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

These standards include:

• UN Type approval
• BS 7320:1990
• AS4031:1992
• NF X 30-500: Dec. 1999

• 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 from 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 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?

British Standard BS7320:1990
Scope of the standard...

1. Construction - Details the handle, aperture and closure requirements
2. Resistance to Penetration - Average of 15 Newton's and not less than 12.5 Newton's
3. Vertical Drop / Leak Test - Drop test onto from a height of 1 metre after conditioning at 20° C. The container is filled to a weight equal to 40% of the maximum capacity with non-absorbent material plus water equal to 5% of the maximum capacity. The container is allowed to fall freely and left for 5 minutes. The test is repeated 5 times
4. Topple Test / Leak test - Fill with water equal to 5% of the containers maximum capacity
5. Maximum fill-line volume - 70 - 80% of the containers maximum volume.
6. Labelling - Clearly detailed specification
7. Colour - Predominately Yellow
8. Handle -Suspension test when filled to max. capacity expressed in kilograms

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 Newton's
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 Newton's and not less than 12.5 Newton's
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

Standards:

1. UN Type Certification;
2. BS7320:1990;
3. AS 4031:1992;
4. French NF X 30-500

Standard	(1)	(2)	(3)	(4)
Sharpak COMPACT
Sharpak COMPACT 'O'
Sharpak COMPACT HYDRI			?
Sharpak NX5
Sharpak 18 VISI
Sharpak 18 Visi HYDRI			?
Sharpak 35 PLUS
Sharpak 60 PLUS
Sharpak 60 PLUS HYDRI			?
Sharpak 120 PLUS
Sharpak 120 PLUS HYDRI			?
Sharpak 220 PLUS				-
Sharpak 220 PLUS HYDRI			?	-
Sharpak XL				-
Sharpak XL Tonsillectomy				-

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

? - In the case of the HYDRI products the closures and labels are purple in colour rather than the complete units as per AS 4031:1990

TBC - The container is currently under test against the French Standard NF X 30-500

Click the following for more information about Steam Sterilisation and Incineration of SHARPAK HEALTHCARE products

Steam Sterilisation Data Sheet (PDF: 84 KB / 1 page)
Incineration Data Sheet (PDF: 80 KB / 1 page)

Steam Sterilisation Data Sheet (PDF: 84 KB / 1 page)
Incineration Data Sheet (PDF: 80 KB / 1 page)