GONAD RADIATION SHIELDING APRON, 0.5 mm Pb equivalent, adult
STD
EDIMGONS1A-
Valid Article
Account code:
60100
HS Code:
903300
Last Updated on:
02/06/2024, 22:01:02
Former
Code(s):
ELINOCBZLB0042
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.
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.
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:
- rubber-coated polyester fabric
- strong, flexible and washable
- resistant to a detergent-disinfectant solution
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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