ISO 10993-1 Materials
ISO 10993-1 is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices to ensure their biocompatibility and safety. ISO 10993-1 focuses on the evaluation and testing of materials used in medical devices to determine their potential biological impact. Compliance with ISO 10993-1 is essential for medical device manufacturers to ensure their products are safe for human use. This guide covers the features, common applications, and the pros and cons of ISO 10993-1 compliant materials.
ISO 10993-1 platinum cured silicone, CanRez® FFKM and Kalrez® O-rings, gasket rapid manufacturing, & custom molded parts are available now!
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Features of ISO 10993-1
ISO 10993-1 outlines several key features related to the biological evaluation of medical device materials:
- Biocompatibility Testing: ISO 10993-1 requires that materials used in medical devices undergo biocompatibility testing to evaluate their interaction with human tissues and fluids. Testing covers aspects like cytotoxicity, sensitization, irritation, and systemic toxicity.
- Risk-Based Approach: The standard encourages manufacturers to take a risk-based approach when evaluating materials. Devices are categorized based on the type and duration of contact with the body, with higher-risk devices requiring more stringent testing.
- Comprehensive Evaluation: ISO 10993-1 calls for a thorough biological evaluation of materials, considering factors such as the potential for material degradation, leaching of harmful substances, and long-term effects of exposure to the body.
- Alignment with Regulatory Standards: The standard aligns with various global regulatory requirements, including FDA and EU Medical Device Regulations, ensuring international compliance and facilitating market access.
- Lifecycle Consideration: ISO 10993-1 requires manufacturers to evaluate biocompatibility throughout the lifecycle of the device, from material selection to post-market surveillance.
Common Applications of ISO 10993-1
ISO 10993-1 is widely applied in the medical device industry to ensure materials are safe for use in devices that come into contact with the human body. Common applications include:
- Implantable Devices: ISO 10993-1 is critical for evaluating materials used in implantable devices such as pacemakers, stents, artificial joints, and heart valves. These devices require rigorous testing due to their prolonged contact with body tissues.
- Surgical Instruments: Medical devices that come into contact with skin, blood, or other tissues during surgery, such as scalpels, forceps, and sutures, must comply with ISO 10993-1 to ensure they do not cause adverse reactions.
- Catheters and Tubing: Devices like catheters and tubing that come into direct contact with blood or other body fluids must be evaluated for biocompatibility under ISO 10993-1.
- Drug Delivery Systems: ISO 10993-1 applies to drug delivery systems such as infusion pumps and inhalers, which may expose patients to materials over extended periods.
- Wound Care Products: Materials used in wound dressings, bandages, and other products that are applied to broken or irritated skin require evaluation under ISO 10993-1 to ensure they are safe for use.
Please consult a Canyon Components Engineer about your specific application and we will use our decades of experience to formulate a solution that fits your need.
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ISO 10993-1 Elastomers
Medical and Pharmaceutical Materials
Discover Medical & Pharmaceutical Materials: designed for safety, compliance, and performance in medical devices, pharmaceutical manufacturing, and drug delivery.
Specialty Compliances
Canyon have materials available for O-rings, gaskets, & custom parts with compliances ranging from ISO 10993-1 and USP Class VI <87> & <88> for medical applications, to FDA CFR 21.177.2600 grades A through F for different food types, to the various drinking water specifications like KTW and NSF. Whether it's metal, rubber, or plastic, Canyon can meet your needs!
Custom Parts
Here at Canyon Components, we make sure to offer our customers any manufacturing technique they desire. Whether your ISO 10993-1 O-rings, gaskets, & custom molded parts be rubber, plastic, or metal, rest assured that Canyon Components can make it!
CanRez™ FFKM Perfluoroelastomer
Extreme temperatures & chemicals require extreme solutions! ISO 10993-1 CanRez™ FFKM materials offer extreme reliability where you need it most! Thousands of sizes in stock now!
Kalrez® FFKM Perfluoroelastomer
Canyon Components offers ISO 10993-1 Kalrez® Perfluoroelastomer (FFKM) O-rings, gaskets, & custom molded parts at competitive prices and with great lead-times.
ISO 10993-1 Parker® O-rings, Parofluor parts, parker FKM Viton
Canyon Components offers ISO 10993-1 Parker Hannifin® O-rings, Gaskets, ISO 10993-1 Perfluoroelastomer (FFKM) parts, & custom molded parts at competitive prices and with great lead-times.
FKM (Viton®, Fluorocarbon)
ISO 10993-1 FKM compounds, O-rings, gaskets, & custom molded parts exhibit excellent mechanical attributes as well as excellent resistance to high temperatures, mineral oil, ozone, fuels, hydraulic fluids, and many other solvents and chemicals.
Aflas® (TFE/P)
ISO 10993-1 TFE/P (Aflas) compounds, O-rings, gaskets, & custom molded parts gives high resistance to steam, hot water, atmospheric wear, and many chemicals. TFE/P compounds provide superior performance in water, steam and virtually all caustic chemicals.
Fluorosilicone (FVMQ)
The mechanical and physical properties of ISO 10993-1 Fluorosilicone O-rings, gaskets, & custom molded parts are very similar to silicone. Fluorosilicone O-rings, gaskets, & custom molded parts offer improved flexibility and strength, better resistance to fuels and mineral oil, but reduced hot air resistance.
