Executive Summary:
This notification from the Bureau of Indian Standards announces the establishment and concurrent enforcement of several Indian Standards related to medical electrical equipment, specifically concerning X-ray equipment. The standards are effective from May 27, 2016, with some having cancellation dates in 2017. The notification provides details of the standards, their establishment dates, and cancellation dates where applicable.
Key Points / Main Content:
* **Establishment of Indian Standards:**
* A series of Indian Standards (IS) concerning medical electrical equipment, specifically X-ray equipment, have been established.
* These standards are based on IEC (International Electrotechnical Commission) standards.
* **Details of Standards:**
* IS 13450 Part 2 Section 43: X-ray Equipment for Interventional Procedures (First Revision)
* IS 13450 Part 2 Section 44: X-ray Equipment for Computed Tomography (First Revision)
* IS 13450 Part 2 Section 45: Mammographic X-ray Equipment and Mammographic Stereotactic Devices (First Revision)
* IS 13450 Part 2 Section 54: X-ray Equipment for Radiography and Radioscopy
* IS 13450 Part 2 Section 63: Dental Extra-Oral X-ray Equipment
* IS 13450 Part 2 Section 65: Dental Intra-Oral X-ray Equipment
* **Effective and Cancellation Dates:**
* All listed standards were established on May 27, 2016.
* IS 13450 Part 2 Sections 43, 44, and 45 will be cancelled on May 27, 2017.
* Corresponding standards to be cancelled concurrently are IEC standards from 2007, 2008, 2009, 2010, and 2011.
* **Availability of Standards:**
* Copies of the standards are available for purchase at the Bureau of Indian Standards offices and online.
Impact Analysis:
* **Manufacturers of Medical Electrical Equipment (X-ray):**
* Impact: Must comply with the newly established Indian Standards for manufacturing and performance of X-ray equipment.
* Action Required: Review and implement the requirements of the new standards (IS 13450 series) in their manufacturing processes and product design.
* **Healthcare Providers and Medical Facilities:**
* Impact: Need to ensure that the X-ray equipment they use meets the specified Indian Standards for safety and performance.
* Action Required: Verify that their existing and future X-ray equipment complies with the new standards and replace or upgrade equipment as necessary.
* **Bureau of Indian Standards (BIS):**
* Impact: Responsible for enforcing and maintaining the standards.
* Action Required: Make the standards accessible to relevant parties and oversee compliance.
Key Entities Referenced
Bureau of Indian Standards: A national standards body of India responsible for the formulation of standards.
Bureau of Indian Standards Rules, 1987: The set of rules governing the operations of the Bureau of Indian Standards.
Indian Standards: A set of standards established by the Bureau of Indian Standards.
Ministry of Consumer Affairs, Food and Public Distribution: A ministry of the Government of India.
Department of Consumer Affairs: A department under the Ministry of Consumer Affairs, Food and Public Distribution.
IS 13450: A series of Indian Standards related to medical electrical equipment.
IEC 60601: A series of international electrotechnical commission standards for medical electrical equipment.
New Delhi: The location of the head office of the Bureau of Indian Standards and place of publication.
jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99
vlk/kj.k
EXTRAORDINARY
Hkkx II—[k.M 3—mi&[k.M (ii)
PART II—Section 3—Sub-section (ii)
izkf/dkj ls izdkf'kr
PUBLISHED BY AUTHORITY
la- 1318] ubZ fnYyh] lkseokj] ebZ 30] 2016@T;s"B 9] 1938
No. 1318] NEW DELHI, MONDAY, MAY 30, 2016/ JYAISTHA 9, 1938
