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Document No.
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DHSV Sterilisation Services AS/NZS 4187:2014
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Client / Site
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DHSV Sterilisation Services: AS/NZS 4187:2014 Compliance Audit
Detail and content in 'policy' other documents and records
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1. There is an organisational policy for cleaning RMDs, disinfection of RMDs and sterilisation of RMDs<br><br>
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2. There is a policy for initial pre treatment of used RDMs prior to their return to the reprocessing facility. The maximum period of time permitted to elapse between use; and initial cleaning of the RMD is specified.
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3. There is a policy for the collection and transport of used RMDs from point of use.<br>Content includes protection of the RMDs and prevention of contaminated or harm to personal and environment.
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4. Policy directs that all RMDs which have been opened (but not used) are subjected to all stages of the reprocessing procedures.
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5. There is a policy for handling specialised RMDs, loan and trial instruments.
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7. Content within purchasing policy policy is consistent with 2.4.2 parts a-h.
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6. There is a policy for purchasing reprocessing equipment, RMDs and accessories including critical consumables, policy directs how new RMDs are introduced into circulation.
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8. There is a policy instructing the process for disinfection of cleaned RMDs.
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9. There is a policy for routine monitoring and control of cleaning, disinfecting and sterilising processes.
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10. There is a policy for handling, transport and storage of reprocessed RMDs.
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11. There is a policy for cleaning the reprocessing equipment.
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12. There is a policy for the loading and unloading of the cleaning equipment.
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13. There is a policy for inspection, assembly and testing (if applicable) and packaging of RMDs prior to disinfection and prior to sterilisation.
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14. There is documented instructions for assembly of RMDs into trays or sets. Content instructs that RMD are not packaged with tubing or textiles and RMDs with hinges and ratchets are assembled in the unlocked position.
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15. There is a policy guiding the use of internal indicators (if used).
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16. There is a policy for sterilisation of RMDs consistent with parts a-e of 6.5.2.
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17. There is a policy directing traceability of reprocessed semi-critical and critical RMDs.
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18. The policy for release includes documented criteria consistent with table 9.1.
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19. Policy directs the investigation of nonconforming RMD, the action to be taken when nonconforming RMD are detected; the corrective and preventative action, recall (if necessary); review the deviation reports and indicators of nonconformances and re-evaluation to verify the cause of nonconformity is resolved.<br>
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20. Policy documents the minimum cleaning and high level disinfection process when sending non conforming RMD off site for repair or maintenance.
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21. There is a policy that says medical devices labelled single use are not reprocessed or reused.
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22. There is a policy for qualification and requalification of reprocessing equipment (cleaning, disinfecting and sterilising) content includes specific procedures for requalification.
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23. RMDs are classified into product families and the classification is documented and validated.
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24. There is a copy of the validation report in the department for each WD. This report indicates that the WD has passed IQ, OQ & PQ. ( Note; major repairs and relocation of the WD the IQ,OQ & PQ report must be dated after the move). Requirements for the report are specified in section 7.5.
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25. There is a requalification report showing each WD has passed PQ ( if report > than 12 months score as not met.
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26. Ancillary items for the WD have been supplied and installed in accordance with their specification.
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27. There is a copy of the validation report in the department for each steriliser. This report indicates that the Steriliser has passed IQ, OQ & PQ. ( Note; major repairs and relocation of the Steriliser the IQ,OQ & PQ report must be dated after the move). Requirements for the report are specified in section 7.5.
Evaluating documents records and quality.
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28. There is requalification report showing each Steriliser has passed PQ (if report > 12 months old score as Non Compliant
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29. The biological indicators used on sterilisers during PQ demonstrate compliance with parts I-IV of 7.4.5 & ISO 11138-1
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30. Each type of packaging has been validated and incorporated into annual PQ.
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34. (IQ) There is evidence of a 'Certificate of Calibration' from the heat sealing equipment manufacturer.
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35. There is a documented program/calendar, of preventative maintenance of all reprocessing equipment. There are documented records of maintenance.
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36. The organisation monitoring and measuring equipment is calibrated using NATA accredited equipment, and as specified inspection 2.4.4.1. ( if using external contractor; the agency has confirmed that NATA accredited equipment is used). There are calibration reports for each piece of monitoring and measuring equipment.
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37. There is documented contingency procedure in case automated cleaning equipment is unavailable. This instructs the acceptable alternative cleaning processes or whether an item is to wait until an automated cleaning system is available.<br>(Confirm sterilisation staff are aware of the process to pass.)
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38. Records are kept of the repair and action taken when non conforming and faulty equipment is unavailable.
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39. There are purchasing records for the RMDs; and reprocessing equipment.
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40. There are records of periodic 'in house' audits to evaluate compliance with AS/NZS4187:2014.
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41. The <br>Manager (however named) directly responsible for the reprocessing of RMDs within the facility meets the requirement specified in parts a-e of 2.3.3.
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42.There is a formal induction and orientation program for all Staff as listed in Section A2.3.3.
