compliance

Compliance

All SHARPAK® sharps and DISPOSA® clinical waste containers have been tested and certified to the relevant standards by independent test laboratories including Smithers PIRA and BSI Product testing.

The current standards include:

  • UN Type approval
  • ISO 23907:2012
  • AS4031:1992
  • NF X 30-500: Dec. 1999

What is UN Type approval?

  • Official Title: "The Carriage of Dangerous Goods (Classification, Packaging & Labelling) and Use of Transportable Pressure Receptacles Regulations 1996 (CDGCPL2)"
  • Testing devised for the United Nations for the transport of dangerous goods
  • Sharps waste is classified under UN 3291 Clinical Waste
  • Compliance is a legal requirement when the waste is transported
  • Consignor's responsibility to use correct product
  • Became Law as of 1.1.97
  • Each size of container must have its UN approval number displayed on the container
  • All SHARPAK Containers have been UN type tested by PIRA International

UN Type Approval Testing

Type approval testing is carried out by Smithers PIRA International who are the nominated test laboratory. Approval certificates are issued on behalf of the Department of the Environment, Transport and the Regions, Civil Aviation Authority and the Health and Safety Executive

Cold Drop Test - The container under test is filled with sharps to the fill line capacity and the weight is recorded. The container is then conditioned at -18°C for specified period and then drop tested as per the test protocol from a height of 1.2 metres onto a hard surface

Stack Test - A load is applied to the container equal to the total weight of a stack of filled containers 3 metres high

The regulations relating to UN type approved containers stipulates that the container must be made from virgin raw material, reprocessed material cannot be used

What does the UN Number mean?

un-number

The international standard BS EN ISO 23907: 2012

This defines the requirements for single-use sharps containers, designed for the containment and disposal of sharps such as scalpel blades, trocars, hypodermic needles and syringes. It is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user.

BS EN ISO 23907:2012 defines the following requirements and test methods for Sharps containers:

  • Construction: details the container stability, strength of handle, aperture and closure requirements.
  • Resistance to penetration: not less than 15 Newton’s.
  • Resistance to damage or leakage after dropping from a height of 1m.
  • Fill-line indicator: no greater than 85% of the total capacity of the container.
  • Labelling & instructions for use: the standard includes details for hazard symbols, usage of the container, assembly, placement, filling and handling instructions.
  • Colour: as defined by national regulations.

Disposable Sharps Containers - Australian Standard AS 4031:1992

Scope of the standard:

  1. Construction - Details the handle, aperture and closure requirements
  2. Resistance to Penetration - Not less than 12.5 newtons
  3. Vertical Drop/Leak Test - Drop test from a height of 1 metre after conditioning at 23°C. The container is filled to a weight equal to 40% of the maximum capacity with non-absorbent material PLUS water equal to 6% of the maximum capacity or 60ml whichever is the lesser. The test is performed allowing the container to fall on its top, on two adjacent side walls, on a corner at the top, a corner at the base and the base
  4. Maximum fill volume - A fill line positioned at the recommended fill capacity
  5. Labelling - Clearly detailed specification
  6. Colour - Predominately Yellow * Cytotoxic - predominately Purple
  7. Handle - Suspension test when filled to max. capacity of the container expressed in kilograms

French Standard NF X 30-500 : December 1999

Scope of the standard:

  1. Construction - Details the handle, aperture and closure requirements
  2. Capacity - The standard applies to containers with a maximum effective capacity of up to 10 Litres. (Fill line capacity)
  3. Resistance to Penetration - Average of 18 newtons and not less than 12.5 newtons
  4. Drop Test - Drop test from a height of 1.2 metre after conditioning at 5°C for 24 hours. The container is filled to a weight equal to the maximum gross weight of the containers capacity with non-absorbent material. This fill weight must be greater than or equal to 45% of the real capacity in litres. The test is repeated 5 times
  5. Leak test - Fill with water equal to 5% of the containers maximum capacity. The closure then the locked and the container is placed on its side with the aperture at its lowest point
  6. Maximum fill-line volume - 75 - 85% of the containers maximum volume.
  7. Labelling - Clearly detailed specification
  8. Colour - Predominately Yellow
  9. Handle - Only specifically required on containers above 2 litre capacity
  10. Instruction - Each carton of product must contain a full data sheets containing all the information listed in the standard

Conformance to the standards

 

PRODUCTMax Cap
(litres)
UN Type CertificationISO
23907:2012
AS 4031:1992French NF X 30-500
SHARPAK COMPACT 0.5 tick tick tick tick
SHARPAK COMPACT 'O' 0.5 tick tick tick tick
SHARPAK COMPACT HYDRI 0.5 tick tick dot tick
SHARPAK NX5 0.5 tick cross cross cross
SHARPAK 6 0.6  tick tick   tick  cross
SHARPAK 18 ECO 1.53  tick tick   dot tick 
SHARPAK 18 PLUS 1.58 tick tick tick tick
SHARPAK 18 PLUS HYDRI 1.58 tick tick dot tick
SHARPAK 35 PLUS 3.5 tick tick tick tick
SHARPAK 35 HYDRI 3.5  tick  tick tick  tick 
SHARPAK 60 PLUS 6 tick tick tick tick
SHARPAK 60 PLUS HYDRI 6 tick tick dot tick
PHARMApak 60 PLUS 6  tick  tick  tick  cross
SHARPAK 120 PLUS 12 tick tick tick tick
SHARPAK 120 PLUS HYDRI 12 tick tick dot tick
PHARMApak 120 PLUS 12  tick  tick  tick cross 
SHARPAK 220 PLUS 22 tick tick tick -
SHARPAK 220 PLUS HYDRI 22 tick tick dot -
PHARMApak 220 PLUS 22 tick  tick  tick  cross  
SHARPAK XL 26.3 tick tick tick -
SHARPAK XL Tonsillectomy 26.3 tick tick tick -

 

- The NX5 full meets all the performance requirements with the exception that the container is predominantly grey in colour instead of yellow.

dot

- In the case of the HYDRI products the closures and labels are Purple in colour. However the complete container MUST be purple in colour in the case of the Australian Standard 4031-1992.