## Policy Analysis Report: Withdrawal of Indian Standards for Medical and Related Equipment
**1. Executive Summary:**
This report analyzes a notification from the Bureau of Indian Standards (BIS) regarding the withdrawal of several Indian Standards (IS) related to medical and related equipment. The notification, dated May 19, 2025, withdraws 33 specific Indian Standards as of May 14, 2025. The report identifies the affected standards, the rationale for the withdrawal (as inferred from the context), and the potential impact on stakeholders. The report is based solely on the provided policy text.
**2. Introduction:**
This report aims to provide information about a notification issued by the Bureau of Indian Standards (BIS) concerning the withdrawal of several Indian Standards for medical and related equipment. The analysis is strictly based on the content of the provided policy text.
**3. Policy Overview:**
* **Amendment:** This notification constitutes an amendment to existing Bureau of Indian Standards regulations.
* **Core Objective(s):** The primary objective, as inferred from the text, is to update and/or streamline the Indian Standards related to medical and related equipment by withdrawing outdated or superseded standards.
**4. Background and Rationale:**
* **Amendment:** The rationale for this specific amendment, the withdrawal of standards, is likely due to several factors: The standards may be outdated, revised versions of the same standards may exist, or the products covered by these standards may no longer be relevant or in production. This aims to maintain the relevance and accuracy of the BIS standards catalogue. The withdrawn standards cover a range of items from baby incubators to tracheostomy tubes, suggesting a broad effort to revise standards in this sector.
**5. Key Provisions / Changes:**
* **Amendment:** This is a focused amendment that *specifically* concerns the withdrawal of the 33 identified Indian Standards.
* **Part of Original Policy Changed:** The amendment affects the existing register of Indian Standards, specifically those related to medical and related equipment.
* **New Rule/Provision:** The new provision is that the Indian Standards listed in the schedule are *no longer valid* as of May 14, 2025. This means products and processes formerly governed by these standards will no longer be assessed against them by BIS.
* **Difference/Effect of Change:** The effect of this change is that manufacturers and suppliers are no longer required to comply with the withdrawn standards. It is probable that revised or updated standards will (or already do) exist. They should be consulted instead.
**6. Target Audience and Stakeholders:**
Based on the provided text, the primary stakeholders affected by this policy amendment include:
* Manufacturers of medical equipment and related products (e.g., syringes, hospital beds, incubators, catheters, first aid kits).
* Suppliers and distributors of medical equipment and related products.
* Hospitals and healthcare facilities that procure and use the equipment covered by the withdrawn standards.
* Testing and certification bodies involved in assessing compliance with Indian Standards.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency:** The Bureau of Indian Standards (BIS), under the Department of Consumer Affairs, is the responsible agency for implementing this withdrawal.
* **Timelines:** The key timeline is that the listed standards were withdrawn as of May 14, 2025.
* **Amendment-Specific Implementation:** Manufacturers should immediately cease using the withdrawn standards as a benchmark for production and quality control. Certification bodies must stop assessing products against these standards.
**8. Expected Outcomes / Impact of Changes:**
* **Amendment:** The likely intended outcomes of these withdrawals include:
* Reduced confusion in the market by eliminating outdated standards.
* Encouraging manufacturers to adopt the latest and most relevant standards for their products (if revised versions exist).
* Facilitating innovation and technological advancement in the medical equipment sector by removing potentially obsolete requirements.
**9. Conclusion:**
The notification from the Bureau of Indian Standards represents a significant update to the regulatory landscape for medical and related equipment. The withdrawal of these 33 Indian Standards, effective May 14, 2025, requires immediate attention from manufacturers, suppliers, healthcare providers, and certification bodies. This action likely indicates a broader effort to modernize and streamline Indian Standards to reflect current technological advancements and best practices in the medical equipment sector. It is recommended that stakeholders monitor the BIS website for updated standards and guidelines.
Key Entities Referenced
NEW DELHI: Location where the notification was issued.
FRIDAY, MAY 23, 2025: Date of publication of the Gazette of India.