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43. Staff complete periodic reassessment of competencies for reprocessing activities. These are assessed by a Senior qualified staff member. Documented records are kept.
Evaluating practices (and evidence of compliance with documented policy).
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44. Entry to the reprocessing is restricted, doors are to be closed. Delivery of contaminated items and collection of RMDs required for the session/day only time non-sterilisation staff can enter the unit.
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45. Hand hygiene facilities are available and accessible in all work areas.
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46. Hand cream is not used when performing reprocessing activities.
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47. Personal protective equipment (PPE) is easily accessible and worn in each of the work areas.
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48. The reprocessing environment has distinct and separate physical segregation of the cleaning from the other reprocessing areas ( ie packing/ sterilisation/ cooling/ storage). The work flow is unidirectional from dirty to clean.
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49. The reprocessing environment is protected and controlled. (Includes temperature 18-25c, humidity35-70%, controlled traffic flow, directed workflow from dirty to clean and airflow is from clean to dirty) so that the integrity of the sterilisation are not compromised. process and the integrity of the packaging
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50. All work surfaces, fittings, fixtures, windows, shelving and furniture are constructed of robots non shedding materials that are easy to clean and maintain. ie non opening windows, junctions between walls and floors are coved and flush.
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51. There is task lighting and magnification. Ceiling lights are flush and fitting.
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52. Sinks are of sufficient diameter and depth to fully immerse the RMD. Sinks are ergonomically designed. sinks are dedicated for pretreatment and manual cleaning and rinsing of RMD. These sinks are not used for any other purpose.
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53. There are facilities to enable water or air flushing of lamented RMD at the RMD cleaning sink.
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54. The reprocessing facility is cleaned in accordance with the documented procedure and schedule. The area is maintained in a hygienic state at all times. Separate dedicated cleaning equipment is provided for both dirty and clean work areas.
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55. There are procedures for cleaning all equipment used to transport used RMD.
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56. A dedicated area is provided for the storage of reprocessed RMDs that have been released for use. The storage areas for RMDs are controlled as per 5.6.9 and part a-I of A 9.5.<br>Storage - sterile supplies. Sterile supplies must be handled and stored in a manner that maintains the integrity of packs and prevents contamination from any source ( dust, vermin, sunlight, water, condensation, etc.) Storage areas must be temperature and light controlled and easily cleaned. Supplies should be stored off the floor to avoid mechanical damage during cleaning.
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57. The sterile storage area is HEPA. The sterile storage room has a positive pressure gradient to other rooms. Air supply to sterile store, set up rooms and operating rooms is not recirculated from any other enclosure.
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58. New RMD, RMD returned for loan/ repair or loanRMD are fully reprocessed by a validated cleaning, disinfection and sterilisation process in accordance with the RMD manufacturer's reprocessing instructions.
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59. All staff adhere to the HSO policy specifications for the cleaning and disinfecting RMD.<br>(This is asking for evidence staff practices are consistent with HSO documented policy and procedure.)
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60. RMD are disassembled prior to pre treatment.<br><br>(This is asking for evidence staff practices are consistent with HSO documented policy and procedure.)
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61. RMD are segregated to allocated cleaning pathways (manual, ultrasonic/ WD or WD only).<br><br>(This is asking for evidence staff practices are consistent with HSO documented policy and procedure.)
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62. Manual cleaning of RMD is limited to pre treatment prior to reprocessing in a washer/ disinfector, or where the manufacturer's validated cleaning instructions require manual cleaning only.
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63. Cleaning and disinfection or sterilisation of RMDs is performed between uses including when single use sheaths/ sleeve or protective barriers are used.<br>(check single use sheaths/sleeves/barriers for RMDs are not used a substitute for reprocessing).
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64. RMDS are cleaned in accordance with the validated cleaning instructions provided by the RMD manufacturer.
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65. There is evidence that all cleaning agents, instrument grade chemical disinfectants and liquidising sterilising agents used on RMDs are registered with TGA for that prupose
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66. There is evidence that RMDs are reprocessed to the highest possible level using Spaulding classification system.
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67. Disinfectants or sterilising agents used outside the range of conditions specified by the supplier have undergone a fullvalidation. VAlidation has proved the microbiocidal effectiveness of the disinfecting / sterilising process.<br>These procedures are documented and approved by the designated responsible person.
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68. There are detailed specifications from the manufacturers for the processes delivered by the cleaning and disinfection equipment. (Ultra sonic, lubricator, washer/disinfector).
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69. Where the RMDs Manufacturers cleaning instructions specify the use of a ultra sonic, an ultra sonic is used.<br>If ultra sonic not available when required then the score is Not Met
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70. The ultrasonic is compliant with Australian Standards and is commissioned as per AS 2773.2 section 6.3
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71. There is evident that the performance of the ultra sonic cleaners is monitored each day of use.
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72. Visible soiling is removed from the RMD prior to being processed in an ultra sonic cleaner.All RMD processed in the ultrasonic are subject to further manual or mechanical cleaning processes.
