When you’re developing medical parts that may touch skin or be used in patient-care environments, one question comes up early and often: Is the silicone material suitable for ISO 10993 biocompatibility expectations? For many OEMs, this is not just a technical detail—it directly affects supplier approval, project timelines, and customer confidence. That’s why more teams start their material search with a clear keyword focus: ISO 10993 medical grade liquid silicone rubber (LSR).
GUANGZHOU RUIHE NEW MATERIAL TECHNOLOGY CO.,LTD supplies medical-grade LSR solutions designed for medical components where stable performance and reliable documentation matter. Instead of describing materials with vague phrases like “high quality” or “excellent performance,” we recommend selecting grades based on measurable parameters that engineers can use in drawings, IQC standards, and validation plans. This approach helps reduce repeated material checks, shortens internal decision cycles, and improves consistency when moving from samples to mass production.
What medical buyers and engineers care about (simple and practical)
Most medical projects don’t fail because a material is “not strong enough.” They fail because something becomes unpredictable during production or long-term use. In silicone selection, the most common concerns are:
Biocompatibility risk (ISO 10993): the material must fit biocompatibility requirements and support smooth approval communication.
Tearing during assembly: thin edges or small features can tear if tear strength is too low.
Sealing force loss over time: if the material takes a set (permanent deformation), seals may leak or fit changes.
Appearance change: transparent or light-colored parts can yellow or look aged after time.
Manufacturing stability: viscosity and hardness consistency affect molding repeatability and defect rate.
Key LSR Specification Snapshot (Typical Values / Ranges)
Below is a compact specification view you can reference when comparing grades. Exact values depend on the selected grade, but these ranges help teams shortlist quickly and communicate requirements clearly.
Parameter Typical Range / Value Why it matters
Appearance Transparent / Translucent / Milky Choose based on cosmetic/visual needs
| Parameter | Typical Range / Value | Why it matters |
|---|---|---|
| Appearance | Transparent / Translucent / Milky | Choose based on cosmetic/visual needs |
| Hardness | Shore A 10–71 | From soft-touch to firm functional parts |
| Viscosity | 600–3000 Pa·s | Influences filling, flow, and process stability |
| Density | 0.99–1.14 g/cm³ | Helps keep part weight and consistency stable |
| Tensile Strength | 1.5–12 MPa | Supports mechanical integrity in service |
| Elongation at Break | 100–850% | Helps parts flex without cracking |
| Tear Strength | 5–40 kN/m | Reduces tearing during demolding/assembly |
| Tensile Set | 0.8–≤3.2% | Lower = better recovery for sealing performance |
| Linear Shrinkage | ≈2.1–2.7% | Supports dimensional stability and fit control |
If your team wants a quick selection method, try this 3-step filter:
Start with hardness (Shore A):
Softer grades are often used for comfort, soft-touch, or flexible sealing.
Higher hardness grades are used when the part needs more shape stability.
Decide what failure risk is most costly:
If you worry about tearing, prioritize higher tear strength and adequate elongation.
If you worry about leakage or fit change, focus on lower tensile set and stable shrinkage.
Confirm appearance requirement:
For clear parts, you’ll care more about long-term appearance stability and resistance to yellowing/aging.
This is a simple but effective way to avoid “trial-and-error selection,” reduce wasted sampling rounds, and align engineering + procurement on the same decision language.
Why ISO 10993 positioning matters for medical projects
Using the phrase ISO 10993 medical grade liquid silicone rubber (LSR) in your documentation is helpful because it matches how many customers, quality teams, and product managers communicate internally. It also makes your project’s material strategy easier to explain and defend—especially when multiple stakeholders are involved. When your material supplier can support selection with clear mechanical ranges and stable processing behavior, you reduce the chance of late-stage changes that can delay tooling decisions or validation schedules.
If you share your target hardness, part type (seal, cover, mask component, accessory), and whether the part needs to be transparent, we can recommend the most suitable medical-grade LSR options for evaluation.
Contact
Tel: 86 13421773611
Whatsapp/Wechat: 86 13421773611
Email: wendy@ruihesilica.com
