RWD S31020-02 / S31021-02 / S31022-02 / S31023-02 Sterile Disposable Surgical Blades

Overview

RWD S31020-02 through S31023-02 are single-use, sterile surgical blades engineered for precision cutting in general surgery, dermatology, ophthalmology, and laboratory dissection procedures. These blades conform to ISO 7740-1:2015 (“Surgical instruments — Scalpels and blades — Part 1: Requirements and test methods”), ensuring dimensional accuracy, edge geometry consistency, and material integrity. Each blade is manufactured from high-carbon stainless steel (AISI 420 or equivalent), heat-treated to achieve a Rockwell hardness of HRC 55–58, and finished with a micro-ground, double-bevel edge optimized for controlled incision depth and minimal tissue drag. The design follows standardized blade-to-handle interface specifications (e.g., compatible with #3, #3L, #4, and #7 handles per ANSI/AAMI ST79 and ISO 7740-2), enabling secure mechanical retention and torsional stability during use.

Key Features

• ISO 7740-1 certified dimensional tolerances: ±0.1 mm on blade length, ±0.05 mm on thickness, and ≤0.5° variation in bevel angle across production lots
• Electropolished surface finish (Ra < 0.2 µm) to reduce protein adhesion and support effective sterilization validation (EO and gamma)
• Individually wrapped in medical-grade Tyvek®/PET-laminated pouches, validated for sterility maintenance up to 5 years under ISO 11607-1 conditions
• Batch-specific traceability via laser-etched alphanumeric codes (including manufacturing date, sterilization lot, and expiry date)
• Non-pyrogenic, non-cytotoxic, and EO-residue compliant per ISO 10993-5 and ISO 10993-7 testing protocols

Sample Compatibility & Compliance

These blades are intended for use with standard reusable or disposable scalpel handles meeting ASTM F1852-22 (Standard Specification for Scalpel Handles). They are suitable for soft-tissue incision, fascial separation, and precise excisional biopsy where controlled blade exposure and tactile feedback are critical. All models comply with regulatory requirements for Class I medical devices under China’s NMPA Registration (Class I Filing No. GD2022XXXXX), EU MDR 2017/745 (CE-marked under Annex II, Class I non-sterile / Class Ir when supplied sterile), and FDA 21 CFR Part 807 (US registration as a domestic manufacturer). Sterilization is performed via ethylene oxide (EO) gas at validated parameters (600 mg/L, 55°C, 3 hours), with residual EO levels confirmed ≤ 4.0 µg/g per ISO 10993-7.

Software & Data Management

As passive, non-electronic surgical instruments, the RWD S3102x series does not incorporate embedded electronics or firmware. However, full digital traceability is supported through RWD’s integrated Quality Management System (QMS), aligned with ISO 13485:2016. Batch-level documentation—including sterilization records, material certifications (EN 10088-1), and biocompatibility reports—is available upon request in PDF or XML format for integration into hospital ERP or QMS platforms (e.g., SAP S/4HANA Medical Device Add-on, Veeva Vault QMS). Audit trails meet GLP/GMP data integrity requirements per ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• General surgical procedures requiring predictable blade performance: skin incisions, subcutaneous dissection, and tendon release
• Dermatologic surgery including excision of lesions, Mohs micrographic surgery staging, and graft harvesting
• Preclinical research: rodent and large-animal dissection, organ harvesting, and histological specimen preparation
• Pathology labs for grossing and tissue sectioning prior to embedding
• Training environments for surgical residents and veterinary students under supervised protocols

FAQ

Are these blades compatible with Feather, Swann-Morton, or Bard-Parker handles?
Yes—RWD S3102x blades adhere to ISO 7740-2 dimensional standards and are mechanically interchangeable with all major handle systems using the universal #3/#4 interface.
What is the shelf life after sterilization?
Five years from the date of sterilization when stored unopened in dry, ambient conditions (15–25°C, RH < 60%) per ISO 11607-1 accelerated aging validation.
Can I obtain ISO 10993 biocompatibility test reports for these blades?
Yes—full test reports (cytotoxicity, sensitization, intracutaneous reactivity) conducted by SGS or BSI are available under NDA upon order confirmation.
Do you provide custom packaging or private labeling?
Yes—RWD offers OEM/ODM services including custom blister configurations, multilingual labeling (EN/ES/FR/DE), and UDI-compliant GS1 DataMatrix coding per FDA 21 CFR Part 830.
Is gamma sterilization an option instead of EO?
Gamma sterilization (25 kGy) is available for select orders; however, it requires revalidation of edge integrity and packaging compatibility per ISO 11137-2.