沙格实验室（上海沙格医疗科技有限公司）
上海浦东与安徽合肥各设一座独立实验室，两地均持有 IAS、CNAS 与 CMA 三项资质；已通过 ISO/IEC 17025:2017 实验室体系认可。
资质与认可
| 资质 | 证书编号 | 范围 | 有效期至 | 核验 |
|---|---|---|---|---|
| CNAS 实验室认可 | — | 医疗器械检测（认可范围以 CNAS 官方名录为准） | 以官方名录为准 | 官方查询 |
| CMA 资质认定 | — | 检验检测机构资质认定（范围以全国认证认可信息平台为准） | 以官方名录为准 | 官方查询 |
| 美国 IAS 认可 | — | 美国 IAS 实验室认可 | 以官方名录为准 | 官方查询 |
| ILAC-MRA 国际互认 | — | ILAC-MRA 国际互认（经 CNAS 签署方） | 以官方名录为准 | 官方查询 |
本站未登记上述资质的证书编号。请通过每行右侧的官方查询入口按机构名称核验，认可状态与范围以官方名录为准。
可测标准
以下清单来自该机构公开发布的检测能力说明，不是认可附表。实验室可以承接认可范围之外的检测并出具非认可报告，两者可能有差异；认可范围请以官方名录为准。
| 标准 | 名称 |
|---|---|
| 专用 EN 12182 | 标题待补 |
| 专用 EN 12183 | Manual wheelchairs - Requirements and test methods |
| 专用 EN 12184 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| 专用 EN 13795 | 标题待补 |
| 专用 EN 14683 | Medical face masks - Requirements and test methods |
| 专用 EN 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 引用 GB 2626 | 标题待补 |
| 引用 GB 4793-1 | 标题待补 |
| 专用 GB 7543 | 一次性使用灭菌橡胶外科手套 |
| 专用 GB 8368 | 一次性使用输液器 重力输液式 |
| 专用 GB 9706-1 | 医用电气设备 第1部分：基本安全和基本性能的通用要求 |
| 专用 GB 10213 | 标题待补 |
| 专用 GB 12996 | 标题待补 |
| 专用 GB 15810 | 一次性使用无菌注射器 |
| 专用 GB 19082 | 医用一次性防护服 |
| 专用 GB 19083 | 医用防护口罩技术要求 |
| 引用 GB/T 4857 | 标题待补 |
| 专用 GB/T 12996 | 电动轮椅车 |
| 专用 GB/T 14233 | 标题待补 |
| 专用 GB/T 16886 | 标题待补 |
| 专用 GB/T 16886-7 | 医疗器械生物学评价 第7部分:环氧乙烷灭菌残留量 |
| 专用 GB/T 18029 | 轮椅车 座（靠）垫阻燃性的要求和测试方法 |
| 引用 GB/T 18268 | 标题待补 |
| 专用 GB/T 19633 | 最终灭菌医疗器械的包装 |
| 专用 IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
| 引用 IEC 61000 | 标题待补 |
| 引用 IEC 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section |
| 专用 ISO 7176 | Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
| 专用 ISO 7176-1 | Wheelchairs - Part 1: Determination of static stability |
| 专用 ISO 7176-2 | Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
| 专用 ISO 7176-3 | Wheelchairs - Part 3: Determination of effectiveness of brakes |
| 专用 ISO 7176-4 | Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
| 专用 ISO 7176-5 | Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
| 专用 ISO 7176-6 | Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs |
| 专用 ISO 7176-8 | Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
| 专用 ISO 7176-9 | Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
| 专用 ISO 7176-10 | Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
| 专用 ISO 7176-11 | Wheelchairs - Part 11: Test dummies |
| 专用 ISO 7176-14 | Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
| 专用 ISO 7176-15 | Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
| 专用 ISO 7176-16 | 标题待补 |
| 专用 ISO 7176-21 | Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| 专用 ISO 7176-22 | Wheelchairs - Part 22: Set-up procedures |
| 专用 ISO 7176-25 | Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods |
| 专用 ISO 7176-31 | Wheelchairs -- Part 31: Lithium-ion battery systems and chargers for powered wheelchairs--Requirements and test methods |
| 专用 ISO 7886 | 标题待补 |
| 专用 ISO 9626 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| 专用 ISO 10993 | 标题待补 |
| 专用 ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| 专用 ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] |
| 专用 ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
| 专用 ISO 10993-18 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]. |
| 专用 ISO 11135 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] |
| 专用 ISO 11137 | 标题待补 |
| 专用 ISO 11199 | 标题待补 |
| 专用 ISO 11199-1 | Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames |
| 专用 ISO 11199-2 | Assistive products for walking manipulated by both arms - Requirements and test methods Part 2: Rollators [Including Amendment 1 (2024)]. |
| 专用 ISO 11199-3 | 标题待补 |
| 专用 ISO 11334 | 标题待补 |
| 专用 ISO 11334-1 | 标题待补 |
| 专用 ISO 11334-4 | 标题待补 |
| 专用 ISO 11607 | 标题待补 |
| 专用 ISO 13485 | 标题待补 |
| 专用 ISO 16603 | 标题待补 |
| 专用 ISO 16604 | 标题待补 |
| 专用 ISO 17665 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 专用 ISO 18562 | 标题待补 |
| 专用 YY 0285 | 标题待补 |
| 专用 YY 0469 | 医用外科口罩 |
| 专用 YY 0505 | 医用电气设备 第1-2部分：安全通用要求 并列标准：电磁兼容 要求和试验 |
| 专用 YY/T 0127 | 标题待补 |
| 专用 YY/T 0170 | 牙挺 |
| 专用 YY/T 0506 | 标题待补 |
| 专用 YY/T 0681 | 标题待补 |
| 专用 YY/T 0969 | 一次性使用医用口罩 |
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