Certifications and standards (medical devices and biocompatible applications)
Certifications and standards (medical devices and biocompatible applications)
Formlabs 质量策略
Formlabs 基于以下质量策略设计和制造用于牙科、听力学和手术规划工具的 3D 打印生物相容性应用光敏树脂：
Formlabs 致力于提供安全、有效的 3D 打印光敏树脂，提供的树脂均符合全部相关法规，始终能满足甚至超出客户预期。公司专注于凭借有效的质量管理体系不断改进生产流程。
牙科器械标准
Formlabs 生物相容性应用树脂依据以下标准开发：
- ISO 7405 《牙科学－牙科医疗器械生物相容性评估》
- ISO 10993-1 《医疗器械生物安全性评估－第 1 部分：风险管理过程中的评估和测试》
- ISO 14971 《医疗器械－医疗器械风险管理的应用》
- ISO 18562-1 《医用呼吸气体通道的生物相容性评估－第 1 部分：风险管理过程中的评估和测试》
| 认证 | Custom Tray Resin | Dental LT Clear Resin V1 | Dental LT Clear Resin V2 | Denture Base Resin | Denture Teeth Resin | IBT Resin | Permanent Crown Resin | Premium Teeth Resin | Surgical Guide Resin | Temporary CB Resin |
|---|---|---|---|---|---|---|---|---|---|---|
| ISO 10993 接触类型：粘膜 接触时间：< 24 小时 | ||||||||||
| ISO 10993-1 皮肤接触 | - | ✔ | ✔ | ✔ | ✔ | - | ✔ | ✔ | ✔ | ✔ |
| ISO 10993-3 无诱变性 | - | ✔ | ✔ | ✔ | ✔ | - | ✔ | ✔ | ✔ | ✔ |
| ISO 10993-5 无诱变性 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| ISO 10993-10 非刺激物或致敏剂 | ✔ | - | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| ISO 10993-11 USP 通则<151> 无热原 | ✔ | - | ✔ | ✔ | - | - | - | - | - | - |
| ISO 10993-11 无急性全身毒性相关证据 | ✔ | - | ✔ | ✔ | ✔ | - | - | ✔ | - | - |
| ISO 13485 《医疗器械－质量管理体系－用于法规的要求》 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| 灭菌相容性 尺寸完整性、机械性能、细胞毒性、颜色 电子束 伽玛 EtO 蒸汽（5 个周期） | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
联系销售，索取书面声明或技术规格文档。有关安全注意事项、操作方法和技术数据，请访问我们的 Formlabs 立体光固化 3D 打印机技术参数页面。有关溶剂兼容性信息，请访问支持文档溶剂兼容性。
医疗器械标准
Formlabs 生物相容性应用材料依据以下标准开发：
- ISO 7405 《牙科学－牙科医疗器械生物相容性评估》
- ISO 10993-1 《医疗器械生物安全性评估－第 1 部分：风险管理过程中的评估和测试》
- ISO 14971 《医疗器械－医疗器械风险管理的应用》
- ISO 18562-1 《医用呼吸气体通道的生物相容性评估－第 1 部分：风险管理过程中的评估和测试》
经过检测，材料还达到了以下生物相容性风险要求（基于产品）：
| Contact Type | Skin | Mucosal Membrane | Bone, Tissue, & Dentin | Pharmaceutical Containers, Drug Delivery & Medical Device Components | Mucosal Membrane | Breathing Gas Pathways | Sterilization Compatibility |
|---|---|---|---|---|---|---|---|
| Contact Duration | > 30 days | < 24 hours | < 24 hours | - | > 30 days | > 30 days | - |
| Applicable ISO Standard | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | USP <151> Pyrogen ISO 10993-5 ISO 10993-10 ISO 10993-11 ISO 10993-23 | USP <88> Class VI | ISO 10993-1 ISO 10993-3 ISO 10993-5 ISO 10993-10 ISO 10993-11 ISO 10993-23 | ISO 18562-2 ISO 18562-3 | |
| BioMed Clear | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | Steam, Gamma, Et0, E-Beam |
| BioMed Durable | ✔ | ✔ | ✔ | ✔ | ✔ | - | Steam, Gamma, Et0, E-Beam |
| BioMed White | ✔ | ✔ | ✔ | ✔ | - | - | Steam, Gamma, Et0, E-Beam |
| BioMed Amber | ✔ | ✔ | ✔ | - | - | - | Steam, Gamma, Et0, E-Beam |
| BioMed Black | ✔ | ✔ | - | ✔ | - | - | Steam, Gamma, Et0, E-Beam |
| BioMed Flex 50A | ✔ | ✔ | - | - | - | - | Test pending |
| BioMed Flex 80A | ✔ | ✔ | - | - | - | - | Disinfection |
| Silicone 40A Resin | ✔ | ✔ | - | - | - | - | - |
| Tough 1500 Resin | ✔ | - | - | - | - | - | Steam, Gamma, Et0, E-Beam |
