Standards and Regulations

“Sharpsmart are broadly recognised as the market leader. Having worked with them for 8 months I can see why”

Chaz Scholefield, Waste Manager, The Queen Elizabeth Hospital King's Lynn NHS Trust

 

Sharpsmart’s aim is to meet or exceed all applicable international and UK standards for clinical waste and sharps disposal and to comply with all regulations relating to its operations in any given regulatory jurisdiction.

 

The management of sharps disposal, clinical, pharmaceutical and cytotoxic waste is highly regulated due to the potentially hazardous nature of the materials involved. Sharpsmart continuously monitors all relevant laws and regulations locally and internationally and works hard to ensure its products and services are fully compliant. Healthcare professionals understand the importance of reducing risk in their workplace. It is important that they understand and trust the products and services they use in their everyday tasks. The following are examples of applicable Standards and Regulations:

 

Clinical, Pharmaceutical and Sharps Container Standards

 

British Standard BS EN ISO 23907:2012 Specification for sharps containers

FDA (510K Notification) which is required for all disposable and reusable sharps containers. Sharps containers are classified by the FDA as a Class II medical device.

CAN/CGSB-43.125 Packaging of Category A and Category B infectious substances (Class 6.2) and clinical, biomedical or regulated medical waste 

CSA Z317.10 Handling of healthcare waste materials 

United States ASTM F2132-01 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

United States ECRI Guidelines for Sharps Containers

United States NIOSH Selecting, Evaluating, and Using Sharps Disposal Containers

French Standard NFX 30-500

Australia/New Zealand Standard AS/NZS 4261 Reusable Containers for the Collection of Sharp Items in Human and Animal Medical Applications

Australia/New Zealand Standard AS/NZS 4478 Guide to the Reprocessing of Reusable Containers for the Collection of Sharp Items used in Animal Clinical/Medical Applications

Australian Standard AS 4031 Non-reusable Containers for the Collection of Sharp Medical Items used in Healthcare Areas

South African Standard SANS 452 Non-reusable and reusable sharps containers

 

 

Clinical Waste Handling & Associated Regulations

 

2003, The Environmental Protection (Duty of Care) (England) (Amendment) Regulations, HMSO

1991, The Environmental Protection (Duty of Care) Regulations 1991, HMSO.

1990, The Environmental Protection Act, HMSO.

2011, Technical Guidance WM3: Hazardous Waste – Interpretation of the definition and classification of hazardous waste, Environment Agency, SEPA, NIEA

2009, Waste Batteries and Accumulators Regulations, HMSO

2009, The Hazardous Waste (England and Wales) (Amendment) Regulations, HMSO

2005, The Hazardous Waste (England & Wales) Regulations 2005, HMSO.

2005, Hazardous Waste – Interpretation of the definition and classification of hazardous waste, Environment Agency/Scottish Environment Protection Agency/Environment & Heritage Service.

2005, A Guide to the Hazardous Waste Regulations: Records, Registers and Returns, Environment Agency

2005, A Guide to the Hazardous Waste Regulations: Consignment Notes (version 1.8), Environment Agency

2002, The Control of Substances Hazardous to Health Regulations (COSHH), HMSO

1999, Control of Substances Hazardous to Health Regulations, Stationery Office.

1994, Health and Safety at Work etc.  Act 1974, HMSO.

1992, Management of Health and Safety at Work Regulations 1992, HMSO.

EPR 5.07 - Clinical Waste Guidance

UN 3291, Clinical Waste (Bio Medical Waste or Regulated Medical Waste)

2011, The Waste (England and Wales) Regulations, HMSO

2011, Safe Management of Healthcare Waste England  2013 DOH.

2014, National Guidance for Healthcare Waste Water Discharges, Water UK – UK Water and Sewerage Services

2011, How to comply with your environmental permit. Additional guidance for: Clinical Waste (EPR 5.07), version 1.1, Environment Agency

2010, The Environmental Permitting Regulations (England and Wales), HMSO

2010, Guidelines on the Handling and Disposal of Hospital Pharmacy Wastes (For England and Wales and Information for Scotland and Northern Ireland), NHS Pharmaceutical Quality Assurance Committee

2008, The Health and Social Care Act: Code of practice on the prevention and control of infections and related guidance, Department of Health

2007, HTM 07-06: Disposal of Pharmaceutical Waste in Community Pharmacies, Department of Health.

HTM 07-01  2013: Safe Management of Healthcare Waste, Department of Health.

2005, Guidance for Dentists on Waste Dental Amalgam, DEFRA

2000, Healthcare Waste Minimisation – A Compendium of Good Practice, Department of Health

ISO 9001 (Quality Management Systems)

ISO 14001 (Environmental Management Systems)

OHSAS 18001 (Occupational Health and Safety Management)

ISO 23907:2012 Sharps injury protection -- Requirements and test methods -- Sharps containers

2009, The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations, HMSO (ADR)

2005, The Waste Management Licensing (England and Wales) (Amendment and Related Provisions) Regulations, HMSO

2005, The List of Wastes (England) Regulations, HMSO

2005, The List of Wastes (England) (Amendment) Regulations, HSMO

2005, The Landfill (England and Wales) (Amendment) Regulations, HMSO

2004, The Control of Substances Hazardous to Health (Amendment) Regulations, HMSO

1994, The Waste Management Licensing Regulations, HMSO

1992, The Controlled Waste Regulations, HMSO

2007, The Waste Electrical and Electronic Equipment (Amendment) Regulations, HMSO 2007, HTM 07-05: The Treatment, Recovery, Recycling and Safe Disposal of Waste Electrical and Electronic Equipment, Department of Health.

2006, The Waste Electrical and Electronic Equipment Regulations, HMSO