Document Details |
|||||
| Name of Department/Committee : | MHD 02 | ||||
|---|---|---|---|---|---|
| Document Number : | MHD 02 ( 25842) | ||||
| Document Title [English] : | Implants for Surgery Ceramic Materials Part 1: Ceramic Materials Based on High Purity Alumina First Revision | ||||
| Document Title [Hindi] : | सर्जरी के लिए प्रत्यारोपण - सिरेमिक सामग्री भाग 1: उच्च शुद्धता एल्यूमिना पर आधारित सिरेमिक सामग्री (पहला पुनरीक्षण) | ||||
| Document Type : | Revision | ||||
| Language : | English | ||||
| Priority : | 3 | ||||
| ICS Code : | 11.040.10 | ||||
| Date of Project Approval : | 18-12-2023 | ||||
| Standards to be Revised : |
|
||||
| Standards to be Superseded : | |||||
Classification Details |
|
| Group : | Medical and Hospital Equipments |
| Sub Group : | Surgical instruments and accessories |
| Sub Sub Group : | Orthopaedic surgery instruments |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Ceramic Materials Based on High Purity Alumina |
| ITCHS Code : | |
| Ministry : |
|
| Sustainable development Goals : |
|
| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 6474-1:2019 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. | |
| 2 | This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document | |
Timeline Details |
|||||||
|
|
|||||||
|
|||||||
|
|||||||
Stages |
|||||
| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 18-12-2023 | ------- | ||
| 2 | P-Draft Waived | 12-06-2024 | ------- | ||
| 3 | WC Draft | 12-06-2024 | Duration : 30 Days Submitted for HOD approval Remarks : Submitted for kind consideration |
------- | |
| 4 | WC Draft | 12-06-2024 | WC approved by HOD |
MHDC MHD 02, | ------- |