| PU Rigid 650 Resin | ✔ | - | - | - | - | - | - |
| PU Rigid 1000 Resin | ✔ | - | - | - | - | - | - |
| Nylon 11 Powder | ✔ | ✔ | - | - | - | - | - |
| Nylon 11 CF Powder | ✔ | ✔ | - | - | - | - | - |
| Nylon 12 Powder | ✔ | ✔ | ✔ | - | - | - | Steam, Gamma, Et0, E-Beam |
| Nylon 12 GF Powder | ✔ | ✔ | - | - | - | - | - |
| Nylon 12 Tough Powder | ✔ | ✔ | ✔ | - | - | - | - |
| Nylon 12 White Powder | ✔ | ✔ | ✔ | - | - | - | - |
| TPU 90A Powder | ✔ | ✔ | - | - | - | - | - |
联系销售，索取书面声明或技术规格文档。有关安全注意事项、操作方法和技术数据，请访问我们的 Formlabs 立体光固化 3D 打印机技术参数页面。有关溶剂兼容性信息，请访问支持文档溶剂兼容性。
生物相容性认证 (ISO 10993)
| Resins | Powders |
|---|---|
用户说明书
- 支持文档：
- 用于生物相容性应用的 Formlabs 树脂制造指南、使用说明和应用指南
- Formlabs SDS 库
质量体系标准
Formlabs resins for biocompatible applications
- ISO 13485:2016 (All)
- Formlabs is registered (Registration Number: 3015491441) with the US FDA. Please see the following FDA Link.
- The Manufacturer of Dental LT Clear Resin and Dental SG Resin (VERTEX-DENTAL B.V.) is registered with the US FDA (Registration Number: 8030452) Please see the following FDA Link.
- The Manufacturer of Denture Base Resin and Denture Teeth Resin (DENTCA Inc.) is registered with the US FDA (Registration Number: 3009312537) Please see the following FDA Link.
- The Manufacturer of Temporary CB Resin (BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG) is registered with the US FDA (Registration number: 9611514) Please see the following FDA Link.
- Formlabs has an MDEL (Medical Device Establishment License): Company ID: 23828
- Formlabs Denture Teeth Resin: License No. 104548
- Formlabs Denture Base Resin: License No. 104714
- Dental LT Clear Resin V2: License No. 109327
- Dental LT Comfort Resin: License No. 109714
- Premium Teeth Resin: License No. 110852
- IBT, IBT Flex, Dental SG, Surgical Guide, and Custom Tray Resins: There are no Medical Device Licenses (MDLs) for these Resins. They are Class I devices and do not require or have them.
- Dental LT Clear Resin: License No. 98431
- The Manufacturer of Dental LT Clear Resin and Dental SG Resin (VERTEX-DENTAL B.V.) has an MDEL (Medical Device Establishment License): Company ID: 128421
- Temporary CB Resin: License No. 102710
- The Manufacturer of Temporary CB Resin (BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG) has an MDEL (Medical Device Establishment License): Company ID: 125184
FDA 设备主文档 (MAF)
Formlabs has a Device Master File (MAF) with FDA for BioMed Amber, BioMed Black, BioMed Clear, BioMed Durable, BioMed White, BioMed Flex 50A, and BioMed Flex 80A Resin. Information in the MAF may be referenced in your PMA, 510(k), IDE, or other submissions to FDA. Please contact your sales representative for a letter of authorization.
用于诊断的术前规划模型：
Formlabs 是业界领先的 3D 打印机和材料制造商，其产品可由医疗保健提供商用于支持医疗执业。请查阅法规信息页面，详细了解如何利用 Formlabs 机器生成供诊断使用的术前规划模型。
IQ/OQ/PQ 校准工具和模板
IQ/OQ/PQ 校准工具和模板仅适用于 Form 3B/3B+、Form 3BL、Fuse 1 和 Fuse 1+ 30W 的医疗专业客户。请联系 Formlabs 确认资格并索取这些表格。请访问 Formlabs 支持网站，获取 Formlabs 硬件的维护计划。