Surgical Instruments

A constantly growing category of tools which are used during surgery for a variety of purposes, generally to manipulate human tissue. These tools can be intended for a niche, singular purpose or for very broad usage.

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Class IR Instruments

Class IR Instruments

Reusable surgical instruments, all of which must meet specific criteria laid out in EU 2017/745 Medical Device Regulation (MDR).

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Single Use Instruments

Single Use Instruments

Forceps, tweezers, clamps, needle holders, etc. Used to hold or manipulate tissue, blood vessels, or other medical devices.

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Powered Instruments

Powered Instruments

Drills, suction tools, electrosurgical tools, etc. Instruments that may fit into the other categories but require electrical power to operate.

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Robotic surgical devices

Robotic surgical devices

High-tech systems for operating on patients with extreme precision.​

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Surgical Instruments

Surgical instruments are used to cut, hold, or otherwise manipulate human tissue. There are a many categories and subcategories of surgical instrument, developed for either general surgical use or very specific scenarios.

The use of surgical instruments is a practice that is thousands of years old, stretching back into pre-history. In the last few centuries, great strides were made in designing new instruments and improving existing ones to better meet the need of surgeons. This process of continuous improvement and innovation has continued into the present day.

One of the biggest challenges faced by manufacturers of surgical instruments is developing materials that would withstand the corrosive nature of the internal environment of the body, as well as the intensive cleaning practices required to prevent infection. For this reason, the functionality of new devices must be tested after simulating normal use, to make sure they will not break or otherwise complicate surgery.

HTM 01-01: Management and decontamination of surgical instruments used in acute care

HTM 01-01 consists of a list of documents that provide guidance and information on the decontamination and reprocessing of reusabl...

Technical file requirements for Class Ir: Everything you need to know

MDR requires a clear, organized, searchable, and unambiguous technical file presentation

FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5

FDA Validation Requirements for Reusable Medical Devices: guidance on the requirements and criteria for validation data

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