外科植入物
本类别共 9 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| ISO 5832-1:2016 | Implants for surgery - Metallic materials - Part 1: Wrought stainless steel | Implants for surgery -- Metallic materials -- Wrought stainless steel. | 10, 14 |
| ISO 5832-3:2016 | Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy | Implants for surgery -- Metallic materials -- Wrought titanium 6-aluminium 4-van... | 10, 14 |
| ISO 5840-1:2021 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements | Cardiovascular implants -- Cardiac valve prostheses -- General requirements. | 10, 14, 19 |
| ISO 14708-1:2014 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer | Implants for surgery -- Active implantable medical devices -- General requiremen... | 14, 18, 19, 23 |
| ASTM F2083:2021 | Standard Specification for Knee Replacement Prosthesis | Standard specification for knee replacement prosthesis. | 10, 14 |
| ASTM F2033:2020 | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials | Standard specification for total hip joint prosthesis and hip endoprosthesis bea... | 10, 14 |
| IEC 60601-2-41:2021 | Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis | Surgical luminaires and luminaires for diagnosis. | 14, 14.1 |
| IEC 60601-2-46:2016 | Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables | Operating tables. | 14, 14.1 |
| IEC 60601-2-76:2018 | Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment | Low energy ionized gas haemostasis equipment. | 14, 14.1 |