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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 14708-1 : 2014
ISO 14708-1 : 2014
Reviewed In : 2023

IS Title/आईएस शीर्षक : Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under single numbering

Number of Revisions/पुनरीक्षणों की संख्या : 1

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Safety Standard

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : January, 2023

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

Technical Committee/तकनीकी समिति : MHD 07 (Neurosurgery Instruments Implants and Accessories Sectional Committee)

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

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 0

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 14708-1 : 2014
ISO 14708-1 : 2014
Reviewed In : 2023 :

1	IS 7900 : 2007 ISO 8601 4 Reviewed In : 2018	Data elements and interchange formats - Information interchange - Representation of dates and times (Third Revision)	MSD 5
2	IS 12572 (Part 1) : 1994 ISO 10993-1 Reviewed In : 2016	Biological Evaluation of Medical Devices - Part 1 : Guidance on Selection of Tests	MHD 19
3	IS 13450 (Part 1) : 2024	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
4	IS 12345 : 2024	Specification for vinyl acetate monomer	PCD 9
5	IS 1200 (Part 26) : 1987 Reviewed In : 2022 Reaffirmed but not taken up for revision	Method of measurement of building and civil engineering work: Part 26 acid resistant lining	CED 44

International Standards Referred In IS/ISO 14708-1 : 2014
ISO 14708-1 : 2014
Reviewed In : 2023

1	IEC 60068 : 2 : 14 2009
2	IEC 60068 : 2 : 27 2008
3	IEC 60068 : 2 : 47 2005
4	IEC 60068 : 2 : 64 2008
5	IEC 62304 : 2006

IS/ISO 14708-1 : 2014
ISO 14708-1 : 2014
Reviewed In : 2023 is Referred in following Indian Standards :

1	IS/ISO 14708 : Part 1 : 2014	Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)	MHD 7
2	IS/ISO 14708 : Part 1 : 2014	Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)	MHD 7
3	IS/ISO 14708 : Part 2 : 2012	Implants for surgery - Active implantable medical devices: Part 2 cardiac pacemakers	MHD 15
4	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
5	IS/IEC 61020 : Part 1 : 2019	Electromechanical switches for use in electrical and electronic equipment Part 1: Generic specification	LITD 3
6	IS 17663 : 2021	Water Reuse in Urban Areas Guidelines for Water Reuse Safety Evaluation Assessment Parameters and Methods	EED 2
7	IS/ISO 18841 : 2018	INTERPRETING SERVICES - GENERAL REQUIREMENTS AND RECOMMENDATIONS	SSD 9

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Surgical instruments and accessories
Sub Sub Group	:	General surgery Instruments
Aspect	:	Safety Standard
Certification	:	Voluntary Certification
Relevant Ministries	:
Sustainable development Goals :
Short Commom Man's Title	:	General requirements for safety, marking etc for Active implantable medical devices
ITC-HS Code	:
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	ISO 14708-1:2014
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 14708 : Part 1 : 2014

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 : 0

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/ISO 14708 : Part 1 : 2014

List of Expired or Cancelled Licenses under IS : IS/ISO 14708 : Part 1 : 2014

List of laboratories for : IS/ISO 14708 : Part 1 : 2014

List of Amendement(s) for : IS/ISO 14708 : Part 1 : 2014

List of Gazette Document(s) for : IS/ISO 14708 : Part 1 : 2014

List of Corigenda Document(s) for : IS/ISO 14708 : Part 1 : 2014

List of Product Manuals & SIT