1. Don’t know how to design and obtain high-quality PCBs? Printed circuit boards, or PCBs, are used in a wide range of applications and industries. You will find them in nearly every sector, including the medical industry, where they are crucial components of advanced medical equipment.
2. Medical-grade PCBs require extremely high precision and accuracy. Designing a medical-grade PCB necessitates an approach that simplifies testing and debugging, as there is no margin for error.
3. Understanding how to design medical-grade PCBs is essential for ensuring you get the best possible performance from your equipment.
4. Medical-grade PCB design standards are governed by regulations set forth in Section 201(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
5. Monitoring equipment and testing machines assist medical manufacturers in adhering to these standards, ensuring their products meet or exceed recognized industry benchmarks. The use of subpar products can pose significant risks.
6. There is no room for error; PCB designers and manufacturers must strictly follow established rules and requirements set by relevant committees.
7. Effective planning and design should focus on facilitating easy assembly and maintenance.
1 Many factors are essential when designing a PCB. Design parameters may vary. However, if you desire easy assembly, disassembly, and maintainability, these factors will be crucial.
2 Service is essential. It helps achieve the required output for medical equipment and machines. Accuracy and precision are vital for the correct diagnosis of test machines. Devices performing complex operations require high-density interconnected medical PCBs. These materials can assist with testing, life support, or monitoring.
3 These PCBs feature a high number of connections in a compact space. Many professionals prefer medical-grade PCBs that combine rigid and flexible elements. Rigid-flex PCBs can be installed in small compartments and are resistant to damage.
4 In medical PCB design standards, we must place significant emphasis on this.
5 Medical electronic equipment design knowledge involves understanding the normal functions and requirements of the target device. Medical PCB requirements may vary by function. Higher thickness medical-grade PCBs are crucial for effective heat dissipation. Adhering to industry standards is a good reference point for accurately analyzing and designing medical-grade PCBs.
6 High-quality manufacturers of medical-grade PCBs adhere to the following rules and regulations:
7 FCC (Federal Communications Commission): Title 47 of the US Code of Federal Regulations.
8 US FDA 21 CFR Part 807: Applicable to manufacturing companies or those selling imported medical devices in the US, including those involved in repackaging or relabeling.
9 IEC 60601-1: Addresses performance and safety parameters for medical electrical equipment.
10 IEC 61010-1: Covers basic requirements for electrical equipment used in measurement and control within medical laboratories.
11 IPC 6011: Discusses overall performance specifications for printed boards.
12 ISO 13485 Medical Devices: Supervises and operates health management systems.
13 ISO 14971 Medical Equipment: Helps manufacturers identify hazards and risks associated with medical equipment.
14 Understanding these regulations can guide you in designing compliant medical PCBs.
15 Discard uncertain components when designing a medical-grade PCB. Thorough knowledge of theory and practical applications is essential. Avoid trial and error, as risks are significant in medical-grade PCBs. Eliminate components you’re unsure about and adhere to the golden rule of electronics—avoid open circuits.
16 This approach will help you avoid unnecessary complications and conserve space.
17 Strict requirements for PCB materials and specifications are critical in the medical industry, where lives are at stake. Medical equipment manufacturing follows stringent protocols. These regulations are mandatory for correct medical-grade PCB service. Fortunately, various PCB manufacturing options are available.
18 You can distinguish PCBs based on several parameters, such as:
19 PCB shape: Medical-grade PCBs usually come in rectangular or circular shapes. Some manufacturers offer custom-shaped options based on customer requirements.
20 Substrate used: Choose the right substrate for your design, as it is crucial in medical-grade PCB design. Classification includes:
21 RoHS compliance.
22 High-speed digital conversion.
23 High-frequency radio frequency.
24 Temperature.
25 Coating and cladding.
26 Industry-standard PCB substrates include Copper Core, RO4003C, and domestic Shengyi PI.
27 High-density interconnect boards (HDI) have more circuit connections than traditional boards, including links throughout the PCB and micro-vias with diameters less than 0.006 inches.
28 There are six types of HDI boards, many of which are medical-grade. Some have vias connecting different surfaces through via-connections. Typically, HDI boards feature more than two layers, connected through vias and passive non-electronic layers, adopting a coreless method.
29 The advantages of HDI in medical-grade PCBs include shape and design efficiency.
30 TG, or glass transition temperature, is a specific temperature range where the base polymer becomes a soft rubber material. Polymers used in circuit boards must not catch fire. Better TG means superior performance, stability, and resistance to heat, humidity, and chemical phenomena in medical-grade PCBs.
31 Quality working environment is essential for determining product standards. Your manufacturer must understand these standards, and PCB designers should be aware of the operating location.
32 Temperature, pressure, humidity, and air quality are crucial parameters affecting your medical device’s output, among others.
33 Finding a reliable manufacturer can be challenging. Emphasize accuracy over reliability, efficiency, or economy, as medical equipment requires precise standards. Manufacturers should comply with medical device regulations.
34 Prepare a questionnaire for potential manufacturers to determine their suitability:
35 How long have you been in the PCB manufacturing business? Longer experience often equates to better performance and adherence to industry standards.
36 Do you produce motherboards for other medical device companies? Experience with medical-grade PCBs is beneficial.
37 Can you avoid using counterfeit components? Companies tracking every component involved tend to be more responsible and provide better products.
38 What quality assurance practices does the manufacturer follow? Ensure they are reliable and capable of delivering high-quality PCBs.
39 What is the manufacturing test method? How will they ensure PCB quality and IPC compliance? Advanced components are particularly crucial for medical-grade PCBs.
