the BIS establishes or withdraws technical standards, specifically cited regarding Rule 15 for notifying established standards.
IS 13450: A series of Indian Standards for Medical Electrical Equipment, establishing requirements for microwave therapy, photodynamic diagnosis, and home light therapy equipment.
IS 15732: An Indian Standard specifying general requirements and determination of maximum width for medical endoscopes and endotherapy devices.
Department of Consumer Affairs: The administrative department under the Ministry of Consumer Affairs, Food and Public Distribution that oversees the regulatory functions of the BIS.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-12082026-275410
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CG-DL-E-12082026-275410
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असाधारण
EXTRAORDINARY
भाग III—खण् ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 498] नई दिल्ली, बुधिार, अगस्ट्त 12, 2026/श्रािण 21, 1948
No. 498] NEW DELHI, WEDNESDAY, AUGUST 12, 2026/SHRAVAN 21, 1948
भारतीय मानक ब्य रू ो
(उपभोक्त ा मामल े जिभाग)
अजधसचू ना
नई दिल्ली, 5 अगस्ट् त, 2026
सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (1584).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के
उपजनयम (1) के अनुसरण म ें भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के जििरण
इसमें संलग्न अनूसूची के जद्वतीय स्ट्तंभ में दिये गये ह,ैं तीसरे स्ट्तभं में इंजगत जतजि को स्ट्िाजपत हो गये ह|ैं चौिे स्ट्तंभ में दिय े
गय े मानकों के जििरण, यदि कोई हो तो ि े भी साि-साि लाग ू रहगें े िब तक ि े पााँचि ें स्ट्तंभ में इंजगत जतजि को िापस जलए
िाने ह|ैं
6227 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
अनसु चू ी
क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, िर् भ प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस िापस होन ेकी
स.ं जतजि
तिा िीर्कभ जलए िान ेह,ैं की सख्ं या, िर् भ
तिा िीर्कभ
(1) (2) (3) (4) (5)
1 आई एस 13450 (भाग 2/अनुभाग 6) : 03 अगस्ट्त 2026 आई एस 13450 (भाग 03 फ़रिरी 2027
2026 2/अनुभाग 6) : 2018
जचदकत्सीय जिद्युत उपकरण आई ई सी 60601-2-6 : 2012
भाग 2 बुजनयािी सुरक्षा और आिश्यक
जचदकत्सीय जिद्युत उपस्ट्कर
कायभ
भाग 2 बुजनयािी सुरक्षा और
जनष्पािन के जलए जििेर् अपेक्षाएाँ
आिश्यक कायभ जनष्पािन के जलए
अनुभाग 6 माइक्रोिेि िेरेपी उपकरण
जििेर् आिश्यकताएाँ
(IEC 60601-2-6: 2012+AMD1 : अनुभाग 6 माइक्रोिेि जचदकत्सा
2016+AMD2 : 2022 CSV, उपकरण
संिोजधत)
(पहला पुनरीक्षण)
2 आई एस 13450 (भाग 2/अनुभाग 75) : 03 अगस्ट्त 2026 लाग ूनहीं लाग ूनहीं
2026
जचदकत्सीय जिद्युत उपकरण
भाग 2 बुजनयािी सुरक्षा और आिश्यक
कायभ
जनष्पािन के जलए जििेर् अपेक्षाएाँ
अनुभाग 75 फोटोडायनाजमक िेरेपी और
फोटोडायनाजमक जनिान उपकरण
(IEC 60601-2-75 : 2017+AMD1 :
2023 CSV, संिोजधत)
3 आई एस 13450 (भाग 2/अनुभाग 83) : 03 अगस्ट्त 2026 लाग ूनहीं लाग ूनहीं
2026
जचदकत्सीय जिद्युत उपकरण
भाग 2 बुजनयािी सुरक्षा और आिश्यक
कायभ
जनष्पािन के जलए जििेर् अपेक्षाएाँ
अनुभाग 83 आिासीय घरेलू प्रकाि
जचदकत्सा उपकरण
(IEC 60601-2-83 : 2019+AMD1 :
2022 CSV, संिोजधत)
4 आई एस 15732 (भाग 1) : 2026 03 अगस्ट्त 2026 03 फ़रिरी 2027
आई एस ओ 8600-1 : 2025[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
