Document Details |
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| Name of Department/Committee : | MHD 03 |
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| Document Number : | MHD 03 ( 23553) |
| Document Title [English] : | Female condoms Use of ISO 25841 and the quality management of female condoms |
| Document Title [Hindi] : | महिला कंडोम — आईएसओ 25841 का उपयोग और महिला कंडोम का गुणवत्ता प्रबंधन |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.200 |
| Date of Project Approval : | 11-09-2023 |
| Standards to be Superseded : | |
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 : | Code of Practice |
| Risk : | Medium |
| 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 : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO/TR 24484: 2023 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | IS 2500 : Part 1: 2000 | Sampling procedures for inspection by attributes: Part 1 sampling schemes indexed by acceptance quality limit (AQL) for lot - By - Lot inspection (Third Revision) | |
| 2 | IS/ISO 9000: 2015 | Quality management systems - Fundamentals and vocabulary (Fourth Revision) | |
| 3 | IS/ISO 13485: 2016 | Medical Devices Quality Management Systems Requirements for Regulatory Purposes ( First Revision ) | |
| 4 | IS/ISO 14971 : 2019 | Medical devices - Application of risk management to medical devices First Revision | |
| 5 | IS/ISO/IEC 17025: 2017 | General requirements for the competence of testing and calibration laboratories (Second Revision) | |
| 6 | IS 17962 : 2022 | Female condoms - Requirements and test methods (First Revision) | |
| 7 | IS/ISO 29943 : Part 2: 2017 | Condoms Guidance on clinical studies Part 2: Female condoms clinical function studies based on self-reports | |
| Sl.No. | Synosis Points | |
| 1 | This document is a document providing manufacturers, buyers, regulatory agencies and third-party test laboratories, information relating to implementation and application of ISO 25841 and ISO 13485 in the quality management for manufacture of female condoms, and for purchasers to develop appropriate purchase technical specifications and to verify that condoms delivered comply with requirements of ISO 25841 and ISO 13485. | |
| 2 | This document outlines the importance of the requirements of the quality management system based on ISO 13485 that are applied during all the stages of design and development, production, supply, procurement, and post- production related to the complete life cycle of female condoms. | |
Timeline Details |
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