RWD S31010-01 / S31011-01 / S31012-01 / S31015-01 Sterile Disposable Surgical Blades

Overview

The RWD S31010-01, S31011-01, S31012-01, and S31015-01 sterile disposable surgical blades are precision-engineered cutting instruments designed for single-use applications in human and veterinary surgical procedures. These blades conform to internationally recognized blade numbering standards (ISO 7740-1:2019), where each designation corresponds to a specific geometry, cutting edge profile, and intended clinical use. The S31010-01 features a broad, slightly curved cutting edge suitable for general incisions and soft tissue dissection; the S31011-01 incorporates a narrow, pointed tip optimized for precise puncture and fine incision tasks; the S31012-01 delivers an acute, triangular geometry ideal for delicate ophthalmic or neurosurgical interventions; and the S31015-01 offers a reinforced, elongated convex edge for controlled, deep-tissue incisions with minimal lateral force. All variants are manufactured from high-carbon stainless steel (AISI 420 or equivalent), heat-treated to achieve Rockwell hardness of 55–58 HRC, ensuring consistent edge retention and resistance to micro-chipping during routine handling and use.

Key Features

• Manufactured under ISO 13485:2016-certified quality management systems, with full traceability per batch and lot number
• Sterilized via ethylene oxide (EO) gas sterilization validated to ISO 11135, with residual EO levels below 4.0 µg/g as verified by GC-MS testing
• Individually sealed in peel-open blister packaging compliant with ISO 11607-1:2019 for sterile barrier integrity
• Blade-to-handle compatibility aligned with the international #3 and #4 scalpel handle interface standard (ISO 7740-2)
• Surface finish polished to Ra ≤ 0.2 µm to minimize tissue drag and reduce adhesion of biological debris
• Non-pyrogenic, non-cytotoxic, and skin-sensitization tested per ISO 10993-5 and ISO 10993-10

Sample Compatibility & Compliance

These surgical blades are intended for use with standard reusable or disposable scalpel handles conforming to ISO 7740-2. They are compatible with all common soft and fibrous biological tissues encountered in general surgery, dermatology, plastic surgery, and experimental animal procedures. Each production lot undergoes 100% visual inspection under 10× magnification for edge continuity, burr absence, and dimensional conformity. Documentation includes Certificate of Conformance (CoC), Certificate of Sterility, and Material Safety Data Summary (MSDS/SDS). The product meets essential requirements of the EU Medical Device Regulation (MDR 2017/745) Class I (non-sterile) / Class Ir (sterile) classification, and is registered with China NMPA (National Medical Products Administration) under registration number valid for Class I medical devices.

Software & Data Management

As a passive, non-electronic, non-connected medical device, these surgical blades do not incorporate embedded software, firmware, or data transmission capabilities. However, RWD provides digital documentation support through its Quality Management System (QMS), enabling customers to access electronic Certificates of Conformance, sterilization validation reports, and batch-specific test records via secure customer portal upon request. All documentation adheres to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) to support GLP, GCP, and GMP-regulated research environments. Traceability data—including raw material lot numbers, forging date, heat treatment parameters, and EO sterilization cycle logs—is retained for minimum 10 years post-manufacture.

Applications

• Human surgical procedures requiring standardized, predictable blade performance (e.g., skin incisions, fascial entry, vascular exposure)
• Veterinary clinical and surgical training programs utilizing cadaveric or live-animal models
• Preclinical research laboratories conducting histopathological sample preparation, organ dissection, or implant site creation
• Medical device evaluation studies where blade consistency directly impacts wound morphology assessment
• Quality control testing of scalpel handle ergonomics and blade-holding torque stability

FAQ

Are these blades compatible with non-RWD scalpel handles?
Yes. All models comply with ISO 7740-2 mechanical interface specifications and are fully interoperable with #3 and #4 handle types from major global manufacturers including Swann-Morton, Feather, and Bard-Parker.

What is the shelf life of unopened blister packs?
The validated shelf life is 5 years from the date of sterilization when stored at ambient temperature (15–30°C), relative humidity ≤ 75%, and protected from direct sunlight and physical compression.

Can these blades be resterilized for reuse?
No. These are designated as single-use, disposable devices per ISO 15223-1 labeling requirements and MDR 2017/745 Annex I General Safety and Performance Requirements. Reprocessing is neither validated nor recommended.

Is technical support available for bulk procurement or custom packaging?
Yes. RWD supports OEM/private label arrangements, custom packaging configurations (e.g., mixed-blade kits, barcoded unit-of-use trays), and regulatory dossier assistance for international market registration.