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IS Number/आईएस संख्या : IS/ISO 10451 : 2010
ISO 10451:2010

IS Title/आईएस शीर्षक : Dentistry Contents of technical file for dental implant systems

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under single 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 08 (Dentistry Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. HARSHADA GANESH KADAM (SCIENTIST-B)

QCO Notified & Under Implementation
Implementation Date::17-04-2025

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/ISO 10451 : 2010
ISO 10451:2010
:

1	IS/ISO 7405 : 2008 ISO 7405 : 2008	Dentistry - Evaluation of biocompatibility of medical devices used in dentistry	MHD 19
2	IS/ISO 10993-1 : 2009 ISO 10993-1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
3	IS/ISO 10993-7 : 2018 ISO 10993-7 : 2008	Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals	MHD 19
4	IS/ISO 10993-9 : 2009 ISO 10993-9 : 2009	Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products	MHD 19
5	IS/ISO 11135 : 2014 ISO 11135 : 2014	Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices	MHD 12
6	IS/ISO 11137-1 : 2006 ISO 11137-1 : 2006	Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices	MHD 12
7	IS 11137 (Part 2) : 2012 IEC 60812: 2006 Reviewed In : 2019	Analysis techniques for system reliABility: Part 2 procedure for failure mode and effects analysis (Fmea) (First Revision)	LITD 2
8	IS/ISO 11137-3 : 2017 ISO 11137-3 : 2017	Sterilization of Health Care Products â€• Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control	MHD 12
9	IS/ISO 14155 : 2020 ISO 14155: 2020	Clinical investigation of medical devices for human subjects - Good clinical practice	MHD 19
10	IS/ISO 14971 : 2019 ISO 14971:2019	Medical devices - Application of risk management to medical devices	MHD 14
11	IS 10360 : 1982 Reviewed In : 2024	Lime-pozzolana Concrete Blocks For Paving	CED 4
12	IS 7155 (Part 7) : 2023	Code of recommended practice for conveyor safety: Part 7 inspection and maintenance (First Revision)	MED 6
13	IS 7155 (Part 8) : 2023	Code of recommended practice for conveyor safety: Part 8 flight conveyors (Scraper Conveyors) (First Revision)	MED 6

International Standards Referred In IS/ISO 10451 : 2010
ISO 10451:2010

1	ISO 129 : 1 : 0 0
2	ISO 8601 : 0 : 0 0
3	ISO 14405 : 2 : 0 0
4	ISO 14801 : 0 : 0 0
5	ISO 14937 : 0 : 0 0
6	ISO 17664 : 0 : 0 0
7	ISO 17665 : 1 : 0 0

IS/ISO 10451 : 2010
ISO 10451:2010
is Referred in following Indian Standards :

1	IS 12725 : 2021	Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision )	PGD 36
2	IS 12725 : 2021	Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision )	PGD 36
3	IS 12725 : 2021	Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision )	PGD 36
4	IS 15475 : Part 3 : 2004	Code of recommended practice for amusement rides safety: Part 3 design, manufacture and erection	MED 6
5	IS/ISO/IEC/TR 12785 : Part 3 : 2012	Information technology - Learning education and training - Content packaging Part 3: Best practice and implementation guide	LITD 19
6	IS 17253 : Part 1 : 2019	Machine Tools Safety â€” Machining Centres, Milling Machines, Transfer Machines Part 1 Safety Requirements	PGD 35
7	IS/ISO/IEC 2382 : PART 36 : 2019	Information technology - Vocabulary Part 36: Learning education and training	LITD 19
8	IS 15097 : 2002	Pneumatic fluid power - Cylindrical quick - Action couplings for maximum working pressures of 10 bar, 16 bar and 25 bar (1 Mpa, 1.6 Mpa And 2.5 Mpa) - Plug connecting dimensions, Specifications, application guidelines and testing	PGD 36

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Dentistry instruments/equipment and accessories
Sub Sub Group	:	Dental Equipments
Aspect	:	Code of Practice
Certification	:	Mandatory 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 single numbering
Identical/Equivalent International Standard(s)	:	ISO 10451:2010
Harmonized with	:	ISO

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

List of Licenses under IS : IS/ISO 10451 : 2010

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

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List of Licenses under IS : IS/ISO 10451 : 2010

List of Expired or Cancelled Licenses under IS : IS/ISO 10451 : 2010

List of laboratories for : IS/ISO 10451 : 2010

List of Amendement(s) for : IS/ISO 10451 : 2010

List of Gazette Document(s) for : IS/ISO 10451 : 2010

List of Corigenda Document(s) for : IS/ISO 10451 : 2010

List of Product Manuals & SIT