Ethylene Oxide Sterilisation SWMS
Use, handling, and maintenance of ethylene oxide gas sterilisation equipment in CSSD departments, hospital sterilisation units, and contract sterilisation facilities. Covers cylinder change, chamber loading/unloading, degassing, and routine maintenance.
SWMS variants reference your state’s WHS legislation. Instant download after payment.
Ethylene oxide (EtO) sterilisation is used in Central Sterile Services Departments (CSSD), hospital sterilisation units, and contract sterilisation facilities to process heat- and moisture-sensitive medical devices. The work involves handling pressurised EtO cylinders, loading and unloading sterilisation chambers, managing degassing aeration cycles, and performing routine maintenance on sterilisers, abators, and exhaust systems. EtO is classified by IARC as a Group 1 human carcinogen, is a confirmed reproductive and germ-cell mutagen, and has been reclassified by Safe Work Australia under the National Toxicants Governance Committee (NTGC) framework — effective 1 December 2026, no numerical Workplace Exposure Standard applies and exposures must be reduced to as low as reasonably practicable (ALARP).
This Safe Work Method Statement has been prepared in accordance with the model Work Health and Safety Act 2011 and the WHS Regulations 2017 (NSW) / equivalent state regulations, specifically Part 7.1 (Hazardous Chemicals) and Part 3.1 (Managing Risks to Health and Safety). It also aligns with AS/NZS ISO 11135:2019 'Sterilisation of health-care products — Ethylene oxide' and the Code of Practice: Managing Risks of Hazardous Chemicals in the Workplace.
A SWMS is legally required where this work is classified as High Risk Construction Work under Schedule 3 of the WHS Regulations, and is also required under the PCBU's primary duty of care (s.19 WHS Act) wherever workers are exposed to a Schedule 10 / NTGC-listed prohibited or restricted carcinogen. Failure to prepare, communicate, and implement a SWMS exposes the PCBU to Category 1–3 offences under the WHS Act with penalties up to $3.85 million for a body corporate.
Hazards identified
6 hazards covered, sorted by priority.
Acute pulmonary oedema, central nervous system depression, chemical burns to airways; long-term exposure causes leukaemia, lymphoma, and breast cancer (IARC Group 1)
Chronic low-level exposure to operators handling loads; reproductive toxicity, mutagenic effects on germ cells, sensitisation
Catastrophic facility damage, fatal burns, blast injuries; EtO has a wide flammability range and low autoignition temperature (429°C)
Asphyxiation from nitrogen purge atmospheres, residual EtO exposure, engulfment, entrapment — triggers HRCW Category 5
Musculoskeletal injury, crush injury to feet/hands, cylinder rupture if dropped (becomes a projectile)
Uncontrolled release of EtO to workplace or atmosphere, exceeding ALARP and breaching environmental licence conditions
Control measures
Hierarchy-of-controls order: elimination → substitution → isolation → engineering → administrative → PPE.
- 1Eliminate or substitute where reasonably practicable — assess whether steam, hydrogen peroxide vapour (VHP), or gamma sterilisation can replace EtO for the specific load, in accordance with the hierarchy of control under WHS Reg 36
- 2Install fully enclosed, single-chamber sterilisers with integrated aeration (eliminating manual load transfer) certified to AS/NZS ISO 11135:2019
- 3Continuous fixed-point EtO gas monitoring with audible/visual alarms set at the lowest reliably detectable level (typically 1 ppm action / 5 ppm evacuation) given the absence of a numerical WES post-1 December 2026
- 4Personal passive dosimetry badges for all CSSD operators on every shift, with results recorded in the health monitoring register under WHS Reg 368
- 5Local exhaust ventilation (LEV) at the chamber door, cylinder manifold, and aerator with minimum 10 air changes per hour, ducted to a catalytic abator achieving ≥99.9% destruction efficiency
- 6Permit-to-work system for cylinder change-over, chamber entry, and abator maintenance — including isolation, lock-out/tag-out, and atmospheric testing prior to entry
- 7Confined space entry procedures complying with AS 2865:2009 for any chamber entry, including standby person, retrieval system, calibrated 4-gas + EtO monitor, and rescue plan
- 8Mandatory PPE: full-face air-purifying respirator with EtO-rated cartridge (or supplied-air SCBA for cylinder change/leak response), butyl rubber gloves, chemical splash apron, safety footwear
- 9Health monitoring program under WHS Reg 368 and Schedule 14 — pre-placement, annual, and exit medicals including FBC, reproductive history, and respiratory assessment by a registered medical practitioner
- 10Documented training and competency assessment for all operators covering EtO toxicology, cycle operation, emergency response, and SDS interpretation, refreshed every 12 months
- 11Emergency response procedures including spill kit, evacuation alarm, deluge shower/eyewash within 10 metres, and notification to the regulator under WHS Act s.38 for any uncontrolled release
Applicable Codes of Practice
Mandates risk assessment, control, labelling, SDS, induction, health monitoring, and air monitoring for EtO as a Schedule 10 / NTGC-restricted carcinogen
International standard adopted in Australia specifying validation, routine control, and process requirements for EtO sterilisation of medical devices
Provides regulator-endorsed practical guidance on risk assessment, hierarchy of controls, and ALARP for carcinogens without a numerical WES
Applies to entry into steriliser chambers for maintenance, calibration, or cleaning — defines entry permit, atmospheric testing, and rescue requirements
Governs storage, segregation, securing, and manifold connection of EtO cylinders within the facility
Sets requirements for ventilation, lighting, and emergency facilities (eyewash, deluge) in CSSD areas
High-Risk Construction Work triggered
Ethylene oxide is a Schedule 10 / NTGC-restricted hazardous chemical classified as IARC Group 1 carcinogen, Category 1B mutagen, and Category 1B reproductive toxicant under the GHS. Routine handling during cylinder change, chamber operation, and maintenance triggers HRCW Category 10 under Schedule 3 of the WHS Regulations.
