ISO 10993 Silicones
ISO 10993 silicones meet the requirements of an international standard for evaluating the biocompatibility of medical grade silicones. ISO 10993 contains more extensive testing requirements than USP Class VI and ensures that medical devices don’t cause adverse biological reactions in the people who use them.
ElastaPro is a Made in USA manufacturer of ISO 10993 silicones. We offer these materials as solid silicone sheets, continuous rolls, and uncured compound. Our medical grade silicones also meet FDA Title 21 CFR 177.2600, USP Class VI, and European Pharmacopoeia requirements. Contact us to request a quote or discuss your medical device or equipment application.
ISO 10993 Silicone Sheet
ElastaPro calendars ISO 10993 silicones into medical silicone sheeting that can be die cut into parts for peristaltic pumps, insulin pumps, and other types of medical devices and equipment. This process creates flexible, durable silicone sheets that can be precisely controlled for thickness, texture, and other properties.
ISO 10993 silicone sheeting is available in:
- Durometers: 10 to 70 Shore A
- Thicknesses: .007” to .500”
- Widths: Up to 60”
- Colors: While typically translucent, various colors are available
These products are Made to Order and supplied in a gloss or matte finish.
The following ElastaPro part numbers have had a ISO 10993 study performed for cytotoxicity, hemolysis, pyrogenicity, sensitization, dermal irritation, and implantantation (90 days)
- ESS10HC
- ESS20HC
- ESS30HC
- ESS40HC
- ESS45HC
- ESS50HC
- ESS55HC
- ESS60HC
- ESS70HC
The results showed no relevant biological effects in the study’s performance.
ISO 10993 Continuous Rolls
ElastaPro can also supply you with ISO 10993 silicone rolls that we can slit-to-width for automated cutting operations.
ISO 10993 Uncured Silicone Compound
In addition to medical grade silicone sheets, ElastaPro offers uncured silicone compound that arrives ready-to-mold. Our materials are supplied rolled-up off the mill or in sheet form with a poly liner.
What is ISO 10993?
ISO 10993 is a standard from the International Standards Organization (ISO) that provides a framework for evaluating a silicone’s suitability for medical uses. More specifically, it covers risk management, material characterization, testing protocols, and device categories. Compliant materials are biologically inert and pass specific tests for cytotoxicity and irritation/sensitization.
Ultimately, ISO 10993 is designed to ensure that medical grade silicones won’t harm patients through toxicity or immune system reactions. It’s testing standards for the biological evaluation of medical devices are more extensive than those of USP Class VI, but testing medical silicones to ISO 10993 is more than most non-implantable applications require.
FAQs for ISO 10993 Silicones
What is ISO 10993 and why is it important for silicone materials?
ISO 10993 is an international standard that evaluates the biocompatibility of materials used in medical devices. It assesses cytotoxicity, sensitization, irritation, systemic toxicity, and other biological responses. Silicone materials that meet ISO 10993 requirements are suitable for applications involving patient contact, fluid handling, and regulated medical environments.
What types of ISO 10993 testing apply to silicone sheet and silicone compounds?
Common ISO 10993 tests for silicone include cytotoxicity (ISO 10993‑5), sensitization and irritation (ISO 10993‑10), systemic toxicity (ISO 10993‑11), and extractables/leachables evaluations. The specific tests required depend on the device’s classification and the duration and type of patient contact.
Are ElastaPro’s ISO 10993 silicones platinum‑cured?
Yes. ElastaPro’s ISO 10993‑compliant silicones are platinum‑cured to minimize extractables, eliminate peroxide by‑products, and support the purity and stability required for medical and bioprocessing applications.
What applications commonly use ISO 10993‑compliant silicone?
ISO 10993 silicones are used in medical device components, pharmaceutical seals and gaskets, fluid‑handling systems, pump diaphragms, bioprocessing equipment, and environments requiring low extractables and consistent mechanical performance.
How do ISO 10993 silicones compare to USP Class VI silicones?
Both standards address biocompatibility, but ISO 10993 provides a broader, modular framework aligned with global medical device regulations. USP Class VI is a more traditional U.S. pharmacological standard. Many medical manufacturers use both to support regulatory submissions and risk assessments.
What temperature range can ISO 10993‑compliant silicone withstand?
ElastaPro’s ISO 10993 silicones typically perform from −80°F to +450°F, with intermittent resistance up to 500°F. This thermal stability supports sterilization methods such as autoclaving, dry heat, and repeated thermal cycling.
Can ISO 10993 silicone be customized for specific medical or bioprocessing requirements?
Yes. ElastaPro can tailor durometer, thickness, width, color, and mechanical properties to meet application‑specific needs. Custom formulations and lot‑traceable production are available for regulated environments.
Does ISO 10993 certification guarantee FDA compliance?
ISO 10993 supports FDA expectations for biocompatibility, but it is not a standalone FDA certification. However, ISO 10993‑tested silicones are commonly used in FDA‑regulated devices, and the standard is widely accepted as part of a device’s biological evaluation plan.
Ask ElastaPro for ISO 10993 Silicones
Do you need ISO 10993 silicones for medical devices or equipment? Contact ElastaPro for specifications grade solid silicone sheets, continuous rolls, and ready-to-mold compounds. Our medical grade elastomers meet ISO 10993 requirements and they also comply with FDA Title 21 CFR 177.2600 regulations and USP Class VI and European Union Pharmacopeia standards.