Silicone (VMQ, PVMQ)
ISO 10993-1 Silicone seals, O-rings, gaskets, & custom molded parts are excellent for extreme temperatures in static applications. Canyon Components carries a range of silicone materials, and we are happy to custom tailor a seal to meet your application requirements!
EPDM (Ethylene Propylene)
ISO 10993-1 EPDM materials, O-rings, gaskets, & custom molded parts can operate over a wide temperature range, and are compatible with glycol fluids that cause problems for most typical elastomeric seals.
NBR (Nitrile, Buna-N)
ISO 10993-1 Nitrile O-rings, gaskets, & custom molded parts are very oil-resistant, have strong mechanical properties, are resistant to wear, and are relatively inexpensive. These properties make Nitrile the most commonly used general purpose O-ring, gasket, & custom molded part material.
HNBR (Hydrogenated Nitrile)
ISO 10993-1 Hydrogenated Nitrile O-rings, gaskets, & custom molded parts offer higher strength and reduced degradation at high temperatures compared to conventional Nitrile materials. These properties make HNBR materials popular in the oil and gas industry, as well as many applications in the chemical industry.
XNBR (Carboxylated Nitrile)
ISO 10993-1 XNBR O-rings, gaskets, & custom molded parts are similar to Nitrile, but the backbone has been chemically modified with a Carboxylic Acid group. The resulting elastomer is a Nitrile rubber with outstanding abrasion and chemical resistance, superior to that of traditional Nitrile.
Neoprene (CR)
Chloroprene was the first synthetic rubber, and was developed commercially under the name Neoprene®. ISO 10993-1 Chloroprene rubbers, O-rings, gaskets, & custom molded parts contain Chlorine in the polymer to reduce the reactivity to many oxidizing agents, as well as to oil and flame.
Polyurethane (PU, AU)
ISO 10993-1 Polyurethane O-rings, gaskets, & custom molded parts generally have two or three times greater tensile strength and wear resistance than Nitrile and comparable polymers. Polyurethane also provides excellent permeation resistance when compared to most rubbers.
PTFE Encapsulated
ISO 10993-1 FEP and PFA encapsulated O-rings consist of an elastomeric core and a seamlessly closed casing of modified PTFE. The elastomer core of encapsulated O-rings is typically made of FKM (Viton) or VMQ (silicone) and guarantees a uniform pre-tensioning at the sealing point.
Spring Energized Seal (SES)
The harshest environments require specialized solutions. Often times, a Canyon Components ISO 10993-1 Spring Energized Seal (SES) will be needed. SES are typically formatted in a multi-piece assembly consisting of a polymeric sealing component that is wrapped around a spring energizer.
ISO 10993-1 Plastics
ISO 10993-1 Materials Pros & Cons
ISO 10993-1 is a crucial standard for ensuring the biocompatibility and safety of materials used in medical devices. With features like comprehensive biological evaluation, risk-based assessment, and alignment with global regulatory standards, ISO 10993-1 helps manufacturers ensure their products are safe for use in healthcare settings. While the cost and complexity of compliance may pose challenges, the benefits of patient safety, regulatory approval, and global market access make ISO 10993-1 compliance a critical aspect of medical device development. Understanding the features, applications, and potential drawbacks of ISO 10993-1 will help you navigate the compliance process and ensure the success of your medical device products.
Canyon Components strives to meet all customer service requests. Feel free to contact Canyon Components engineering and let our knowledgeable staff help you design the perfect part for your needs.
Pros of ISO 10993-1
ISO 10993-1 compliance offers numerous advantages for medical device manufacturers and patients:
- Ensures Patient Safety: The biocompatibility testing required by ISO 10993-1 helps identify and mitigate potential risks associated with materials used in medical devices, ensuring patient safety and reducing the likelihood of adverse reactions.
- Regulatory Compliance: ISO 10993-1 is recognized by regulatory agencies worldwide, including the FDA and European regulators. Compliance with this standard helps manufacturers meet regulatory requirements, speeding up product approvals and market access.
- Risk Management: By requiring a risk-based approach to material evaluation, ISO 10993-1 helps manufacturers proactively identify and address potential risks throughout the lifecycle of the device, reducing the likelihood of product recalls or failures.
- Comprehensive Testing: The standard provides a thorough framework for evaluating biological risks, ensuring that all aspects of material safety, including short-term and long-term effects, are considered.
- Global Market Access: Compliance with ISO 10993-1 facilitates global market access for medical device manufacturers, as the standard is recognized and accepted by regulatory bodies around the world.
Cons of ISO 10993-1
While ISO 10993-1 compliance is crucial for ensuring the safety of medical devices, there are some challenges associated with it:
- Costly Testing: The biocompatibility testing required by ISO 10993-1 can be expensive, especially for devices that require extensive testing due to prolonged contact with the body.
- Time-Consuming Process: The evaluation and testing process under ISO 10993-1 can be time-consuming, potentially delaying product development and market entry.
- Complexity of Compliance: Meeting ISO 10993-1 requirements can be complex, particularly for manufacturers developing new materials or devices. Ensuring compliance often requires collaboration with testing laboratories and regulatory experts.
- Material Limitations: Some materials that may offer excellent performance in other areas, such as mechanical strength or chemical resistance, may fail biocompatibility testing, limiting their use in medical devices.
Relevant Compliances
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