11.040.40 外科植入物、假体和矫形 标准查询与下载
共找到 3138 条与 外科植入物、假体和矫形 相关的标准，共 210 页
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
- ICS
- 11.040.40
- CCS
- 发布
- 2023-06
- 实施
- 2023-06
Orthotics — Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses
- ICS
- 11.040.40
- CCS
- 发布
- 2023-06
- 实施
- 2023-06
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
- ICS
- 11.040.40
- CCS
- 发布
- 2023-06
- 实施
- 2023-06
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
- ICS
- 11.040.40
- CCS
- 发布
- 2023-06
- 实施
BS ISO 8637-3. Extracorporeal systems for blood purification - Part 3. Plasmafilters
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-17
- 实施
- 2023-05-17
BS ISO 8637-1. Extracorporeal systems for blood purification - Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-16
- 实施
- 2023-05-16
BS ISO 5910. Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-10
- 实施
- 2023-05-10
This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for coating of orthopedic implants. This specification covers powder requirements only and does not address coating properties. Materials may be manufactured by rotating electrode process, inert gas atomization, or other methods that meet the powder requirements of this specification. The powder shall conform to chemical composition, sieve analysis, and cleanliness requirements of this specification.
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
This document established the currently recognized approaches and special considerations needed when evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, in whole or in part, from them. This document describes how the evaluation of these metals can differ from those utilized for permanent non-absorbable implantable implants (or subcomponents), in that absorbable metal implants (or subcomponents) are — by design — intended to be absorbed in their entirety by the host. This document provides guidance regarding the materials considerations, in vitro degradation/fatigue characterization, and biological evaluation of medical implants made of absorbable metals. The provided content is intended to deliver added clarity to the evaluation of these materials and implants to increase awareness of critical factors and reduce potential for generation of erroneous or misleading test results. While this document and the herein described referenced standards contain many suggested alterations or modifications to currently practiced procedures or specifications, the provided content is intended to complement, and not replace, current conventions regarding the assessment of implantable implants. This document covers the evaluation of absorbable metal specific attributes in general and is not intended to cover application or implant specific considerations. Thus, it is important to consult relevant implant and/or application specific standards. This document does not apply to non-absorbable or non-metallic components (e.g. polymeric coatings, pharmaceuticals, non-absorbable metals) used in conjunction with absorbable metal implants.
Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
Scope is not provided for this standard
Standard Guide for Total Knee Replacement Loading Profiles
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
This specification covers the minimum safety and performance standards that a manufacturer should meet with regards to the design, manufacture, testing, labeling, and documentation of cranial traction tongs and halo external spinal immobilization devices intended for use on humans for therapeutic purposes. It is, however, not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations for such. Requirements to which the devices shall be tested on and conform accordingly to are magnetic resonance imaging (MRI) compatibility, mechanical integrity, design performance, induced current flow, and current induced heating.
Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.
Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
Scope is not provided for this standard
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTE There is guidance or rationale for this list item contained in A.2.
Anaesthetic and respiratory equipment — Voice prostheses
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
Scope is not provided for this standard
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
Scope is not provided for this standard
Standard Test Method for Burst Strength of Surgical Sealants
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
Scope is not provided for this standard
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
These specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test methods establish (1) common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components, and (2) performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components and to describe or specify specific designs for the individual components. For these specifications and test methods may not be appropriate for all types of spinal surgical fixation systems, the appropriateness of these specifications in view of the particular implant system and its potential application shall be considered. The test methods include static and fatigue bending strength tests. Requirements for marking and packaging are specified as well.
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).
Biological evaluation of absorbable medical devices — Part 1: General requirements
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
Scope is not provided for this standard
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- ICS
- 11.040.40
- CCS
- 发布
- 2023-05-03
- 实施