एंडोस्ट्कोप — जचदकत्सा अन्तरीक्षण यंत्र आई एस 15732 (भाग 1) :
और अंत: जचदकत्सा युजियााँ
2018
भाग 1 सामान्य अपेक्षाएाँ
आई एस ओ 8600-1 : 2015
(िसू रा पुनरीक्षण)
एंडोस्ट्कोप — जचदकत्सा
अन्तरीक्षण यन्त्र और अंत:
जचदकत्सा युजियााँ
भाग 1 सामान्य अपेक्षायें
(पहला पुनरीक्षण)
5 आई एस 15732 (भाग 4) : 2026 03 अगस्ट्त 2026 आई एस 15732 (भाग 4) : 03 फ़रिरी 2027
आई एस ओ 8600-4 : 2023 2021
एंडोस्ट्कोप — जचदकत्सा अन्तरीक्षण यंत्र
आई एस ओ 8600-4 : 2014
और अंत: जचदकत्सा युजियााँ
एन्डोस्ट्कोप — जचदकत्सा
भाग 4 सजििेि भाग की अजधकतम
अन्तरीक्षण यन्त्र और अंत:
चौडाई ज्ञात करना (िसू रा पुनरीक्षण)
जचदकत्सा युजियााँ
भाग 4 सजििेि भाग की
अजधकतम चौडाई ज्ञात करना
(पहला पुनरीक्षण)
एस. के. िमा,भ िैज्ञाजनक एफ एि ं उप महाजनिेिक (हॉलमार्किंग)
[जिज्ञापन-III/4/असा./267/2026-27]4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
BUREAU OF INDIAN STANDARDS
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 5th August, 2026
Ref: HQ-PUB013/1/2020-PUB-BIS (1584).—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 Indian Date of
No. Standards Established Establishment Standards to be Withdrawn, if Withdrawal
any
(1) (2) (3) (4) (5)
1 IS 13450 (Part 2/Sec 6) : 2026 03 August 2026 IS 13450 (Part 2/Sec 6) : 2018 03 February 2027
Medical Electrical Equipment IEC 60601-2-6 : 2012
Part 2 Particular Requirements for Medical Electrical Equipment
Basic Safety and Essential Part 2 Particular Requirements for
Performance the Basic Safety and Essential
Section 6 Microwave Therapy Performance
Equipment Section 6 Microwave Therapy
(IEC 60601-2-6 : 2012+AMD1 : Equipment
2016+AMD2 : 2022 CSV, MOD)
(First Revision)
2 IS 13450 (Part 2/Sec 75) : 2026 03 August 2026 NA NA
Medical Electrical Equipment
Part 2 Particular Requirements for
Basic Safety and Essential
Performance
Section 75 Photodynamic Therapy
and Photodynamic Diagnosis
Equipment
(IEC 60601-2-75 : 2017+AMD1 :
2023 CSV, MOD)
3 IS 13450 (Part 2/Sec 83) : 2026 03 August 2026 NA NA
Medical Electrical Equipment
Part 2 Particular Requirements for
Basic Safety and Essential
Performance
Section 83 Home Light Therapy
Equipment
(IEC 60601-2-83 : 2019+AMD1 :
2022 CSV, MOD)
4 IS 15732 (Part 1) : 2026 03 August 2026 IS 15732 (Part 1) : 2018 03 February 2027
ISO 8600-1 : 2025 ISO 8600-1 : 2015
Endoscopes — Medical Endoscopes — Medical
Endoscopes and Endotherapy Endoscopes and Endotherapy
Devices Devices
Part 1 General Requirements Part 1 General Requirements
(Second Revision) (First Revision)[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5
5 IS 15732 (Part 4) : 2026 03 August 2026 IS 15732 (Part 4) : 2021 03 February 2027
ISO 8600-4 : 2023 ISO 8600-4 : 2014
Endoscopes — Medical Endoscopes — Medical
Endoscopes and Endotherapy Endoscopes and Endotherapy
Devices Devices
Part 4 Determination of Maximum Part 4 Determination of
Width of Insertion Portion Maximum
(Second Revision) Width of Insertion Portion
(First Revision)
S. K. VERMA, Scientist F & DDG (Hallmarking)
[ADVT.-III/4/Exty./267/2026-27]
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.