GONAD RADIATION SHIELDING APRON, 0.5 mm Pb equivalent, neon

STD EDIMGONS1N-

Valid Article

Former Code(s): -X
Article is intended to be used with children (<12 years) ONLY.
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.
T0304 - Radiotherapy protection devices
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
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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GONAD, X-RAY SHIELD

Definition

A personal protective device intended to shield the gonads of an individual (i.e., a device operator, patient, or other attending person) from unnecessary exposure to radiation from diagnostic medical procedures by providing an attenuating barrier to the radiation.

Synonym

half-apron

Specifications

Quality standards

  • EN 61331-1, 2014, Protective devices against diagnostic medical x-radiation - Part 1 : Determination of attenuation properties of materials
  • EN 61331-3, 2014, Protective devices against diagnostic medical X-radiation - Part 3 : Protective clothing, eyewear and protective patient shields
  • ISO 8194, 1987, edition 1, (confirmed 2019) Radiation protection - Clothing for protection against radioactive contamination - Design, selection, testing and use

Material

  • Polymer made from lead-free composite materials
  • Inside lining: woven nylon
  • Outer lining:

Technical specifications

  • Protection: equivalent to 0.35 mm of lead
  • Wide and strong Velcro closure
  • Unisex model

Dimensions

Comes in 3 sizes:

  • EDIMGONS1A- => for adult (+/- 40 x 45 cm)
  • EDIMGONS1C- => for child (+/- 30 x 30 cm)
  • EDIMGONS1N- => for neonate (+/- 20 x 25 cm)

Instructions for use

Maintenance

  • Clean with cold soapy water (neutral soap) with a damp cloth, rinse and let dry away from sunlight.
  • Disinfect if needed with a 0.25 % detergent-disinfectant solution for surfaces (i.e. 20 ml = 1 sachet = 1 stroke of dosing pump for 8 l water). Do not rinse (contact time must be 15 minutes minimum and the product is not corrosive).
  • Do not machine wash, do not dry-clean, do not iron, do not sterilise by steam autoclave.

Storage

  • Temperature < 35ºC, Protect from sunlight
  • Do not fold (but may be rolled up)

MSF requirements

Ensures optimal protection of the patient's genitals during x-ray examinations.

Light weight, lead-free protective apron.

Multipurpose model.

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