40 Has the manufacturer passed ISO 9001 certification? Industry-standard certification helps build trust.
2. Medical-grade PCBs require extremely high precision and accuracy. Designing a medical-grade PCB necessitates an approach that simplifies testing and debugging, as there is no margin for error.
3. Understanding how to design medical-grade PCBs is essential for ensuring you get the best possible performance from your equipment.
4. Medical-grade PCB design standards are governed by regulations set forth in Section 201(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
5. Monitoring equipment and testing machines assist medical manufacturers in adhering to these standards, ensuring their products meet or exceed recognized industry benchmarks. The use of subpar products can pose significant risks.
6. There is no room for error; PCB designers and manufacturers must strictly follow established rules and requirements set by relevant committees.
7. Effective planning and design should focus on facilitating easy assembly and maintenance.
1 Many factors are essential when designing a PCB. Design parameters may vary. However, if you desire easy assembly, disassembly, and maintainability, these factors will be crucial.
2 Service is essential. It helps achieve the required output for medical equipment and machines. Accuracy and precision are vital for the correct diagnosis of test machines. Devices performing complex operations require high-density interconnected medical PCBs. These materials can assist with testing, life support, or monitoring.
3 These PCBs feature a high number of connections in a compact space. Many professionals prefer medical-grade PCBs that combine rigid and flexible elements. Rigid-flex PCBs can be installed in small compartments and are resistant to damage.
4 In medical PCB design standards, we must place significant emphasis on this.
5 Medical electronic equipment design knowledge involves understanding the normal functions and requirements of the target device. Medical PCB requirements may vary by function. Higher thickness medical-grade PCBs are crucial for effective heat dissipation. Adhering to industry standards is a good reference point for accurately analyzing and designing medical-grade PCBs.
6 High-quality manufacturers of medical-grade PCBs adhere to the following rules and regulations:
7 FCC (Federal Communications Commission): Title 47 of the US Code of Federal Regulations.
8 US FDA 21 CFR Part 807: Applicable to manufacturing companies or those selling imported medical devices in the US, including those involved in repackaging or relabeling.
9 IEC 60601-1: Addresses performance and safety parameters for medical electrical equipment.
10 IEC 61010-1: Covers basic requirements for electrical equipment used in measurement and control within medical laboratories.
11 IPC 6011: Discusses overall performance specifications for printed boards.
12 ISO 13485 Medical Devices: Supervises and operates health management systems.
13 ISO 14971 Medical Equipment: Helps manufacturers identify hazards and risks associated with medical equipment.
14 Understanding these regulations can guide you in designing compliant medical PCBs.
15 Discard uncertain components when designing a medical-grade PCB. Thorough knowledge of theory and practical applications is essential. Avoid trial and error, as risks are significant in medical-grade PCBs. Eliminate components you’re unsure about and adhere to the golden rule of electronics—avoid open circuits.
16 This approach will help you avoid unnecessary complications and conserve space.
17 Strict requirements for PCB materials and specifications are critical in the medical industry, where lives are at stake. Medical equipment manufacturing follows stringent protocols. These regulations are mandatory for correct medical-grade PCB service. Fortunately, various PCB manufacturing options are available.
18 You can distinguish PCBs based on several parameters, such as:
19 PCB shape: Medical-grade PCBs usually come in rectangular or circular shapes. Some manufacturers offer custom-shaped options based on customer requirements.
20 Substrate used: Choose the right substrate for your design, as it is crucial in medical-grade PCB design. Classification includes:
21 RoHS compliance.
22 High-speed digital conversion.
23 High-frequency radio frequency.
24 Temperature.
25 Coating and cladding.
26 Industry-standard PCB substrates include Copper Core, RO4003C, and domestic Shengyi PI.
27 High-density interconnect boards (HDI) have more circuit connections than traditional boards, including links throughout the PCB and micro-vias with diameters less than 0.006 inches.
28 There are six types of HDI boards, many of which are medical-grade. Some have vias connecting different surfaces through via-connections. Typically, HDI boards feature more than two layers, connected through vias and passive non-electronic layers, adopting a coreless method.
29 The advantages of HDI in medical-grade PCBs include shape and design efficiency.
30 TG, or glass transition temperature, is a specific temperature range where the base polymer becomes a soft rubber material. Polymers used in circuit boards must not catch fire. Better TG means superior performance, stability, and resistance to heat, humidity, and chemical phenomena in medical-grade PCBs.
31 Quality working environment is essential for determining product standards. Your manufacturer must understand these standards, and PCB designers should be aware of the operating location.
32 Temperature, pressure, humidity, and air quality are crucial parameters affecting your medical device’s output, among others.
33 Finding a reliable manufacturer can be challenging. Emphasize accuracy over reliability, efficiency, or economy, as medical equipment requires precise standards. Manufacturers should comply with medical device regulations.
34 Prepare a questionnaire for potential manufacturers to determine their suitability:
35 How long have you been in the PCB manufacturing business? Longer experience often equates to better performance and adherence to industry standards.
36 Do you produce motherboards for other medical device companies? Experience with medical-grade PCBs is beneficial.
37 Can you avoid using counterfeit components? Companies tracking every component involved tend to be more responsible and provide better products.
38 What quality assurance practices does the manufacturer follow? Ensure they are reliable and capable of delivering high-quality PCBs.
39 What is the manufacturing test method? How will they ensure PCB quality and IPC compliance? Advanced components are particularly crucial for medical-grade PCBs.
40 Has the manufacturer passed ISO 9001 certification? Industry-standard certification helps build trust.
