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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 15676 : 2016
ISO 15676 : 2016

IS Title/आईएस शीर्षक : Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation ECMO 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 : 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 06 (Medical and Surgical Cardiology Equipment Sectional Committee)

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

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 2

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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 15676 : 2016
ISO 15676 : 2016
:

1	IS 13360 (Part 5/Sec 1) : 2021 ISO 527-1: 2019	Plastics - Methods of testing: Part 5 mechanical properties section 1 determination of tensile properties - General requirements (First Revision)	PCD 27
2	IS 13360 (Part 5/Sec 22) : 2017 ISO 9395 : 2012 Reviewed In : 2022	Plastics - Methods of testing: Part 5 mechanical properties section 22 determination of resistance to wear by abrasive wheels (First Revision)	PCD 27
3	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
4	IS 10377 : 2024	Specification for para - Phenylenediamine	PCD 19
5	IS 10016 (Part 1) : 1981 Reviewed In : 2019 Reaffirmed but not taken up for revision	Methods of test for polybutadiene rubbers: Part 1 method of taking out test portions from sample bales	PCD 29
6	IS 12334 : 1988 Reviewed In : 2023	Specification for Tractor Mounted Bund Former	FAD 11
7	IS 12340 : 1988 Reviewed In : 2021	Specification for round open top aluminium containers for liquid pesticides	PGD 38
8	IS 12342 (Part 1) : 1988 Reviewed In : 2020	Specification for raw seaweeds: Part 1 agarophytes	FAD 8
9	IS 12345 : 2024	Specification for vinyl acetate monomer	PCD 9
10	IS 12347 : 1988 Reviewed In : 2018	Analysis of means - A graphical procedure	MSD 3

International Standards Referred In IS/ISO 15676 : 2016
ISO 15676 : 2016

1	ISO 527 : 1 : 2012
2	ISO 9352 : 2012
3	ISO 10993 : 1 : 2009
4	ISO 10993 : 7 : 2008
5	ISO 11135 : 2014
6	ISO 11137 : 1 : 2006
7	ISO 11137 : 2 : 2013
8	ISO 11607 : 1 : 2006
9	ISO 11607 : 2 : 2006
10	ISO 34 : 1 : 2010
11	ISO 10993 : 11 : 2017
12	ISO 17665 : 1 : 2006
13	ISO 14937 : 2009
14	ASTM 0 : 2000
15	ASTM 0 : 4 : 2004

IS/ISO 15676 : 2016
ISO 15676 : 2016
is Referred in following Indian Standards :

1	IS/ISO 15676 : 2005	Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO)	MHD 6
2	IS/ISO 15676 : 2005	Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO)	MHD 6
3	IS/ISO 15676 : 2005	Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO)	MHD 6
4	IS/ISO 15676 : 2005	Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO)	MHD 6
5	IS/ISO 15676 : 2005	Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO)	MHD 6
6	IS/ISO 15676 : 2005	Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO)	MHD 6
7	IS/ISO 15676 : 2005	Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO)	MHD 6

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Implants
Sub Sub Group	:	Cardiovascular surgery instrument and implants
Aspect	:	Product Specification
Certification	:	Voluntary Certification
Relevant Ministries	:
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	ISO 15676 : 2016
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 15676 : 2016

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 : 2

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 15676 : 2016

List of Expired or Cancelled Licenses under IS : IS/ISO 15676 : 2016

List of laboratories for : IS/ISO 15676 : 2016

List of Amendement(s) for : IS/ISO 15676 : 2016

List of Gazette Document(s) for : IS/ISO 15676 : 2016

List of Corigenda Document(s) for : IS/ISO 15676 : 2016

List of Product Manuals & SIT