Document Details |
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| Name of Department/Committee : | MHD 03 | ||||
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| Document Number : | MHD 03 ( 23554) | ||||
| Document Title [English] : | Copper-bearing Contraceptive Intrauterine Devices Requirements and Tests Second Revision | ||||
| Document Title [Hindi] : | कॉपर-युक्त गर्भनिरोधक अंतर्गर्भाशयी उपकरण - अपेक्षाएं और परीक्षण (दूसरा पुनरीक्षण) | ||||
| Document Type : | Revision | ||||
| Language : | English | ||||
| Priority : | 3 | ||||
| ICS Code : | 11.200 | ||||
| Date of Project Approval : | 11-09-2023 | ||||
| Standards to be Revised : |
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| Standards to be Superseded : |
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Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Surgical instruments and accessories |
| Sub Sub Group : | Gynaecology instruments and Contraception devices |
| Aspects : | Product Specification |
| Risk : | High |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | ISO 7439: 2023 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | 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) | |
| 2 | IS/ISO 14155 : 2020 | Clinical investigation of medical devices for human subjects - Good clinical practice | |
| 3 | IS 18076 : 2023 | Non-active surgical implants - General requirements | |
| 4 | IS/ISO 14971 : 2019 | Medical devices - Application of risk management to medical devices First Revision | |
| 5 | 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) | |
| 6 | IS/ISO 14155 : 2020 | Clinical investigation of medical devices for human subjects - Good clinical practice | |
| 7 | IS 18076 : 2023 | Non-active surgical implants - General requirements | |
| 8 | IS/ISO 14971 : 2019 | Medical devices - Application of risk management to medical devices First Revision | |
::Cross Referenced International Standard(s) & Standard(s) Of National SDO(s) :: |
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| Sl. No. | Prefix | Number | Part | Section | Year | |
| 1 | ISO | 15223 | 1 | - | 2021 | |
| 2 | ASTM | 3078 | - | - | - | |
| 3 | ASTM | 1929 | - | - | - | |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. | |
| 2 | It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. | |
Timeline Details |
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