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Indian Standard Details

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Basic Details
IS Number : IS 19071:2025
IS Title [Eng-Hn] : Instruments for Use in Association with Non-Active Surgical Implants - General Requirements
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 2 ( Orthopedic Instruments, Implants and Accessories )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Implants
Sub Sub Group : Orthopaedic Implants
Aspects: Product Specification
Certification:
Ministry : Ministry of Health and Family Welfare - Department of Health and Family Welfare
Short Commom Man's Title: Instruments for Use in Association with Non-Active Surgical Implants
Itchs: N/A
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:ISO 16061: 2021
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS 19071 : 2025 :
SNo IS Number Title Technical Committee
1
IS/ISO 8601 : Part 1 : 2019 Date and Time Representations For Information Interchange Part 1: Basic Rules MSD 5
2
IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
3
IS/ISO 11135 : 2014 Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices MHD 12
4
IS/ISO 11137 : Part 1 : 2006 Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices MHD 12
5
IS/ISO 11137 : Part 2 : 2013 Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose MHD 12
6
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
7
IS/ISO 11607 : Part 1 : 2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision MHD 12
8
IS/ISO 11607 : Part 2 : 2019 Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision) MHD 12
9
IS/ISO 14155 : 2020 Clinical investigation of medical devices for human subjects - Good clinical practice MHD 19
10
IS/ISO 14937 : 2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices MHD 12
11
IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices First Revision MHD 14
12
IS 18319 : Part 1 : 2023 Sterilization of health care products Moist heat Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices MHD 12
13
IS/ISO 80000 : Part 1 : 2022 Quantities and Units Part 1 General PGD 1
International Standards Refered In IS 19071 : 2025 Standard contains no Cross Referenced International Standard.
IS 19071 : 2025 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.