Document Details |
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| Name of Department/Committee : | MHD 08 |
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| Document Number : | MHD 08 ( 28020) |
| Document Title [English] : | Dentistry General Requirements for Instruments and Related Accessories Used in Dental Implant Placement and Treatment |
| Document Title [Hindi] : | दंत चिकित्सा — दंत इम्प्लांट स्थापना और उपचार में उपयोग किए जाने वाले उपकरणों और संबंधित सहायक उपकरणों के लिए सामान्य अपेक्षाएँ |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.060.25 |
| Date of Project Approval : | 08-05-2025 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Dentistry instruments/equipment and accessories |
| Sub Sub Group : | Dental instruments |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : | |
| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 13504:2012 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This International Standard specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. | |
| 2 | It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. | |
| 3 | It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. | |
| 4 | With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer. | |
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