JYAISTHA 2, 1947: Date of publication according to the Indian national calendar.
HQPUB01712020PUBBIS 1240: Reference number related to the notification.
Bureau of Indian Standards: Organization responsible for issuing the standards and the notification.
Bureau of Indian Standards Rules, 2018: The set of rules under which the notification is issued.
Indian Standards: Standards being withdrawn as per the notification.
SCHEDULE: Refers to the annexed schedule listing the withdrawn Indian Standards.
May 2025: Date of withdrawal for the listed Indian Standards.
IS 3120 : 1999: Indian Standard for Baby Incubators Specification Second revision.
IS 3236 : 1992: Indian Standard for Hypodermic Syringes for General Purposes Specification Second Revision
IS 3237 Part 1 1985: Indian Standard for Special Purpose Syringes Part 1 Insulin Syringes Second Revision
IS 3237 Part 2 1985: Indian Standard for Special Purpose Syringes Part 2 Tuberculin Syringes Second Revision
IS 3237 Part 3 1985: Indian Standard for Special Purpose Syringes Part 3 BCG Syringes Second Revision
IS 3237 Part 4 1986: Indian Standard for Special Purpose Syringes Part 4 Vaccine Syringe
IS 3237 Part 5 1986: Indian Standard for Special Purpose Syringes Part 5 Post Operation Care Syringe Second Revision
IS 3237 Part 6 1986: Indian Standard for Special Purpose Syringes Part 6 Irrigation Syringe
IS 3237 Part 7 1986: Indian Standard for Special Purpose Syringe Part 7 Forced Feeding Syringe
IS 3237 Part 8 1986: Indian Standard for Special Purpose Syringes Part 8 Angiography Syringe
IS 3423 1973: Indian Standard for Glass Containers for Transfusion Fluids First Revision
IS 3994 : 1993: Indian Standard for Bowls, Wash Specification Second Revision
IS 3997 1982: Indian Standard for Jars, Ointment First Revision
IS 4034 1979: Indian Standard for Castors for Hospital Equipment First Revision
IS 4363 1980: Indian Standard for Drip Counter E. M. S. Pattern First Revision
IS 5029 1979: Indian Standard for Bedsteads, Hospital, General Purposes First Revision
IS 5336 1969: Indian Standard for Back Rest
IS 5337 1969: Indian Standard for Cot, Dropside, Baby, Hospital
IS 5630 : 1994: Indian Standard for Cribs Cradles, Maternity Specification First Revision
IS 6877 1977: Indian Standard for Cabinet, Instruments First Revision
IS 7036 1982: Indian Standard for Table, Postmortem First Revision
IS 7081 1973: Indian Standard for Stool, Revolving, for Hospital Use
IS 7171 1974: Indian Standard for Drip Counter with Filter
IS 7523 1974: Indian Standard for Rubber Catheter Urinary
IS 7627 1975: Indian Standard for Gag, Mouth, Masons Pattern
IS 10263 1982: Indian Standard for Deep Fat Fryer, Single and Double Pan Electrically Operated, for Large Catering Establishments
IS 10264 1982: Indian Standard for Trolley, Hot Food, for Hospital and Industrial Canteens
IS 10308 1982: Indian Standard for Tracheostomy Tubes and Guides, Cubleys Pattern
IS 10783 1983: Indian Standard for PatientLifting Devices, Mobile, Manually Operated
IS 13115 : 1991: Indian Standard for Portable FirstAid Kit for General Use Specification
IS 13179 : 1991: Indian Standard for ENT Surgery Instruments Tracheostomy Tubes, Chevaliar Jacksons Pattern Specification
IS 14193 : 1994: Indian Standard for Ovulation Thermometers Specification
CHITRA GUPTA: Name of the Scientist G issuing the notification.
DDG Hallmarking and Training: Designation of the issuing authority.
