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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18076 : 2023
ISO 14630: 2012

IS Title/आईएस शीर्षक : Non-active surgical implants - General requirements

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 : 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 18076 : 2023
ISO 14630: 2012
:

1	IS/ISO 8601 : Part 1 : 2019	Date and Time Representations For Information Interchange Part 1: Basic Rules	MSD 5
2	IS/ISO 11137-2 : 2013 ISO 11137-2 : 2013	Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose	MHD 12
3	IS 17630 : 2021	Packaging for terminally sterilized medical devices â€” Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision	MHD 12
4	IS/ISO 14937 : 2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices	MHD 12
5	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
6	IS/IEC 60068-2-55 : 2013 IEC 60068-2-55:2013	Medical Devices Utilizing Animal Tissues and their Derivatives Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Spongiform Encephalopathy (TSE) Agents	MHD 19

International Standards Referred In IS 18076 : 2023
ISO 14630: 2012

Standard contains no Cross Referenced International Standard.

IS 18076 : 2023
ISO 14630: 2012
is Referred in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

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
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:	N/A
Degree of Equivalence	:	Identical under dual numbering
Identical/Equivalent International Standard(s)	:	ISO 14630: 2012
Harmonized with	:	ISO

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

List of Licenses under IS : IS 18076 : 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 18076 : 2023

List of Expired or Cancelled Licenses under IS : IS 18076 : 2023

List of laboratories for : IS 18076 : 2023

List of Amendement(s) for : IS 18076 : 2023

List of Gazette Document(s) for : IS 18076 : 2023

List of Corigenda Document(s) for : IS 18076 : 2023

List of Product Manuals & SIT