Indian Standard Details

    Print

IS Number : IS/ISO 13485 : 2016


IS Title [Eng-Hn] : Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )
No of Revision : 1
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 14 ( Hospital Planning )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Medical and Hospital Equipments
Sub Sub Group : Allied hospital equipment
Aspects: System Standard
Certification:
Ministry :
Short Commom Man's Title: Medical devices-Quality management systems- Requirements for regulatory purposes
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 13485:2016
Organisation :

Indian Standards Refered In IS IS/ISO 13485 : 2016 :
SNo IS Number Title Technical Committee
Standard contains no Cross Referenced Indian Standard.
Standard contains no Cross Referenced Indian Standard.
International Standards Refered In IS/ISO 13485 : 2016 Standard contains no Cross Referenced International Standard.
IS/ISO 13485 : 2016 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 13022 : 2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices MHD 19
2 IS/ISO 25539 : Part 1 : 2017 Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision) MHD 6
3 IS/ISO 11137 : Part 3 : 2017 Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control MHD 12
4 IS/ISO 13485 : 2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) MHD 14
5 IS/ISO 15198 : 2004 Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer MHD 19
6 IS 3565 : 1966 Rubber Teats for Feeding Bottles PCD 13
7 IS/ISO 6016 : 2008 Earth-Moving Machinery — Methods of Measuring the Masses of Whole Machines, their Equipment and Components MED 7
8 IS 16143 : Part 6 : 2021 Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision) PCD 7
9 IS 17652 : 2021 Soy Butter FAD 16
10 IS 17591 : 2021 Guideline for the system design of HVDC converter stations with line-commutated converters ETD 40
11 IS 16048 : Part 2 : 2021 SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES SECONDARY SEALED CELLS AND BATTERIES FOR PORTABLE APPLICATIONS PART 2: NICKEL-METAL HYDRIDE ETD 11
12 IS 729 : 2021 DRAWER LOCKS CUPBOARD LOCKS AND BOX LOCKS - SPECIFICATION MED 33
13 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
14 IS 14473 : Part 3 : 2022 CRANES INSPECTIONS -- PART 3 TOWER CRANES MED 14
15 IS 15748 : 2022 Protective clothing - Clothing to protect against heat and flame - Minimum performance requirements (first revision) TXD 32
16 IS 17847 : 2022 Bensulfuron Methyl technical- Specification FAD 1
17 IS 17881 : Part 1 : 2022 Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin TXD 32
18 IS 1885 : Part 84 : 2022 Electrotechnical Vocabulary Part 84 Terminology Concerning Fire Tests for Electrotechnical Products (Third Revision) LITD 1
19 IS 3025 : Part 18 : 2022 Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 18 Volatile and Fixed Solids (Total, Filterable and Non-Filterable at 550 C (Second Revision) CHD 36
20 IS 11047 : 2022 TEXTILES POSTAL GREEN CASH BAGS SPECIFICATION TXD 20
21 IS 17883 : 2022 Geological Exploration for Tunnels Guidelines WRD 5
22 IS 17960 : 2022 Dentistry Coiled springs for use in orthodontics MHD 8
23 IS/IEC 62488 : Part 3 : 2021 Power line communication systems for power utility applications Part 3: Digital Power Line Carrier DPLC Terminals and hybrid ADPLC Terminals LITD 10