UGPCBのロゴ
製品の概要: A Rigid PCB Engineered for Medical Device Applications
UGPCB Medical Device PCB Board is a 4-layer rigid printed circuit board manufactured in strict compliance with the IPC-6012EM Medical Applications Addendum そして IPC Performance Class 3 要件. This high-reliability 医学 プリント基板 is built on Shengyi S1000H high-performance FR-4 glass-epoxy laminate, with a finished board thickness of 1.6mm and dimensions of 216.3 × 92.6mm. ボード機能 1oz copper foil uniformly distributed across all four layers, paired with an 浸漬シルバー (IAg) 表面仕上げ compliant with IPC-4553A, そしてa green solder mask with white silkscreen legend.
これmedical device PCB is purpose-built for critical healthcare applications including患者モニター, medical imaging systems, infusion pumps, 人工呼吸器, and defibrillators. Under the IPC classification system for printed board reliability, クラス 3 applies to high-performance electronic equipment operating in harsh environments, 必要とする “zero downtime” そして “100% 信頼性”. UGPCB manufactures this4-layer medical PCB to meet these stringent design and performance requirements.
Product Classification and Standard Compliance
Classification by IPC Reliability Level
IPC-6012 defines three reliability classes for rigid printed boards:
- クラス 1: General consumer electronics
- クラス 2: Dedicated service electronics
- クラス 3: High-performance/harsh-environment electronics – medical devices, 航空宇宙, 軍事装備
UGPCB Medical Device PCB Board is rated IPC Performance Class 3 (高性能) and fully complies with IPC-6012EM, the only global industry-consensus standard for medical applications of qualification and performance specifications for rigid printed boards.
Classification by Base Material
- Substrate Category: FR-4.0 high-performance glass-epoxy copper-clad laminate
- Tg Grade: Mid-Tg laminate (Tg ≈ 150–155°C)
- 可燃性評価: UL 94 V-0
Classification by Layer Count
- 4-レイヤーボード: 標準 “信号-グランド-電源-信号” stackup configuration
Classification by Surface Finish
- 浸漬シルバー (IAg) 表面仕上げ, compliant with IPC-4553A
デザインのハイライト: Medical-Grade Standards Drive Precision Engineering
Material Selection – Shengyi S1000H High-Performance Laminate
The base material of a医療用PCB directly determines its thermal reliability, 電気性能, and long-term service life. UGPCB selects Shengyi S1000H laminate, with the following core performance parameters:
| パラメーター | 代表値 | テスト方法 | Engineering Significance |
|---|---|---|---|
| TG (DSC method) | 155℃ | IPC-TM-650 2.4.25 | Lead-free soldering compatible; maintains rigidity at elevated temperatures |
| TG (TMA法) | ~170°C | IPC-TM-650 2.4.24 | Superior Z-axis expansion control |
| TD (5% 減量) | 348℃ | IPC-TM-650 2.4.24.6 | High-temperature soldering resistance; prevents thermal damage |
| CTE (z軸, below Tg) | 37 ppm/°C | IPC-TM-650 2.4.24 | Low Z-axis expansion ensures via reliability |
| CTE (z軸, above Tg) | 250–300 ppm/°C | - | Controls via stress during thermal cycling |
| Dielectric Constant Dk (1GHz) | 4.3–4.6 | - | Stable signal transmission; suitable for digital high-frequency designs |
| Dissipation Factor Df (1GHz) | 0.018–0.022 | - | Moderate signal loss; meets medical device signal integrity requirements |
| 吸水性 | ≤0.15% | - | 低水分吸収; suitable for humid medical environments |
ソース: 盛宜テクノロジー株式会社, 株式会社. S1000H data sheet
S1000H laminate achieves aTd of 348°C, well above the peak temperature of lead-free reflow soldering (approximately 245–260°C), ensuring no material decomposition occurs during soldering. そのT288 heat resistance time ≥5 minutes (measured up to 20 分) means the material withstands 288°C for over 5 minutes without delamination. These thermal properties are critical formedical PCBs operating in demanding environments.
Layer Stackup and Impedance Control
これ4-layer medical device PCB uses a classic stackup configuration:
- 層 1 (トップ): Signal layer
- 層 2 (内層 1): Solid ground plane (GND)
- 層 3 (内層 2): Power plane (力)
- 層 4 (Bottom): Signal layer
これ “信号-グランド-電源-信号” stackup reduces loop inductance by approximately 30% and effectively suppresses electromagnetic interference (エミ), ensuring reliable transmission of sensitive analog signals and high-speed digital signals inmedical electronic devices.
High-Density Routing Design
- 最小穴の直径: 0.1mm – supports HDI-level design
- Minimum Trace Width/Spacing: 0.1mm/0.1mm (approximately 4mil/4mil)
- 銅箔の厚さ: 1oz/1oz/1oz/1oz (approximately 35μm) – equal copper distribution across all four layers
The 0.1mm trace width/spacing represents a high level of precision in プリント基板の製造. Combined with the 0.1mm minimum hole diameter, これ 医療用PCB supports high-density component packages (such as BGA and QFN), meeting the miniaturization and integration trends in medical device design.
