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SCALPEL HANDLE, nº4 standard 01-28-04

https://unicat.msf.org/cat/product/14259
STD ESURSCAL4--

Valid Article

Former Code(s): -X
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
L010103 - Handles for scalpels, reusable
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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Scalpel handle

Definition

A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue.

Specifications

Quality Standards Comment

ISO 7740:1985: Instruments for surgery - Scalpels with detachable blades — Fitting dimensions (confirmed in 2021)

Lays down the dimensions of two models of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers.

Technical specifications

  • Handles of medical scalpels: two types
    • flat handle used in the n°3 and n°4 handles
    • handle like a long writing pen, rounded at the front and flat at the back as in handle n°7
  • Standard scalpel handle for interchangeable blade
  • Length of the handle:
    • ESURSCAL3-- = handle nr 3: 12.5 cm
    • ESURSCAL3L- = handle nr 3L: 21 cm
    • ESURSCAL4-- = handle nr 4: 13.5 cm
    • ESURSCAL4L = handle nr 4: 21 cm
    • ESURSCAL7L = handle nr 7: 16.5 cm
  • The number indicates the characteristic of the distal end, and therefore the choice of blade
  • The number is printed on the handle
  • Material: austenitic steel

Instructions for use

To prevent any risk of injury, use forceps to fit the blade on the handle and to remove it.

Don't forget to order the blades separately (see related articles below). Keep a sufficient stock!

MSF requirements

Handles selected for the blades used in MSF programmes.

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