OIL for surgical instrument maintenance, bottle, 50ml

STD SSCOOILS5--

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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.
V9007 - Sterile instrument lubricants
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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OIL for instruments

Definition

A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument.

Specifications

Technical specifications

  • Synthetic oil which is vapour permeable and heat resistant up to 260°C
  • The oil is odourless, transparent, biocompatible, non-toxic and free of silicone.
  • It does not cause staining and crusting on the surfaces of the instruments.
  • It is validated for steam (autoclave) sterilisation
  • Content: bottle of 50 ml or 100 - 150 ml (depending availability)

Packaging & Labelling

Unit = plastic bottle with dropper

(Cf Introduction: Packaging and labelling)

Instructions for use

It is recommended to lubricate the movable parts of your instruments once a month.

To be used BEFORE sterilization by steam autoclave:

  • Pre-desinfect, clean and dry the jointed instruments properly
  • Pour a little oil on the joints
  • Wipe off the excess with a clean, non fluffy cloth (the oil film must be as thin as possible)

Do not use industrial oil.

Precautions for Use

Highly flammable substance

MSF requirements

Lubricant used to protect surgical instruments against corrosion, grease mobile parts and prevent mechanical wear.

Bottle is preferred to oil spray with propellant gas of which transport is regulated (UN1950).

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