SUNGO Lab (Shanghai SUNGO Medical Technology Co., Ltd.)
Accreditations
| Scheme | Certificate no. | Scope | Valid to | Verify |
|---|---|---|---|---|
| CNAS accreditation | — | 医疗器械检测（认可范围以 CNAS 官方名录为准） | see official register | official register |
| CMA (China Inspection Body and Laboratory Mandatory Approval) | — | 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） | see official register | official register |
| IAS accreditation (USA) | — | 美国 IAS 实验室认可 | see official register | official register |
| ILAC-MRA | — | ILAC-MRA 国际互认（经 CNAS 签署方） | see official register | official register |
Certificate numbers are not recorded here. Please verify by organisation name through the official register linked in each row; the official register prevails.
Standards covered
The list below is taken from the laboratory's own published description of its testing capability, not from its accreditation schedule. A laboratory may perform tests outside its accredited scope; refer to the official register for the accredited scope.
| Standard | Title |
|---|---|
| device EN 12182 | title pending |
| device EN 12183 | Manual wheelchairs - Requirements and test methods |
| device EN 12184 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| device EN 13795 | title pending |
| device EN 14683 | Medical face masks - Requirements and test methods |
| device EN 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ref GB 2626 | title pending |
| ref GB 4793-1 | title pending |
| device GB 7543 | 一次性使用灭菌橡胶外科手套 |
| device GB 8368 | 一次性使用输液器 重力输液式 |
| device 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 |
| device GB 10213 | title pending |
| device GB 12996 | title pending |
| device GB 15810 | 一次性使用无菌注射器 |
| device GB 19082 | 医用一次性防护服 |
| device GB 19083 | 医用防护口罩技术要求 |
| ref GB/T 4857 | title pending |
| device GB/T 12996 | 电动轮椅车 |
| device GB/T 14233 | title pending |
| device GB/T 16886 | title pending |
| device 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 |
| device GB/T 18029 | 轮椅车 座（靠）垫阻燃性的要求和测试方法 |
| ref GB/T 18268 | title pending |
| device GB/T 19633 | 最终灭菌医疗器械的包装 |
| device 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. |
| ref IEC 61000 | title pending |
| ref 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 |
| device ISO 7176 | Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
| device ISO 7176-1 | Wheelchairs - Part 1: Determination of static stability |
| device ISO 7176-2 | Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
| device ISO 7176-3 | Wheelchairs - Part 3: Determination of effectiveness of brakes |
| device ISO 7176-4 | Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
| device ISO 7176-5 | Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
| device ISO 7176-6 | Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs |
| device ISO 7176-8 | Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
| device ISO 7176-9 | Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
| device ISO 7176-10 | Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
| device ISO 7176-11 | Wheelchairs - Part 11: Test dummies |
| device ISO 7176-14 | Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
| device ISO 7176-15 | Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
| device ISO 7176-16 | title pending |
| device ISO 7176-21 | Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| device ISO 7176-22 | Wheelchairs - Part 22: Set-up procedures |
| device ISO 7176-25 | Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods |
| device ISO 7176-31 | Wheelchairs -- Part 31: Lithium-ion battery systems and chargers for powered wheelchairs--Requirements and test methods |
| device ISO 7886 | title pending |
| device ISO 9626 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| device ISO 10993 | title pending |
| device ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| device 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)] |
| device ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
| device 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)]. |
| device 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)] |
| device ISO 11137 | title pending |
| device ISO 11199 | title pending |
| device ISO 11199-1 | Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames |
| device ISO 11199-2 | Assistive products for walking manipulated by both arms - Requirements and test methods Part 2: Rollators [Including Amendment 1 (2024)]. |
| device ISO 11199-3 | title pending |
| device ISO 11334 | title pending |
| device ISO 11334-1 | title pending |
| device ISO 11334-4 | title pending |
| device ISO 11607 | title pending |
| device ISO 13485 | title pending |
| device ISO 16603 | title pending |
| device ISO 16604 | title pending |
| device ISO 17665 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| device ISO 18562 | title pending |
| device YY 0285 | title pending |
| device YY 0469 | 医用外科口罩 |
| device 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 |
| device YY/T 0127 | title pending |
| device YY/T 0170 | 牙挺 |
| device YY/T 0506 | title pending |
| device YY/T 0681 | title pending |
| device YY/T 0969 | 一次性使用医用口罩 |
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