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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 13450 (Part 1/Sec 10) : 2024

IS Title/आईएस शीर्षक : Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 10 Requirements for the development of physiologic closed-loop controllers (First Revision)

Superseding IS/सुपरसीडिंग आईएस : IS 13450 : Part 1 : Sec 10 : 2019

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : 1

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Others

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : No reaffirmation

Technical Department/तकनीकी विभाग : MHD (Medical Equipment and Hospital Planning Department)

Technical Committee/तकनीकी समिति : MHD 15 (Electromedical, Diagnostic Imaging and Radiotherapy Equipment Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. GURPREET KAUR BHOMBRA (SCIENTIST-C)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 6

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License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

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Cross Reference Details

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Composition

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Corrigendum : 0

Cross Reference Details

Indian Standards Referred In IS IS 13450 (Part 1/Sec 10) : 2024
:

1	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
2	IS/ISO 9000 : 2015 ISO 9000 : 2015 Reviewed In : 2020	Quality management systems - Fundamentals and vocabulary (Fourth Revision)	MSD 2
3	IS 16483 : 2017 Reviewed In : 2023	Geosynthetics - Method for microscopic evaluation of the dispersion of carbon black in polyolefin geosynthetics	TXD 30
4	IS/ISO 10993-15 : 2000 ISO 10993-15 : 2000	Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys	MHD 19
5	IS/ISO 10993-10 : 2010 ISO 10993-10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
6	IS 6659 : 1976 Reviewed In : 2021	Electronic Grade Ceramic Materials	ETD 2

International Standards Referred In IS 13450 (Part 1/Sec 10) : 2024

1	IEC 60601 : 1 : 6 2010

IS 13450 (Part 1/Sec 10) : 2024
is Referred in following Indian Standards :

1	IS/IEC 80601 : Part 2 : Sec 35 : 2009	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets, pads or mattresses and intended for heating in medical use	MHD 15
2	IS 17567 : Part 1 : 2021	ISO TS 19807-1:2019 Nanotechnologies Magnetic nanomaterials Part 1: Specification of characteristics and measurements for magnetic nanosuspensions	MTD 33
3	IS 17614 : Part 20 : 2021	Water Quality Sampling Part 20 Guidance on the Use of Sampling Data for Decision Making Compliance with Thresholds and Classification Systems	CHD 36
4	IS 17754 : Part 1 : 2022	Agricultural grain driers - Determination of drying performance-Part1:General	FAD 20
5	IS 17791 : Part 4 : 2022	Protective equipment for martial arts: Part 4: Additional requirements and test methods for head protectors	PGD 41
6	IS 13450 : Part 1 : Sec 10 : 2019	Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers	MHD 15
7	IS 13450 : Part 1 : Sec 10 : 2019	Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers	MHD 15
8	IS 13450 : Part 1 : Sec 10 : 2019	Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers	MHD 15
9	IS 13450 : Part 1 : Sec 10 : 2019	Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers	MHD 15

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Diagnostic Instruments
Sub Sub Group	:	Surgical, Diagnostic equipment and General safety requirements
Aspect	:	Others
Certification	:	Not Certifiable
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:
Degree of Equivalence	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	IEC 60601-1-10:2020
Harmonized with	:	IEC

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS 13450 : Part 1 : Sec 10 : 2024

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

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Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 6

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS 13450 : Part 1 : Sec 10 : 2024

List of Expired or Cancelled Licenses under IS : IS 13450 : Part 1 : Sec 10 : 2024

List of laboratories for : IS 13450 : Part 1 : Sec 10 : 2024

List of Amendement(s) for : IS 13450 : Part 1 : Sec 10 : 2024

List of Gazette Document(s) for : IS 13450 : Part 1 : Sec 10 : 2024

List of Corigenda Document(s) for : IS 13450 : Part 1 : Sec 10 : 2024

List of Product Manuals & SIT