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73. Ultrasonic is emptied and cleaned at least daily and more frequently if contaminated.<br>Flushing type ultrasonic cleaners are operated for a full cycle with fresh water and detergent but without a load at the end of the day's work and then emptied and left dry until required for subsequent use.
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74. The water supplied is of a suitable s defined not table 7.2 for cleaning and disinfection.
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75. The WD manufacturer instructions regarding the water quality requirements are implemented ie softened, filtered, demineralised, reverse osmosis or distilled water. ( should occur prior WD installation).
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76. The water quality in the WD is tested monthly by a NATA accredited water tester. (Table 7.2 final rinse water) and non conformance is actioned.
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77. The water temperature in the WD is checked each cycle- <br>Parameters are consistent with table 6.1<br>(confirm the printout has been checked and signed).
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78. The inflowing water during the flushing stage the WD is maintained below 45 C to avoid protein coagulation.<br>(Temperatures higher than 45C can cause protein coagulation and cleaning problems).
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79. There is evidence that the chemical dosing volumetric test is performed quarterly on WD
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80. There is evidence a validated objective means of assessing the performance of the WD cleaning process. Using methods from ISO 15883 series.<br>Routine regular soil ( or other ) tests.
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81. Following automated cleaning the RMD is visually inspected and checked to ensure it is clean (soil test results if used
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82. Evidence is provided to indicate the quality of the final rinse water in the WD is free of chemical residue and microbial contamination examples could include Ph test/ water testing / ATP bioluminescence.
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83. WD, loading racks, trolleys, ultrasonic cleaners, drying cabinets and other accessories are cleaned in accordance with Manufacturers instructions.
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84. Brushes and other accessories used for pre-treatment or manual cleaning are cleaned and thermally disinfected or sterilised at least daily.
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85. There is a traceability system for all high level chemical disinfection that contains all elements as listed in part a(i-vii) of 2.4.3.2, where electronic records are kept, there are procedures in place to verify attainment of process parameters at the conclusion of each cycle.
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86. Water quality as defined by manufacturer and Table 7.2 AS/NZS 4887:2014
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87. Sterile or filtered water through a 0.22um sterilising grade filter is used for rinsing instruments attended for use in sterile cavities, in known immune-compromised patients or for invasive procedures e.g. ERCP and brochoscopy.
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88. Methods used for drying RMDs do not compromise the cleanliness of the RMD<br>If drying cabinets are unavailable low lifting cloths or instrument grade compressed air.
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89. Records indicate the drying cabinet is checked daily and operating within specified limits<br>(Limits are references to manufacturer'sinstructions and AS 2774 & AS 2514)
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90. A technical manual for drying cabinets containing all information required as listed in AS 2514 5.3(a-j) is available.
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91. Each drying cabinet has passed annual performance test on two successive occasions as listed in AS 2514 rendering the test load completely free of moisture.
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92. Accessories :tray liners, tip protectors and other materials that are used for the assembly and presentation of packaged RMD are manufactured for that purpose.
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93. Packaging systems - PSBS (sealable pouches, reels). SBS (Sterilisation wraps - woven or non woven). PSBS (Reusable containers). All meet criteria defined in Table 9.1.
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94. Sealing methods for SBS ensure the integrity and maintain sterility of the RMD until point of use as per 6.4.2. Note self adhesive pouches cannot be validated, select 'partial' if using these pouches.<br>There should be no evidence of string, nonadhesive tape, staples, pins or elasticised bands. The ,ethos of sealing should also be tamer evident.
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95. The heat sealer has annual or more frequently recommended by the manufacturer thermometric testing, maintenance and re calibration.
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96. For heat sealed pre-formed sterile barrier system (SBS) the sealing process parameters and their tolerances is specified and documented as per Manufacturers instructions.
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97. There is evidence the heat sealing equipment has undergone PQ & OQ indicating it is consistently produces conforming SBS.
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98. A daily check of the seal of one or more samples of the SBS is performed by visual integrity of the seal integrity over the entire length of the seal before and after the sterilisation process.
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99. Impulse and rotary heat sealers without a process record: there is a daily record of temperature setting. Visual checks of temperature setting are made immediately prior to each episode of sealing.
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100. Rigid reusable containers are inspected, used and cleaned according to the manufacturer's instructions.
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101. The packaged RMD is labelled prior to sterilisation as per 6.4.2.
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102. There is a copy of the manufacturer's specification for the steriliser.
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103. A dedicated area is provided within the steriliser unloading zone for cooling, and where applicable, aeration of sterilised RMDs.
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104. There are sterilising process records as per 2.4.3.2 (b i-vii).
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105. Prior to release of an RMD from each process ie cleaning, disinfection and sterilisation, the cycle record is checked to verify the parameters have been met in accordance with Table 9.1. Non conforming RMD are not released.
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106. Records are kept force identification and traceability of semi critical RMD undergoing high level chemical disinfection.
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107. Routine monitoring of low temperature sterilisation systems is conducted and recorded in accordance with Table 8.2.
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108. Criteria for the release of the RMD using low temperature sterilisation systems comply with Table 9.1.
