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Indian Standard Details

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Basic Details
IS Number : IS/ISO 10993-1 : 2009
ISO 10993-1 : 2009

IS Title [Eng-Hn] : Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 19 ( In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group : Biological tests
Aspects: Methods of tests
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 10993-1 : 2009
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 10993 : Part 1 : 2009 :
SNo IS Number Title Technical Committee
1
IS/ISO 10993 : Part 5 : 2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity MHD 19
2
IS 10016 : Part 1 : 1981 Methods of test for polybutadiene rubbers: Part 1 method of taking out test portions from sample bales PCD 29
3
IS 10373 : 1982 Specification for plastic boxes for safety matches CHD 26
4
IS 10375 : 1982 Specification for poker PGD 34
5
IS 10377 : 1982 Specification for para - Phenylenediamine PCD 19
6
IS 11140 : 1984 Specification for footrest assembly for mopeds TED 6
7
IS 11159 : Part 2 : 1989 Classification of lubricants industrial oils and related products: Part 2 family a (Total Loss Systems) PCD 25
8
IS 11159 : Part 3 : 1989 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 Dimensions of non - Insulated terminal tags for electronic equipment: Part 1 type 1 LITD 3
10
IS 11162 : Part 2 : 1985 Dimensions of non - Insulated terminal tags for electronic equipment: Part 2 type 2 LITD 3
11
IS 1200 : Part 28 : 1992 Method of building and civil engineering works: Part 28 sound insulation work CED 44
12
IS 12280 : 1988 Specification for tenon without counterbore PGD 35
13
IS 12281 : 1988 Mounting dimensions of machine tool doors with hinges PGD 35
14
IS 12284 : 1988 Specification for prepreg for ruse in multilayer printed boards LITD 5
15
IS 12285 : 2018 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 Method for determination of abrasive wear resistance of hardmetals MTD 25
17
IS 12287 : 1988 Specification for consolidometer for determination of consolidation properties CED 43
18
IS 12289 : 1988 Specification for hand held electric engraving tools ETD 32
International Standards Refered In IS/ISO 10993 : Part 1 : 2009 Standard contains no Cross Referenced International Standard.
IS/ISO 10993 : Part 1 : 2009 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
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 — 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