Indian Standard Details

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IS Number : IS 18298 : 2023
ISO 17593 : 2022

IS Title [Eng-Hn] : Clinical Laboratory Testing and in Vitro Medical Devices Requirements for in Vitro Monitoring Systems for Self-Testing of Oral Anticoagulant Therapy First Revision
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 10 ( Medical Laboratory Instruments )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group : Biological tests
Aspects: Code of Practice
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title: oral anticoagulant therapy
Itchs: N/A
Degree of Equivalence: Identical under dual numbering
Identical/Equivalent Standards:ISO 17593 : 2022
Organisation :

Indian Standards Refered In IS IS 18298 : 2023 :
SNo IS Number Title Technical Committee
1
IS/ISO 13485 : 2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) MHD 14
2
IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices First Revision MHD 14
3
IS/ISO 15198 : 2004 Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer MHD 19
4
IS/ISO 17511 : 2020 In Vitro Diagnostic Medical Devices - Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials and Human Samples MHD 19
5
IS/ISO 23640 : 2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents MHD 19
6
IS 13450 : Part 1 : SEC 2 : 2018 Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision) MHD 15
7
IS 14700 : Part 4 : Sec 2 : 2018 Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 2 electrostatic discharge immunity test (Second Revision) LITD 9
8
IS/ISO 14065 : 2013 Greenhouse gases - Requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition (First Revision) EED 1
9
IS 9877 : 1981 Code of Practice for Installation, Operation and Preventive Maintenance of Grain Combine FAD 11
10
IS B2997 : 1964 Specification for air circulator type electric fans and regulators ETD 32
11
IS 9879 : 1998 Method for emission spectrometric analysis of austenitic and ferritic stainless steels point to plane technique (First Revision) MTD 34
International Standards Refered In IS 18298 : 2023
SNo International Standard Number
1 0 0 : 0 : 0 0
2 ISO 9000 : 2015
3 ISO 9000 : 2015
4 ISO 0 : 0 : 0 0
5 ISO 9000 : 2015
6 ISO 9000 : 2015
7 ISO 0 : 0 : 0 0
8 ISO 9000 : 2015
9 ISO 9000 : 2015
10 ISO 15000 : 2015
11 ISO 0 : 0 : 0 0
12 ISO 9000 : 2015
13 ISO 0 : 0 : 0 0
IS 18298 : 2023 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.