Department of Consumer Affairs: The government department to which the Bureau of Indian Standards belongs
the 19th May, 2025: Date of Notification
Government of India Press, Ring Road, Mayapuri, New Delhi110064: Location of the printing press
Controller of Publications, Delhi110054: Publisher of the document
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-24052025-263366
xxxGIDHxxx
CG-DL-E-24052025-263366
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असाधारण
EXTRAORDINARY
भाग III—खण्ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 387] नई दिल्ली, िक्रु िार, मई 23, 2025/ज्य ेष्ठ 2, 1947
No. 387] NEW DELHI, FRIDAY, MAY 23, 2025/JYAISTHA 2, 1947
भारतीय मानक ब्य रू ो
(उपभोक्त ा मामल ेजिभाग)
अजधसचू ना
नई दिल्ली, 19 मई, 2025
सिं भ:भ HQ-PUB017/1/2020-PUB-BIS (1240).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के
उपजनयम (1) के अनुसरण म ें भारतीय मानक ब्यूरो एतिद्वाराअजधसूजचत करता ह ै की जिन भारतीय मानको का जििरण
इसके साथ सलं ग्र अनूसूची म े दिया गया ह,ै उन्ह ें कॉलम तीन में इंजगत तारीख को रद्द कर दिया या और िाजपस ल े जलया
गया ह।ै
अनसु चू ी
क्रम िाजपस जलए गए भारतीय मानकों की सख्ं या, िर् भतथा िीर्कभ िाजपस जलए िान े
स.ं की तारीख
(1) (2) (3)
14 मई 2025
1 आई एस 3120 : 1999
जििु सेने का यंत्र — जिजिजि
(िसू रा पनु रीक्षण)
3389 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
14 मई 2025
2 आई एस 3236 : 1992
सामान्य प्रयोिनों के जलए अधःत्िचीय जसरेंि की जिजिजि
(िसू रा पनु रीक्षण)
14 मई 2025
3 आई एस 3237 (भाग 1) – 1985
जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 1 इंसुजलन जसररंि
(िसू रा पुनरीक्षण)
14 मई 2025
4 आई एस 3237 (भाग 2) – 1985
जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 2 ट्यूबरक्युजलन जसररंि
(िसू रा पनु रीक्षण)
14 मई 2025
5 आई एस 3237 (भाग 3) – 1985
जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 3 बीसीिी जसररंि
(िसू रा पनु रीक्षण)
14 मई 2025
6 आई एस 3237 (भाग 4) – 1986
जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 4 िैक्सीन जसररंि
14 मई 2025
7 आई एस 3237 (भाग 5) – 1986
जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 5 ऑपरेिन के बाि िेखभाल के जलए जसररंि
(िसू रा पुनरीक्षण)
14 मई 2025
8 आई एस 3237 (भाग 6) – 1986
जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 6 इररगिे न जसररंि
आई एस 3237 (भाग 7) – 1986 14 मई 2025
9 जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 7 बलपूिभक आहार िेन े िाली जसररंि
आई एस 3237 (भाग 8) – 1986 14 मई 2025
10 जििेर् प्रयोिन जसररंि के जलए जिजिजि
भाग 8 एंजियोग्राफी जसररंि[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
14 मई 2025
11 आई एस 3423 – 1973
रांसफ्यूिन फ्लूइड्स के जलए कााँच के कंटेनर के जलए जिजिजि
(पहला पुनरीक्षण)
14 मई 2025
12 आई एस 3994 : 1993
घाि की धलु ाई के जलए कटोररयााँ — जिजिजि
(िसू रा पनु रीक्षण)
14 मई 2025
13 आई एस 3997 – 1982
िार, मलहम के जलए जिजिजि
(पहला पुनरीक्षण)
14 मई 2025
