General Description:

Sharps containers constructed of material resistant to penetration and leakage in accordance with ISO23907:2012, compact in size allowing free space, freestanding, lid premounted, one piece with aperture and open and close day lid, with total capacity between 7.0 to 10.0 L, portable,with or without handle, single-use.

Intended use: safely and efficiently contain, transport and store used limited number of small sharps (ex. Lancets and needles) at the point of

use and until final destruction

Technical specifications:

Functionality: the sharps container must safely contain contaminated sharps at the point of use; during temporary storage and during handling

and transport to the point of treatment and final disposal.

Container stability: Upright, stable during use on a horizontal surface and do not topple over when tested accordance to ISO23907:2012

Container: pre-mounted can with lid

Resistance to damage or leakage: no evidence of leakage and no breach of the sharps containment area when tested in accordance to ISO23907:2012

Resistance to penetration: when tested in accordance to ISO23907:2012

Total Capacity: between 7.0 to 10.0 L

Fill line indicator: Preferably with a fill line indicator marking the maximum filling volume at a level no greater than 85 % of the total capacity of the container and determined by the design of the container and considering the risk of sharps extending above the fill line.

Aperture: designed to minimize the potential for accidental sharps injuries during placement of sharps into the container. Allow single
hand placing of sharps and designed to restrict hand entry and removal of contents from the container.

Closure feature: Integrally attached capable of being closed without the risk of sharps injury to the user. The permanent closure, once activated, preferably, is resistant to manual opening.

Lid: premounted and one piece with aperture

Color: Container can: yellow.

Standards:

Product and packaging: fully comply with ISO23907:2012

Quality management system (QMS): Products and manufacturer must be certified and comply with ISO 9001 requirements (or equivalent).

Packaging and labelling

Primary packaging: One box

Marking or labelling on the container is visible and easily legible and include the following information.

• A clear indication of the fill line

• Appropriate hazard symbols.

• The word "DANGER" or the equivalent wording in English

• Identification of the specific use (where applicable) of the

container (An indication that the container is not re-usable.

• Identification of the total and/or fill volume of the container.

• Name and address of the manufacturer

• Name and/or registered trade-mark of the manufacturer including

product code or model number

• Lot or batch identification.

Secondary packaging

Protective packaging of a sturdy export quality, and of a commercial standard that will provide adequate protection of the goods for carriage
by air, sea and/or road to final destinations worldwide, including remote locations under adverse climatic and storage conditions, and high
humidity - i.e. not less than 17kN edge crush resistance with minimum 60% remaining with 90% humidity at a temperature of 40C (tropical
conditions)

Labelling on the secondary packaging

• Name and address of the manufacturer.

• Manufacturer's product reference.

• Name and/or registered trade-mark of the manufacturer

• Description of the contents, including Type of product and main

characteristics

• The number of units per secondary packaging

• Gross Weight;

• Cubic Measurement;

• Batch Number Reference (if applicable);

• Manufacturing Date (if applicable);

• Manufacturer's instruction for use given either on the package or on a separate insert

Instructions for use

Instructions for use, required for the safe assembly, use, closure,handling and storage of the container, shall be made available by the

manufacturer. The instructions for use should minimize the potential for accidental sharps injury. Drawings, pictograms or other graphical aids may be used where applicable.

Instructions for use shall include the following, as applicable:

• instructions for proper and secure assembly of the container before use correct method for placement of the sharp in the container;

• correct filling of the container to the fill line, including specific instructions not to overfill;

• correct, verifiable closure of the container when the contents have reached the fill line;

• correct procedure for lifting or handling the container when it has been filled (to fill line only) and closed as per manufacturer’s instructions;

• any other warnings or precautions that the manufacturer deems appropriate to assist the user in the safe use of the container.

Useful links

http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue
/categorypage.aspx?id_cat=39