उउउउपपपपभभभभोोोो(cid:5)(cid:5)(cid:5)(cid:5)ाााा ममममााााममममलललल,,ेे,,ेे खखखखाााा(cid:12)(cid:12)(cid:12)(cid:12) औऔऔऔरररर ससससााााववववजज(cid:17)(cid:17)जज(cid:17)(cid:17) ििििननननकककक ििििववववततततररररणणणण मममम(cid:25)(cid:25)ंं(cid:25)(cid:25)ंं ााााललललयययय
((((उउउउपपपपभभभभोोोो(cid:6)(cid:6)(cid:6)(cid:6)ाााा ममममााााममममलललल ेे ेेििििववववभभभभाााागगगग))))
((((भभभभााााररररततततीीीीयययय ममममााााननननकककक (cid:22)(cid:22)(cid:22)(cid:22)ययययूरूरूरूरोोोो))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6)ल ी, 27 मई , 2016
ककककाााा.... आआआआ.... 1111999900008888((((अअअअ))))....———— भारतीय मानक (cid:16)य रू ो िनयम, 1987 के िनयम 7 के उपिनयम (1) के खंड (ख) के
अनुसरण म (cid:19) भारतीय मानक (cid:16) यूरो एत(cid:22)ारा अिधसिू चत करता ह ै(cid:4)क िजन भारतीय मानक(cid:31) के िववरण नीचे अनुसचू ी
म(cid:19) (cid:4)दए गए ह $वे % थािपत हो गये ह।$
अअअअननननससुुससुु ूचूचूचूचीीीी
(cid:1)म सं(cid:6)य ा (cid:9)थ ािपत भारतीय मानक (क(cid:20)) क(cid:22) सं(cid:6) या वष(cid:25) (cid:9) थािपत ितिथ भारतीय मानक(क(cid:20)) जो (cid:30)क र(cid:31) होने र(cid:31) होने क(cid:22)
और शीष(cid:25)क ह," अगर ह,ै क(cid:22) सं(cid:6) या, वष(cid:25) और ितिथ
शीष(cid:25)क
(1) (2) (3) (4) (5)
1. आई एस 13450 (भाग 2/अनुभाग 43) : 27 मई 2016 आई एस 13450 (भाग 2/अनुभाग 27 मई 2017
2016/आई ई सी 60601-2-43 : 2010 43) : 2008
िच(cid:30)क$सीय िव%ुत् उप(cid:9)कर भाग 2 बुिनयादी
सुर)ा और आव+यक काय(cid:25) िन,पादन के िलए
िवशेष आव+यकताएं अनुभाग 43 ह(cid:9)त)ेप
0(cid:30)(cid:1)या1 के िलए ए2स-रे उपकरण (पहला
पुनरी)ण)
2685 GI/2016 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
2. आई एस 13450 (भाग 2/अनुभाग 44) : 27 मई 2016 आई एस 13450 (भाग 2/अनुभाग 27 मई 2017
2016/आई ई सी 60601-2-44 : 2009 44) : 2007
िच(cid:30)क$सीय िव%ुत् उप(cid:9)कर भाग 2 बुिनयादी
सुर)ा और आव+यक काय(cid:25) िन,पादन के िलए
िवशेष आव+यकताएं अनुभाग 44 क56यु7टड
टोमो9ाफ(cid:22) के िलए ए2स-रे उपकरण (पहला
पुनरी)ण)
3. आई एस 13450 (भाग 2/अनुभाग 45) : 27 मई 2016 आई एस 13450 (भाग 2/अनुभाग 27 मई 2017
2016/आई ई सी 60601-2-45 : 2011 45) : 2007
िच(cid:30)क$सीय िव%ुत् उप(cid:9)कर भाग 2 बुिनयादी
सुर)ा और आव+यक काय(cid:25) िन,पादन के िलए
िवशेष आव+यकताएं अनुभाग 45
मेमो9ा(cid:30)फक ए2स-रे उपकरण और
मेमो9ा(cid:30)फक (cid:9)टी7रयोटिै2टक उपकरण
(पहला पुनरी)ण)
4. आई एस 13450 (भाग 2/अनुभाग 54) : 27 मई 2016 NA NA
2016/आई ई सी 60601-2-54 : 2009
िच(cid:30)क$सीय िव%ुत् उप(cid:9)कर भाग 2 बुिनयादी
सुर)ा और आव+यक काय(cid:25) िन,पादन के िलए
िवशेष आव+यकताएं अनुभाग 54
रेिडयो9ाफ(cid:22) एवं रेिडयो(cid:9)कोपी म= 0यु> होने
वाले ए2स-रे उपकरण
5. आई एस 13450 (भाग 2/अनुभाग 63) : 27 मई 2016 NA NA
2016/आई ई सी 60601-2-63 : 2012
िच(cid:30)क$सीय िव%ुत् उप(cid:9)कर भाग 2 बुिनयादी
सुर)ा और आव+यक काय(cid:25) िन,पादन के िलए
िवशेष आव+यकताएं अनुभाग 63 दतं
ए2(cid:9)?ा-ओरल ए2स-रे उपकरण
6. आई एस 13450 (भाग 2/अनुभाग 65) : 27 मई 2016 NA NA
2016/आई ई सी 60601-2-65 : 2012
िच(cid:30)क$सीय िव%ुत् उप(cid:9)कर भाग 2 बुिनयादी
सुर)ा और आव+यक काय(cid:25) िन,पादन के िलए
िवशेष आव+यकताएं अनुभाग 65 दतं इं?ा-
ओरल ए2स-रे उपकरण
इइइइसससस भभभभााााररररततततीीीीयययय ममममााााननननकककक कककक(cid:26)(cid:26)(cid:26)(cid:26) (cid:27)(cid:27)(cid:27)(cid:27)ििििततततयययय(cid:28)(cid:28)(cid:28)(cid:28) भभभभााााररररततततीीीीयययय ममममााााननननकककक (cid:22)(cid:22)(cid:22)(cid:22)ययययररूूररूू ोोोो, ममममााााननननकककक भभभभववववनननन, 9999, बबबबहहहहााााददददररररुुुु शशशशााााहहहह ज़ज़ज़ज़फफफफरररर ममममाााागगगग,$$$$ ननननईईईई &&&&दददद’’’’लल लल ीीीी 111111110000 000000002222 (((())ेे))ेे ीीीीयययय ककककााााययययाााालल$$लल$$ यययय**** ::::
ननननईईईई &&&&दददद’’’’ललललीीीी, ककककोोोोललललककककतततताााा, चचचचडडंंडडंं ीीीीगगगगढ़ढ़ढ़ढ़, चचचच,,ेे,,ेे ईईईई, ममममुंबुंबुंबुंबईईईई, ततततथथथथाााा शशशशााााखखखखाााा ककककााााययययाााा$ल$ल$ल$लयययय****:::: अअअअहहहहममममददददााााबबबबाााादददद, बबबबंगंगंगंगललललौौौौरररर, भभभभोोोोपपपपाााालललल, भभभभुवुवुवुवनननन00ेे00ेे रररर, ककककोोोोययययबबंंबबंं ततततूरूरूरूर, गगगगुवुवुवुवााााहहहहााााटटटटीीीी,
