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Decontamination References

The documents detailed below may not be comprehensive when considering the complete decontamination process but should form a good basis of knowledge.  It is recommended that advice is obtained regarding the status of these documents as they may have been revised or superseded since the list was compiled.

Codes of Practice

  • Health and Social Care Act: 2012 Code of practice for the prevention and control of healthcare-associated infections.

Department of Health Publications

  • Health Technical Memorandum 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care (HTM 01-01).  Part A: The formulation of local policy and choices manual. 
  • Health Technical Memorandum 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care (HTM 01-01).  Part B: Common elements. 
  • Health Technical Memorandum 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care (HTM 01-01).  Part C: Steam sterilization. 
  • Health Technical Memorandum 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care (HTM 01-01).  Part D: Washer disinfectors.
  • Health Technical Memorandum 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care (HTM 01-01).  Part E: Alternatives to steam for the sterilization of reusable medical devices
  • Health Technical Memorandum 00 – Policies and principles of healthcare engineering
  • HTM 01-04 – Decontamination of linen for health and social care, guidance for linen processors implementing BS EN 14065
  • HTM 01-06 – Decontamination of flexible endoscopes: Policy and management
  • HTM 01-06 – Decontamination of flexible endoscopes: Design and installation
  • HTM 01-06 – Decontamination of flexible endoscopes: Operational Management
  • HTM 01-06 – Decontamination of flexible endoscopes: Testing methods
  • HTM 01-06 – Decontamination of flexible endoscopes: Validation and verification
  • Health Technical Memorandum 01-05 – Decontamination in primary care dental practices
  • Health Building Note 13 – Sterile services department
  • Health Technical Memorandum 03-01 – Specialised ventilation for healthcare premises.  Part A – Design and validation
  • Health Technical Memorandum 03-01 – Specialised ventilation for healthcare premises.  Part B – Operational management and performance verification

Acts and Regulations

  • Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009
  • Control of Substances Hazardous to Health Regulations (COSHH) 
  • Management of Health and Safety at Work regulations 1999
  • Pressure Systems Safety Regulations, 2000

British Standards

  • BS EN 285:2015 + A1:2008, Sterilization. Steam sterilizers. Moist heat. Large sterilizers. British Standards Institution
  • BS EN 9001:2015, Quality management systems. Requirements
  • BS EN ISO 13485:2012, Medical devices. Quality management systems. Requirements for regulatory purposes.
  • BS EN 14971:2012 Medical devices. Application of risk management to medical devices
  • BS EN ISO 15883-1:2009. Washer-disinfectors. General requirements, terms and definitions and tests
  • BS EN ISO 15883-2:2009. Washer disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. 
  • BS EN ISO 15883-3:2009. Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
  • BS EN ISO 15883-4:2009. Washer-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
  • BS EN ISO 17665-1:2006. Sterilization of healthcare products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN 60584-3:2008. Thermocouples. Extension and compensating cables. Tolerances and identification system
  • BS EN 60584-1:1996. Thermocouples. Reference tables
  • BS EN 60584-2:1993. Thermocouples. Tolerances
  • BS EN ISO 15223-1. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
  • BS 3970-2:1991. Sterilizing and disinfecting equipment for medical products.  Specification for steam sterilizers for aqueous fluids in sealed rigid containers
  • BS 3970-5:1990. Sterilizing and disinfecting equipment for medical products. Specification for low temperature steam disinfectors
  • BS 3970-1:1990. Sterilizing and disinfecting equipment for medical products. Specification for general requirements
  • BS EN 13060:2014 + A2:2010.  Small steam sterilizers
  • BS 2646-1:1993. Autoclaves for sterilization in laboratories. Specification for design, construction, safety and performance
  • BS 2646-2:1990. Autoclaves for sterilization in laboratories. Guide to planning and installation
  • BS 2646-1:1993. Autoclaves for sterilization in laboratories. Specification for design, construction, safety and performance
  • BS 2646-5:1993. Autoclaves for sterilization in laboratories. Methods of test for function and performance
  • BS 16442:2015. Controlled Environment Storage Cabinet for Processed Thermolabile Endoscopes
  • BS EN ISO 11138-3:2009. Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes
  • BS EN ISO 11138-4:2006. Sterilization of health care products. Biological indicators. Biological indicators. Biological indicators for dry heat sterilization processes
  • BS EN ISO 11138-1:2006. Sterilization of health care products. Biological indicators. General requirements
  • BS EN ISO 11138-2:2009. Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
  • BS EN ISO 11138-5:2006. Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
  • BS EN ISO 11140-5:2007. Sterilization of health care products. Chemical indicators. Class 2 indicators for Bowie and Dick-type air removal tests
  • BS EN ISO 11140-4:2007. Sterilization of health care products. Chemical indicators. Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
  • BS EN ISO 11140-3:2009. Sterilization of health care products. Chemical indicators. Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
  • BS EN ISO 11140-1:2009. Sterilization of health care products. Chemical indicators. General requirements

Other Documents

  • EU Council Directive.  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Awareness of these documents is part of the AVM induction process and specific documents underpin the decontamination training courses we provide.