14 आई एस 4034 – 1979
अस्ट्पताल उपकरण के जलए कैस्ट्टर के जलए जिजिजि
(पहला पुनरीक्षण)
14 मई 2025
15 आई एस 4363 – 1980
ई.एम.एस. पैटन भजिप काउंटर के जलए जिजिजि
(पहला पुनरीक्षण)
14 मई 2025
16 आई एस 5029 – 1979
अस्ट्पताल के सामान्य प्रयोिन के जलए पलगं ों के जलए जिजिजि
(पहला पुनरीक्षण)
14 मई 2025
17 आई एस 5336 – 1969
बैक रेस्ट्ट के जलए जिजिजि
14 मई 2025
18
आई एस 5337 – 1969
अस्ट्पताल के जलए एक तरफ खलु न े िाले जििु के पालन े के जलए जिजिजि
14 मई 2025
आई एस 5630 – 1994
19
प्रसूजत सम्बंजधत दक्रब ( पालना ) — जिजिजि
(पहला पुनरीक्षण)
आई एस 6877 – 1977 14 मई 2025
20 कैजबनेट, उपकरण के जलए जिजिजि
(पहला पनु रीक्षण)4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
14 मई 2025
21
आई एस 7036 – 1982
पोस्ट्टमाटभम टेबल के जलए जिजिजि
(पहला पुनरीक्षण)
14 मई 2025
22
आई एस 7081 – 1973
अस्ट्पताल उपयोग के जलए घूमने, िाला स्ट्टूल, के जलए जिजिजि
14 मई 2025
23
आई एस 7171 – 1974
दफल्टर सजहत जिप काउंटर के जलए जिजिजि
14 मई 2025
24
आई एस 7523 – 1974
रबड़ कैथेटर (मूत्रमागीय) के जलए जिजिजि
14 मई 2025
25
आई एस 7627 – 1975
गैग, माउथ, मेसन पैटन भके जलए जिजिजि
14 मई 2025
26
आई एस 10263 – 1982
बड़े कैटररंग प्रजतष्ठानों के जलए ससंगल और डबल पैन इलेजक्रक डीप फैट फ्रायर के जलए
जिजिजि
14 मई 2025
27
आई एस 10264 – 1982
अस्ट्पताल और औद्योजगक कैंटीन के जलए गमभ भोिन रॉली के जलए जिजिजि
14 मई 2025
28
आई एस 10308 – 1982
रेदकयोस्ट्टोमी ट्यूब और गाइड के जलए जिजिजि, क्यूबली पैटन भ
14 मई 2025
29
आई एस 10783 – 1983
मोबाइल, मेन्यअु ली संचाजलत रोगी उठान े िाले उपकरणों के जलए जििजि[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5
14 मई 2025
30
आई एस 13115 : 1991
सामान्य उपयोग के जलए सुिाह्य प्राथजमक उपचार दकट — जिजिजि
14 मई 2025
31
आई एस 13115 : 1991
सामान्य उपयोग के जलए सुिाह्य प्राथजमक उपचार दकट — जिजिजि (जद्वभार्ी)
14 मई 2025
32
आई एस 13179 : 1991
कान, नाक तथा गला िल्य जचदकत्सा उपकरण — श्वास नजलकाएं, जििैजलयर िैकसन
नमूने की — जिजिजि
14 मई 2025
33
आई एस 14193 : 1994
जडम्बक्षरण थमाभमीटर — जिजिजि
जचत्रा गुप् ता, िैज्ञाजनक िी एि ंउप महाजनिेिक (हॉलमार्किंग एि ं रेसनंग)
[जिज्ञापन-III/4/असा./120/2025-26]
BUREAU OF INDIAN STANDARDS
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 19th May, 2025
Ref: HQ-PUB017/1/2020-PUB-BIS (1240).—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 the Indian standards, particulars of
which are given in schedule hereto annexed have been cancelled and stands withdrawn from the date indicated against
it in the third column.
SCHEDULE
Sl. No., Year & Title of the Indian Standard Withdrawn Date of Withdrawal
No.
(1) (2) (3)
14 May 2025
1 IS 3120 : 1999
Baby Incubators — Specification
(Second revision)
14 May 2025
2 IS 3236 : 1992
Hypodermic Syringes for General Purposes — Specification
(Second Revision)6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
Sl. No., Year & Title of the Indian Standard Withdrawn Date of Withdrawal
No.
