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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 19193 : 2025

IS Title/आईएस शीर्षक : Non-Active Surgical Implants ï¿½ Joint Replacement Implants ï¿½ Specific Requirements for Knee-Joint Replacement Implants

Superseding IS/सुपरसीडिंग आईएस : IS/ISO 21536 : 2007

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Product Specification

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 02 (Orthopedic Instruments, Implants and Accessories Sectional Committee)

Member Secretary/सदस्य सचिव : Mr. VINIT VIDYADHAR BANSOD (SCIENTIST-C)

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 19193 : 2025
:

1	IS 18074 : Part 1 : 2023	Implants for surgery - Ultra-high-molecular-weight polyethylene Part 1 Powder form	MHD 2
2	IS 12376 (Part 1) : 2015 ISO 7207-1 : 2007 Reviewed In : 2020	Implants for surgery - Components for partial and total knee joint prostheses Part 1 classification, definitions and designation of dimensions (Second Revision)	MHD 2
3	IS 18852 (Part 1) : 2024 ISO 7755-1:2013	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)	MHD 19
4	IS 18879 (Part 12) : 2024 ISO 8536-12:2021	Implants for surgery - Wear of total knee-joint prostheses Part 1 Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test	MHD 2
5	IS 18815 : 2024	Implants for surgery - Wear of total knee-joint prostheses Part 2 Methods of measurement	MHD 2
6	IS 18879 (Part 13) : 2024 ISO 8536-13:2016	Implants for surgery - Wear of total knee-joint prostheses Part 3 Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test	MHD 2
7	IS 18076 : 2023	Non-active surgical implants - General requirements	MHD 2
8	IS 18982 : 2024 ISO/TR 24119:2015	Implants for surgery - Total knee-joint prostheses Part 1 Determination of endurance properties of knee tibial trays	MHD 2
9	IS/ISO 21534 : 2007 ISO 21534 : 2007 Reviewed In : 2023	Non - Active surgical implants - Joint replacement implants - Particular requirements	MHD 2
10	IS 233 (Part 2) : 2021	Tool holders for internal turning with cylindrical shank for indexable inserts: Part 5 Style U	PGD 32
11	IS/IEC 62037-4 : 2012 IEC 62037-4: 2012 Reviewed In : 2024	Hexagon head screws with metric fine pitch thread Product grades A and B Second Revision of IS 13725 ICS 2106010	PGD 37

International Standards Referred In IS 19193 : 2025

Standard contains no Cross Referenced International Standard.

IS 19193 : 2025
is Referred in following Indian Standards :

1	IS/IEC 61968 : Part 3 : 2021	Application integration at electric utilities System interfaces for distribution management Part 3: Interface for network operations	LITD 10
2	IS 12640 : Part 1 : 2016	Residual current operated circuitBreakers without integral overcurrent protection for household and similar uses (Rccbs): Part 1 general rules (Second Revision)	ETD 7
3	IS 2993 : 1998	A.C. motor capacitors (Second Revision)	ETD 29
4	IS/IEC 60695 : Part 2 : Sec 10 : 2021	Fire hazard testing Part 2: Glowinghot-wire based test methods Section 10: Glow-wire apparatus and common test procedure	LITD 1
5	IS/IEC 60695 : Part 2 : Sec 10 : 2021	Fire hazard testing Part 2: Glowinghot-wire based test methods Section 10: Glow-wire apparatus and common test procedure	LITD 1

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Implants
Sub Sub Group	:	Orthopaedic Implants
Aspect	:	Product Specification
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare - Department of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:	Requirements for Knee-Joint Replacement Implants
ITC-HS Code	:	N/A
Degree of Equivalence	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	ISO 21536 : 2023
Harmonized with	:	ISO

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3	Additional mailing list	Download

List of Licenses under IS : IS 19193 : 2025

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 19193 : 2025

List of Expired or Cancelled Licenses under IS : IS 19193 : 2025

List of laboratories for : IS 19193 : 2025

List of Amendement(s) for : IS 19193 : 2025

List of Gazette Document(s) for : IS 19193 : 2025

List of Corigenda Document(s) for : IS 19193 : 2025

List of Product Manuals & SIT