Indian_standards - BIS Connect

Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18298 : 2023
ISO 17593 : 2022

IS Title/आईएस शीर्षक : Clinical Laboratory Testing and in Vitro Medical Devices Requirements for in Vitro Monitoring Systems for Self-Testing of Oral Anticoagulant Therapy First Revision

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under dual numbering

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Code of Practice

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 10 (Medical Laboratory Instruments Sectional Committee)

Member Secretary/सदस्य सचिव : Mr. PAWAN KUMAR (SCIENTIST-B)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 1

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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 18298 : 2023
ISO 17593 : 2022
:

1	IS/ISO 13485 : 2016	Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )	MHD 14
2	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
3	IS/ISO 15198 : 2004 ISO 15198 : 2004	Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer	MHD 19
4	IS/ISO 17511 : 2020 ISO 17511 : 2020	In Vitro Diagnostic Medical Devices - Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials and Human Samples	MHD 19
5	IS/ISO 23640 : 2011 ISO 23640 : 2011	In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents	MHD 19
6	IS 13450 (Part 1/Sec 2) : 2024	Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision)	MHD 15
7	IS 14700 (Part 4/Sec 2) : 2018 61000-4-2 : 2008 Reviewed In : 2024	Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 2 electrostatic discharge immunity test (Second Revision)	LITD 9
8	IS/ISO 14065 : 2013 ISO 14065 : 2013 Reviewed In : 2022	Greenhouse gases - Requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition (First Revision)	EED 1
9	IS 9877 : 1981 Reviewed In : 2021	Code of Practice for Installation, Operation and Preventive Maintenance of Grain Combine	FAD 11
10	IS B2997 : 1964 Reviewed In : 2016	Specification for air circulator type electric fans and regulators	ETD 32
11	IS 9879 : 1998 Reviewed In : 2021	Method for emission spectrometric analysis of austenitic and ferritic stainless steels point to plane technique (First Revision)	MTD 34

International Standards Referred In IS 18298 : 2023
ISO 17593 : 2022

Standard contains no Cross Referenced International Standard.

IS 18298 : 2023
ISO 17593 : 2022
is Referred in following Indian Standards :

1	IS 17881 : Part 1 : 2022	Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin	TXD 32
2	IS 17881 : Part 1 : 2022	Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin	TXD 32
3	IS 17881 : Part 1 : 2022	Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin	TXD 32
4	IS 17881 : Part 1 : 2022	Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin	TXD 32

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group	:	Biological tests
Aspect	:	Code of Practice
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:	oral anticoagulant therapy
ITC-HS Code	:	N/A
Degree of Equivalence	:	Identical under dual numbering
Identical/Equivalent International Standard(s)	:	ISO 17593 : 2022
Harmonized with	:	ISO

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

List of Licenses under IS : IS 18298 : 2023

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 : 1

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 18298 : 2023

List of Expired or Cancelled Licenses under IS : IS 18298 : 2023

List of laboratories for : IS 18298 : 2023

List of Amendement(s) for : IS 18298 : 2023

List of Gazette Document(s) for : IS 18298 : 2023

List of Corigenda Document(s) for : IS 18298 : 2023

List of Product Manuals & SIT