(1) (2) (3)
14 May 2025
3 IS 3237 (Part 1) – 1985
Specification for Special Purpose Syringes
Part 1 Insulin Syringes
(Second Revision)
14 May 2025
4 IS 3237 (Part 2) – 1985
Specification for Special Purpose Syringes
Part 2 Tuberculin Syringes
(Second Revision)
14 May 2025
5 IS 3237 (Part 3) – 1985
Specification for Special Purpose Syringes
Part 3 BCG Syringes
(Second Revision)
14 May 2025
6 IS 3237 (Part 4) – 1986
Specification for Special Purpose Syringes
Part 4 Vaccine Syringe
14 May 2025
7 IS 3237 (Part 5) – 1986
Specification for Special Purpose Syringes
Part 5 Post Operation Care Syringe
(Second Revision)
14 May 2025
8 IS 3237 (Part 6) – 1986
Specification for Special Purpose Syringes
Part 6 Irrigation Syringe
14 May 2025
9 IS 3237 (Part 7) – 1986
Specification for Special Purpose Syringe
Part 7 Forced Feeding Syringe
IS 3237 (Part 8) – 1986 14 May 2025
10
Specification for Special Purpose Syringes
Part 8 Angiography Syringe
14 May 2025
11 IS 3423 – 1973
Specification for Glass Containers for Transfusion Fluids
(First Revision)
IS 3994 : 1993 14 May 2025
12
Bowls, Wash — Specification
(Second Revision)
14 May 2025
13 IS 3997 – 1982
Specification for Jars, Ointment
(First Revision)
IS 4034 – 1979 14 May 2025
14
Specification for Castors for Hospital Equipment
(First Revision)[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 7
Sl. No., Year & Title of the Indian Standard Withdrawn Date of Withdrawal
No.
(1) (2) (3)
14 May 2025
15 IS 4363 – 1980
Specification for Drip Counter E. M. S. Pattern
(First Revision)
14 May 2025
16 IS 5029 – 1979
Specification for Bedsteads, Hospital, General Purposes
(First Revision)
14 May 2025
17 IS 5336 – 1969
Specification for Back Rest
14 May 2025
18 IS 5337 – 1969
Specification for Cot, Dropside, Baby, Hospital
14 May 2025
19 IS 5630 : 1994
Cribs (Cradles), Maternity — Specification
(First Revision)
14 May 2025
20 IS 6877 – 1977
Specification for Cabinet, Instruments
(First Revision)
14 May 2025
21 IS 7036 – 1982
Specification for Table, Postmortem
(First Revision)
14 May 2025
22 IS 7081 – 1973
Specification for Stool, Revolving, for Hospital Use
14 May 2025
23 IS 7171 – 1974
Specification for Drip Counter with Filter
14 May 2025
24 IS 7523 – 1974
Specification for Rubber Catheter ( Urinary )
14 May 2025
25 IS 7627 – 1975
Specification for Gag, Mouth, Mason’s Pattern
14 May 2025
26 IS 10263 – 1982
Specification for Deep Fat Fryer, Single and Double Pan Electrically Operated, for
Large Catering Establishments
14 May 2025
27 IS 10264 – 1982
Specification for Trolley, Hot Food, for Hospital and Industrial Canteens
14 May 2025
28 IS 10308 – 1982
Specification for Tracheostomy Tubes and Guides, Cubley’s Pattern8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
Sl. No., Year & Title of the Indian Standard Withdrawn Date of Withdrawal
No.
(1) (2) (3)
14 May 2025
29 IS 10783 – 1983
Specification for Patient-Lifting Devices, Mobile, Manually Operated
14 May 2025
30 IS 13115 : 1991
Portable First-Aid Kit for General Use — Specification
14 May 2025
31 IS 13115 : 1991
Portable First-Aid Kit for General Use — Specification (Bi-Lingual)
14 May 2025
32 IS 13179 : 1991
ENT Surgery Instruments — Tracheostomy Tubes, Chevaliar Jackson’s Pattern —
Specification
14 May 2025
33 IS 14193 : 1994
Ovulation Thermometers — Specification
CHITRA GUPTA, Scientist G & DDG (Hallmarking and Training)
[ADVT.-III/4/Exty./120/2025-26]
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.