Document Details |
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| Name of Department/Committee : | MHD 14 |
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| Document Number : | MHD 14 ( 23491) |
| Document Title [English] : | Medical devices Information to be supplied by the manufacturer |
| Document Title [Hindi] : | चिकित्सा उपकरण - निर्माता द्वारा आपूर्ति की जाने वाली जानकारी |
| Document Type : | New |
| Language : | English |
| Priority : | 1 |
| ICS Code : | 11.040.01 |
| Date of Project Approval : | 15-06-2023 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Medical and Hospital Equipments |
| Sub Sub Group : | Allied hospital equipment |
| Aspects : | Code of Practice |
| Risk : | Medium |
| Certification : | Not Certifiable |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Identical under single numbering |
| Identical/Equivalent Standards : | ISO 20417:2021 |
| Organization Type: | ISO |
Division Council Chairperson Approval Details |
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::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | IS 14836 : Part 1: 2020 | Codes for the Representation of Names of Countries and their Subdivisions Part 1 Country Codes ( Second Revision ) | |
| 2 | IS 16449 : Part 1: 2018 | Graphical symbols - Safety colours and safety signs: Part 1 design principles for safety signs and safety markings | |
| 3 | IS 16450 : 2023 | Graphical Symbols for Use on Equipment Registered Symbols | |
| 4 | IS 16451 : 2023 | Graphical Symbols Safety Colours and Safety Signs Registered Safety Signs | |
| 5 | IS/ISO 8601 : Part 1: 2019 | Date and Time Representations For Information Interchange Part 1: Basic Rules | |
| 6 | IS/ISO 13485: 2016 | Medical Devices Quality Management Systems Requirements for Regulatory Purposes ( First Revision ) | |
| 7 | IS/ISO 14971 : 2019 | Medical devices - Application of risk management to medical devices First Revision | |
| 8 | IS 18105 : Part 1: 2023 | Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements | |
| 9 | IS/ISO 16142 : Part 1: 2016 | Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards | |
| 10 | IS/ISO 16142 : Part 2: 2017 | Medical devices - Recognized essential principles of safety and performance of medical devices: Part 2 General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards | |
| 11 | IS 16450 : 2023 | Graphical Symbols for Use on Equipment Registered Symbols | |
| 12 | IS/ISO 80000 : Part 1: 2022 | Quantities and Units Part 1 General | |
| Sl. No. | Document No | Document Title | |
| 1 | MHD/14 / 20106 | Medical Devices Part 1: Application of Usability Engineering | |
| Sl.No. | Synosis Points | |
| 1 | This document provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. The aim of this document is to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices. The requirements of a medical device product standard or a group standard can make use of these general requirements. Where there is a conflict and a product standard or a group standard exists, this document should not be used separately. Specific requirements of medical device product standards or group standards take precedence over requirements of this document. Unless specified otherwise within a product standard or a group standard, the general requirements of this document apply. | |
Timeline Details |
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