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RADIATION SHIELDING COLLAR, 0.5 mm Pb equivalent, w/collar

https://unicat.msf.org/cat/product/12595
STD EDIMCOLL1--

Valid Article

Former Code(s): -X EDIMTHYR1--
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.
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
CT30
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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RADIATION SHIELDING COLLAR

Definition

Collar used to protect the thyroid gland against ionizing radiation during x-ray exposure.

Forms part of the protective clothing that must be worn by the staff and patients' attendants when taking x-rays.

Synonym

thyroid collar

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 0.5 mm of lead
  • Full protection from the neck up to collarbones, adapted to the apron
  • Wide and strong Velcro closure
  • One size

Instructions for use

Always make sure there is no unprotected area between the thyroid shield and the apron since the thyroid gland is particularly sensitive to ionizing radiation.

Once a month, visually check for possible damage (tears/ cracks). Once a year, take a radiograph of the collar. In the event of radiation signs via cracks in the lead, the collar is porous and must be replaced.

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 sterilize by steam autoclave.

Storage

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

MSF requirements

Ensures optimal protection of the thyroid gland during x-ray examinations.

Light weight, lead-free protective apron.

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