हहहहददैैददैै ररररााााबबबबाााादददद, जजजजययययपपपपुरुरुरुर, पपपपटटटटननननाााा, पपपपणणूूणणूू ेे ेेततततथथथथाााा ककककोोोोििििचचचच मममम 22 22ििििबबबब3333(cid:26)(cid:26)(cid:26)(cid:26) हहहहततेेततेे ुु ुुउउउउपपपपलललल(cid:22)(cid:22)(cid:22)(cid:22)धधधध हहहह।।।।5555 भभभभााााररररततततीीीीयययय ममममााााननननकककक**** ककककोोोो http://www.standardsbis.in 7777ाााारररराााा इइइइंंंटंटटटररररननननटटैैटटैै
पपपपरररर खखखखररररीीीीददददाााा जजजजाााा ससससककककतततताााा हहहह।।ैै।।ैै
[संदभ * : पब- 3 /2/ 2015]
पी.एम पंतूलू,,,, व+ै ािनक –––– एफ एवं उपमहािनदशे क (मानक0करण)¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3
MINISTRY OF CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
(Department of Consumer Affairs)
(BUREAU OF INDIAN STANDARDS)
NOTIFICATION
New Delhi, the 9th March, 2016
S.O. 1908(E).— In pursuance of Clause (b) of sub-rule (1) of Rules 7 of the Bureau of Indian Standards Rules,
1987, the Bureau of Indian Standards hereby notifies that the Indian Standards, particulars of which are given in the
second column of Schedule hereto annexed has 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 cancelled on the date indicated against them in the fifth column.
SCHEDULE
Sl. No. & Year of the Indian Date of No. & Year of the Indian Date of cancellation
No. Standards Established Establishment Standards to be cancelled, if
any
(1) (2) (3) (4) (5)
1. IS 13450 (Part 2/Section 43) : 27 May 2016 IS 13450 (Part 2/Section 43) 27 May 2017
2016/IEC 60601-2-43 : 2010 : 2008
Medical Electrical Equipment
Part 2 Particular Requirements
for the Basic Safety and
Essential Performance Section
43 X-ray Equipment for
Interventional Procedures (First
Revision)
2. IS 13450 (Part 2/Section 44) : 27 May 2016 IS 13450 (Part 2/Section 44) 27 May 2017
2016/IEC 60601-2-44 : 2009 : 2007
Medical Electrical Equipment
Part 2 Particular Requirements
for the Basic Safety and
Essential Performance Section
44 X-ray equipment for
computed Tomography (First
Revision)
3. IS 13450 (Part 2/Section 45) : 27 May 2016 IS 13450 (Part 2/Section 45) 27 May 2017
2016/IEC 60601-2-45 : 2011 : 2007
Medical Electrical Equipment
Part 2 Particular Requirements
for the Basic Safety and
Essential Performance Section
45 Mammographic X-ray
Equipment and Mammographic
Stereotactic Devices (First
Revision)
4. IS 13450 (Part 2/Section 54) : 27 May 2016 NA NA
2016/IEC 60601-2-54 : 2009
Medical Electrical Equipment
Part 2 Particular Requirements
for the Basic Safety and
Essential Performance Section
54 X-ray Equipment for
Radiography and Radioscopy
5555.... IS 13450 (Part 2/Section 63) : 27 May 2016 NA NA
2016/IEC 60601-2-63 : 20124 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
Medical Electrical Equipment
Part 2 Particular Requirements
for the Basic safety and
Essential Performance Section
63 Dental Extra-Oral X-ray
Equipment
6666.... IS 13450 (Part 2/Section 65) : 27 May 2016 NA NA
2016/IEC 60601-2-65 : 2012
Medical Electrical Equipment
Part 2 Particular Requirements
for the Basic Safety and
Essential Performance Section
65 Dental Intra-Oral X-ray
Equipment
Copies of these standards are available for sale with the Bureau of Indian Standards, Manak Bhavan, 9 Bahadur Shah
Zafar Marg, New Delhi – 110002 and Regional Offices : Kolkata, Chandigarh, Chennai, Mumbai and also Branch
Offices: Ahmedabad, Bangalore, Bhopal, Bhubaneshwar, Coimbatore, Guwahati, Hyderabad, Jaipur, Nagpur, Patna,
Pune, Kochi. Online purchase of Indian Standards can be made at http://www.standardsbis.in .
[Ref: PUB/3/2/2015]
P. M. PANTULU, Sc. F & DDG (Standardization)
Uploaded by the Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.