Surface Finish – Immersion Silver
これ医療用PCB uses浸漬シルバー (IAg) 表面仕上げ, fully compliant withIPC-4553A Specification for Immersion Silver Plating for Printed Boards. Key advantages of immersion silver include:
- Nickel-free coating: Eliminates magnetic interference and signal issues caused by nickel layers
- High conductivity: Silver offers the best electrical conductivity among all metals
- Uniform thin deposition: Suitable for ultra-fine pitch layouts
- Excellent solderability: Reflow soldering wetting time typically under 2 秒
- Wire bonding capability: Supports gold wire bonding required in medical devices
- RoHS compliant: Lead-free environmentally friendly process
Operating Principle and Signal Integrity
The core operating principle of a medical device PCB can be summarized as: providing mechanical support and electrical interconnection for 電子コンポーネント. For this 4-layer board:
- 信号伝送: Signal traces on the top and bottom layers carry various sensor signals, control signals, and data communication signals. The 0.1mm precision trace width/spacing ensures 高速信号 travel along the shortest possible paths.
- Power Distribution: The inner power layer (層 3) provides stable power distribution to all components on the PCB. The 1oz copper thickness ensures sufficient current-carrying capacity.
- Grounding and Shielding: The solid ground plane (層 2) provides a low-impedance return path for all signals and acts as an electromagnetic shield, preventing electromagnetic interference between different functional modules within the medical device.
- インピーダンス制御: By precisely controlling trace width, 誘電体の厚さ, and dielectric constant (Dk=4.3–4.6 @ 1GHz), the design achieves controlled characteristic impedance (例えば。, 50Ω シングルエンド, 100Ω差動), ensuring signal integrity.
Performance Specifications and Reliability Verification
電気性能
| パラメーター | Value/Standard | ソース |
|---|---|---|
| 誘電率 (1GHz) | 4.3–4.6 | Shengyi S1000H data sheet |
| 損失係数 (1GHz) | 0.018–0.022 | Shengyi S1000H data sheet |
| 表面抵抗率 | ≥10⁹ MΩ | Shengyi S1000H data sheet |
| 体積抵抗率 | ≥10⁸ MΩ·cm | Shengyi S1000H data sheet |
| Dielectric Breakdown Voltage | ≥40 kV/mm | Shengyi S1000H data sheet |
熱性能
| パラメーター | 価値 | ソース |
|---|---|---|
| Glass Transition Temperature Tg (DSC) | 155℃ | Shengyi Technology official data |
| Thermal Decomposition Temperature Td (5% WT損失) | 348℃ | Shengyi Technology official data |
| T260 (no delamination at 260°C) | ≥10 minutes | Shengyi S1000H data sheet |
| T288 (no delamination at 288°C) | ≥5 minutes (20 min measured) | Shengyi S1000H data sheet |
| Z軸CTE (below Tg) | 37 ppm/°C | Shengyi Technology official data |
| Z軸CTE (above Tg) | 250–300 ppm/°C | Shengyi S1000H data sheet |
機械的性能
| パラメーター | 価値 | ソース |
|---|---|---|
| 曲げ強度 | ≥400 MPa | Shengyi S1000H data sheet |
| はく離強度 (copper adhesion) | ≥1.0 N/mm | Shengyi S1000H data sheet |
| ヤングモジュラス | ~20 GPa | Shengyi S1000H data sheet |
| 吸水性 | ≤0.15% | Shengyi S1000H data sheet |
可燃性評価
The base material of thismedical device PCB complies withUL 94 V-0 – meaning that in the vertical burn test, the material self-extinguishes within10 秒 after the flame is removed and does not drip burning particles. This is critical for fire safety inmedical electronic equipment.
