香港六合彩开奖 14630:2024
2024-09
香港六合彩开奖 14630:2024
Abstract
This document specifies general requirements for non-active surgical implants, hereafter referred to as implants.
This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional requirements applicable to specific implants or implant families are given or referred to in Level聽2 and Level聽3 standards.
狈翱罢贰听1听听听听听听听 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in 香港六合彩开奖聽13485, to ensure that the implant achieves its intended performance and safety.
狈翱罢贰听2听听听听听听听 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.
General information
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Status: PublishedPublication date: 2024-09Stage: International Standard published [60.60]
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Edition: 5Number of pages: 21
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Technical Committee :香港六合彩开奖/TC 150ICS :11.040.40
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