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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 10993-1 : 2009
ISO 10993-1 : 2009

IS Title/आईएस शीर्षक : Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process (Withdrawn)

Superseded by IS/प्रतिस्थापित आईएस : IS 17932 (Part 1):2023

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 : Methods of tests

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 19 (In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. NAGAVARSHINI M (SCIENTIST-C)

Other Details

Gazette Document : 2

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Classification details for: IS/ISO 10993 : Part 1 : 2009

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Cross Reference Details

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Cross Reference Details

Indian Standards Referred In IS IS/ISO 10993-1 : 2009
ISO 10993-1 : 2009
:

1	IS/ISO 10993-5 : 2009 ISO 10993-5 : 2009	Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity	MHD 19
2	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
3	IS 10373 : 1982 Reviewed In : 2021	Specification for plastic boxes for safety matches	CHD 26
4	IS 10375 : 1982 Reviewed In : 2021	Specification for poker	PGD 34
5	IS 10377 : 2024	Specification for para - Phenylenediamine
6	IS 11140 : 2024	Specification for footrest assembly for mopeds	TED 6
7	IS 11159 (Part 2) : 2021	Classification of lubricants industrial oils and related products: Part 2 family a (Total Loss Systems)	PCD 25
8	IS 11159 (Part 3) : 2021	Classification of lubricants, industrial oils and related products: Part 3 family f (Spindle Bearings, Bearings And Associated Clutches)	PCD 25
9	IS 11162 (Part 1) : 1985 Reviewed In : 2019	Dimensions of non - Insulated terminal tags for electronic equipment: Part 1 type 1	LITD 3
10	IS 11162 (Part 2) : 1985 Reviewed In : 2019	Dimensions of non - Insulated terminal tags for electronic equipment: Part 2 type 2	LITD 3
11	IS 1200 (Part 28) : 1992 Reviewed In : 2022 Reaffirmed but not taken up for revision	Method of building and civil engineering works: Part 28 sound insulation work	CED 44
12	IS 12280 : 1988 Reviewed In : 2019 Reaffirmed but not taken up for revision	Specification for tenon without counterbore	PGD 35
13	IS 12281 : 1988 Reviewed In : 2019 Reaffirmed but not taken up for revision	Mounting dimensions of machine tool doors with hinges	PGD 35
14	IS 12284 : 1988 Reviewed In : 2020	Specification for prepreg for ruse in multilayer printed boards	LITD 5
15	IS 12285 : 2018 ISO/IEC 7480 : 1991 Reviewed In : 2023	Information technology - Telecommunications and information exchange between systems - Start - Stop transmission signal quality at DTE/DCE interfaces (First Revision)	LITD 13
16	IS 12286 : 1988 Reviewed In : 2024	Method for determination of abrasive wear resistance of hardmetals	MTD 25
17	IS 12287 : 1988 Reviewed In : 2020	Specification for consolidometer for determination of consolidation properties	CED 43
18	IS 12289 : 1988 IEC 60745-1 Reviewed In : 2019	Specification for hand held electric engraving tools	ETD 32

International Standards Referred In IS/ISO 10993-1 : 2009
ISO 10993-1 : 2009

1	ISO 14971 : 0 : 0 0

IS/ISO 10993-1 : 2009
ISO 10993-1 : 2009
is Referred in following Indian Standards :

1	IS/ISO 15223 : Part 2 : 2010	Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation	MHD 14
2	IS/ISO 15674 : 2016	Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision)	MHD 6
3	IS/ISO 25539 : Part 1 : 2017	Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)	MHD 6
4	IS/ISO 7198 : 2016	Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches	MHD 6
5	IS/ISO 12417 : Part 1 : 2015	Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements	MHD 6
6	IS/ISO 15675 : 2016	Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters	MHD 6
7	IS/ISO 18241 : 2016	Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps	MHD 6
8	IS/ISO 18242 : 2016	Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps	MHD 6
9	IS 5405 : 2019	Sanitary napkins – Specification (second revision)	TXD 36
10	IS/ISO 5840 : Part 2 : 2015	Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes	MHD 6
11	IS/ISO 5840 : Part 3 : 2013	Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques	MHD 6
12	IS/ISO 8637 : Part 1 : 2017	Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators	MHD 6
13	IS/ISO 8637 : Part 2 : 2018	Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters	MHD 6
14	IS/ISO 8637 : Part 3 : 2018	Extracorporeal Systems for Blood Purification Part 3 Plasmafilters	MHD 6
15	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
16	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
17	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
18	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
19	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
20	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
21	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
22	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
23	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
24	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
25	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
26	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
27	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
28	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
29	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
30	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
31	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
32	IS 12725 : 2021	Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision )	PGD 36
33	IS 10654 : 2018	Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision)	MHD 12
34	IS/ISO 27427 : 2013	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components	MHD 11
35	IS/IEC 60071 : Part 1 : 2006	Insulation Co-ordination Part 1 Definitions, Principles and Rules	ETD 19
36	IS/ISO 6016 : 2008	Earth-Moving Machinery â€” Methods of Measuring the Masses of Whole Machines, their Equipment and Components	MED 7
37	IS 5402 : Part 1 : 2021	Microbiology of the food chain - Horizontal method for the enumeration of microorganisms- Part 1: Colony count at 30 C by the pour plate technique	FAD 31
38	IS 17545 : 2021	White cement based polymeric putty	CHD 20
39	IS 3025 : Part 71 : 2021	Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 71 Determination of Dissolved Cations Using Ion Chromatography	CHD 36
40	IS/ISO 5971 : 2017	Textiles Size designation of clothes Tights	TXD 20
41	IS 16143 : Part 6 : 2021	Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision)	PCD 7
42	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
43	IS 14147 : Part 1 : 2021	Identification Cards Recording Technique Part 1 Embossing	LITD 16
44	IS 229 : 2021	Ethyl acetate - Specification (Fourth Revision)	PCD 9
45	IS 101 : Part 2 : Sec 4 : 2022	Methods of sampling and test for paints varnishes and related products: Part 2 test on liquid paints chemical examination : Sec 4 determination of volatile organic compound voc and or semi volatile organic compounds svoc content gas-chromatographic (First Revision)	CHD 20

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group	:	Biological tests
Aspect	:	Methods of tests
Certification	:	None
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 10993-1 : 2009
Harmonized with	:

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

List of Licenses under IS : IS/ISO 10993 : Part 1 : 2009

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

Know your standards

Basic Details/ मूल ब्यौरा

Other Details

Gazette Document : 2

Classification details for: IS/ISO 10993 : Part 1 : 2009

Cross Reference Details

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS/ISO 10993 : Part 1 : 2009

List of Expired or Cancelled Licenses under IS : IS/ISO 10993 : Part 1 : 2009

List of laboratories for : IS/ISO 10993 : Part 1 : 2009

List of Amendement(s) for : IS/ISO 10993 : Part 1 : 2009

List of Gazette Document(s) for : IS/ISO 10993 : Part 1 : 2009

List of Corigenda Document(s) for : IS/ISO 10993 : Part 1 : 2009

List of Product Manuals & SIT