製造工程と品質管理
Medical-grade PCBs require strict process control and comprehensive quality inspection. UGPCB’s manufacturing process includes:
Core Manufacturing Steps
- 材料の切断: Cut Shengyi S1000H copper-clad laminate to required dimensions
- Inner Layer Circuitry: Pattern transfer and etching for inner layers (層 2, 層 3)
- Brown Oxide Treatment: Enhances adhesion between inner layer copper and prepreg
- ラミネート加工: Press four layers together under high temperature and pressure
- 掘削: Mechanical drilling of 0.1mm minimum holes
- Electroless Copper Deposition & Panel Plating: Metallization of hole walls for interlayer connections
- Outer Layer Circuitry: Pattern transfer and etching for top and bottom layers
- ソルダーマスクの塗布: Green solder mask printing
- 表面仕上げ: イマージョンシルバー (IAg) プロセス
- Legend Printing: White silkscreen legend
- ルーティング: CNC profile routing
- 電気テスト: Flying probe or fixture testing
- 最終検査: あおい optical inspection + 目視検査
Quality Standards and Certifications
UGPCB Medical Device PCB manufacturing strictly follows these standards:
- IPC-6012EM: Medical Applications Addendum to IPC-6012E
- IPC-A-600: Acceptability of Printed Boards
- IPC-6012クラス 3: クラス 3 performance requirements for rigid printed boards
- IPC-4553A: Immersion silver plating specification
- UL 94 V-0: Flammability rating
- ISO 13485: Medical devices quality management system
Application Scenarios and Operating Environments
Typical Medical Device Applications
これmedical device PCB is widely used in the following medical electronic products:
- Patient Monitors: Multi-parameter monitoring (ECG, SpO₂, NIBP)
- Infusion and Syringe Pumps: Precise control of drug delivery rates
- Ventilators and Anesthesia Machines: Core control boards for life support systems
- 除細動器 (AED): High-reliability emergency medical equipment
- Medical Imaging Systems: Ultrasound diagnostic equipment, portable X-ray machines
- Portable Diagnostic Devices: Glucose meters, handheld pulse oximeters
Operating Environment Requirements
- 動作温度範囲: -40°C〜 +125°C (based on thermal margin of S1000H Tg=155°C)
- Relative Humidity: ≤95% (based on water absorption ≤0.15%)
- Electrical Safety: Compliant with IEC 60601 medical electrical equipment safety standards
- Reliability Requirement: IPCクラス 3 “zero downtime” 標準
Product Feature Summary
| 特徴 | 説明 |
|---|---|
| Medical-Grade Standard | Compliant with IPC-6012EM Medical Addendum + IPCクラス 3 |
| 高性能ラミネート | Shengyi S1000H, Tg=155°C, Td=348°C, UL 94 V-0 |
| 精密な配線 | Minimum trace width/spacing 0.1mm, minimum hole diameter 0.1mm |
| Equal Copper Distribution | 1oz/1oz/1oz/1oz across all four layers |
| Immersion Silver Finish | IPC-4553A compliant, nickel-free, 高い導電性, 優れたはんだ付け性 |
| 低Z軸CTE | CTE (z軸, below Tg) = 37 ppm/°C, ensures via reliability |
| カフェ抵抗 | Excellent resistance to conductive anodic filament formation |
| Lead-Free Compatible | Supports lead-free reflow soldering processes |
Why Choose UGPCB Medical Device PCB?
Authoritative Standard Compliance
UGPCB Medical Device PCB strictly followsIPC-6012EM – the only global industry-consensus standard for medical applications of qualification and performance specifications for rigid printed boards. This standard was developed by the IPC D-33AM Task Group to “eliminate gaps between technical and regulatory requirements”.
Material Science Excellence
TheTd=348°C そしてT288≥5 minutes thermal performance of Shengyi S1000H laminate ensure no material decomposition or delamination occurs during lead-free soldering (peak temperature approximately 245–260°C). TheZ-axis CTE=37 ppm/°C (below Tg) low expansion characteristic effectively reduces via stress in multilayer boards during thermal cycling.
Manufacturing Precision Leadership
The 0.1mm minimum trace width/spacing and 0.1mm minimum hole diameter represent a high level of 精密PCB製造. This precision enables the 医療用PCB to support 高密度相互接続 (HDI) デザイン そして ultra-fine pitch component 組み立て.
Surface Finish Process Excellence
The浸漬シルバー (IAg) surface finish complies withIPC-4553A. The nickel-free coating eliminates magnetic interference, and the uniform thin silver layer ensures優れたはんだ付け性 そしてwire bonding capability – critical for医療機器 that extensively useBGA, QFN, and other fine-pitch packages.
Inquiries and Ordering
UGPCB is committed to providing IPC-6012EM Class 3 準拠 高信頼性 medical device PCBs to medical equipment manufacturers worldwide. Whether you are a medical electronics startup in the product development phase or a large medical device OEM requiring volume production, UGPCB offers a one-stop solution from プリント基板設計 に PCBAアセンブリ.
Contact us today for:
- Free PCB/PCBA engineering consultation and Design for Manufacturability (DFM) assessment
- 医療機器用PCB quotations compliant with IPC Class 3 標準
- Professional material selection recommendations for 高周波ラミネート like Shengyi S1000H
- Technical support for specialty surface finishes including 浸漬シルバー
- Flexible delivery options from small-batch prototyping to high-volume production
📧Sales Inquiries: sales@ugpcb.com
🌐Webサイト: www.ugpcb.com
Data Source Declaration
The technical data and standard information cited in this document are derived from the following authoritative sources:
- IPC-6012 リジッドプリント基板の認定および性能仕様 – Association Connecting Electronics Industries (IPC)
- IPC-6012EM Medical Applications Addendum to IPC-6012E – IPC
- IPC-4553A Specification for Immersion Silver Plating for Printed Boards – IPC
- Shengyi S1000H Laminate Technical Data – Shengyi Technology Co., 株式会社. official data sheet
- UL 94 Tests for Flammability of Plastic Materials for Parts in Devices and Appliances – UL (引き受けの研究所)
- IPC-2221 Generic Standard on Printed Board Design – IPC
- ISO 13485 Medical devices – Quality management systems – International Organization for Standardization (ISO)
