Isocertificate assessed and approved that the firm meets the requirements for the designated standard.
Scope
Design and Development, Production, Sales, and Distribution of Sterile and Non-Sterile Medical
Surgical Products and Services such as Surgical Suture Products, Endoscopy Instruments, and
Accessories, Surgical Staple and Clip Products, Biofragmentable Anastomosis Rings, Arthroscopy
Implants, Instruments and Accessories, Manual Surgical Instruments with and without Cautery,
Implantable Drug Delivery Systems and Accessories, Hemostatic Materials, Implantable Wound
Dressing Materials, EO Sterilization Services, Biopsy Instrumentation, and Accessories,
Suction/ Irrigation Devices, Ultrasonic Surgical Devices and Accessories, Adhesion Barrier, and
Sealant Systems, Polymer Kits, Sprayer Kits, Flow Sources, Applicators, Powered Stapling Systems,
Sterilization Trays