Steriliser chambers meet the AS 2865 definition of a confined space — limited entry/exit, not designed for human occupancy, and contain or may contain a hazardous atmosphere (residual EtO, nitrogen purge). Any entry for cleaning, probe calibration, or breakdown maintenance triggers HRCW Category 5.
Where work is classified as High Risk Construction Work under Schedule 3, WHS Regulation 299 mandates that a SWMS must be prepared before work commences, must be readily accessible to workers, and must be reviewed if controls are revised or an incident occurs. Failing to prepare or comply with a SWMS is an offence carrying penalties up to $6,000 for an individual and $30,000 for a body corporate per breach, with further Category 1–3 offences under the WHS Act 2011 carrying penalties up to $3.85 million and 5 years imprisonment for reckless conduct causing death or serious injury.
Who this is for
- →CSSD managers and sterilisation technicians in public and private hospitals
- →Contract sterilisation facility operators processing medical devices for OEMs
- →Biomedical engineering and facility maintenance personnel servicing EtO sterilisers and abators
- →WHS managers and infection prevention coordinators responsible for hazardous chemical compliance
- →PCBUs and officers with due diligence obligations under s.27 of the WHS Act for healthcare and sterilisation operations
- →Independent auditors and consultants conducting hazardous chemical risk assessments under WHS Reg 35
What you receive
- ✓Fully editable Microsoft Word (DOCX) SWMS document, pre-populated and ready for site-specific tailoring
- ✓State-specific legislation schedule referencing the WHS Act, Regulations, and Codes of Practice applicable in NSW, VIC, QLD, WA, SA, TAS, ACT, and NT
- ✓Comprehensive hazard register with risk matrix scoring (likelihood × consequence) for all identified EtO-related hazards
- ✓Worker sign-on register for daily SWMS acknowledgement and toolbox talk attendance
- ✓Pre-start checklist covering cylinder integrity, LEV operation, gas monitor calibration, and abator status
- ✓Emergency response flowchart for EtO leak, fire, and exposure incidents
- ✓Health monitoring schedule template aligned with WHS Reg 368 and Schedule 14
- ✓Free updates for 12 months as legislation and standards evolve (including the 1 December 2026 NTGC reclassification)
Worked example
At a 450-bed metropolitan hospital CSSD, technician Aisha is rostered to perform a 144-cylinder EtO change-over and run an overnight sterilisation cycle on a load of cardiac catheters. Before commencing, she opens this SWMS on the CSSD tablet, signs on the worker register, and reviews the hazard register with her supervisor during the pre-start toolbox talk. Following the permit-to-work procedure, she dons a full-face APR with EtO cartridges and butyl gloves, isolates the manifold, verifies the LEV is drawing at the cylinder cabinet using the magnehelic gauge, and confirms the fixed EtO monitor reads <0.5 ppm. During change-over, the manifold gas detector spikes to 3 ppm. Aisha follows the SWMS emergency response: she evacuates to the muster point, activates the cabinet purge, and notifies the supervisor. The biomedical engineer attends under a separate hot work / chemical permit, identifies a degraded gasket, and replaces it. Aisha logs the incident in the exposure register, her passive dosimeter is sent for analysis, and the SWMS is reviewed within 24 hours under WHS Reg 38 to confirm whether additional controls are required. Because the SWMS was followed and documented, the PCBU can demonstrate due diligence under s.27 of the WHS Act.
Related legislation
- Work Health and Safety Act 2011 (Cth model) and corresponding state/territory Acts
- Work Health and Safety Regulations 2017 (NSW) / 2011 (Cth model) — Part 3.1, Part 3.2, Part 4.3 (Confined spaces), Part 7.1 (Hazardous chemicals)
- Hazardous Chemicals Information System (HCIS) listing for ethylene oxide (CAS 75-21-8)
- Poisons Standard (SUSMP) — ethylene oxide Schedule classification
- Therapeutic Goods (Medical Devices) Regulations 2002 — for contract sterilisation facilities
- Protection of the Environment Operations Act 1997 (NSW) and equivalents — for licensed EtO emissions to atmosphere
- Dangerous Goods (Road and Rail Transport) Regulations — for EtO cylinder transport (UN 1040, Class 2.3)
Frequently asked questions
What changes on 1 December 2026 with the NTGC reclassification of ethylene oxide?
Safe Work Australia, through the National Toxicants Governance Committee, has reclassified EtO as a substance for which no numerical Workplace Exposure Standard (WES) can be considered safe. From 1 December 2026, the existing 1 ppm 8-hour TWA is withdrawn and PCBUs must demonstrate that exposures are reduced to as low as reasonably practicable (ALARP) using the hierarchy of controls. This SWMS is built around the ALARP framework and includes air monitoring action levels well below 1 ppm.
Is health monitoring mandatory for EtO sterilisation operators?
Yes. Under WHS Regulation 368 and Schedule 14, health monitoring is mandatory for workers with significant risk of exposure to ethylene oxide. This must be conducted by or under the supervision of a registered medical practitioner with experience in occupational health, and must include baseline (pre-placement), periodic (typically annual), and exit examinations. Records must be kept for at least 30 years after the last entry.
Does entering a steriliser chamber for cleaning require a confined space permit?
Yes. Steriliser chambers meet the definition of a confined space under AS 2865:2009 and Part 4.3 of the WHS Regulations. Entry requires a written confined space entry permit, atmospheric testing (oxygen, EtO, and any purge gases), a trained standby person, a documented rescue plan, and confined space entry training for all entrants. This SWMS includes a confined space entry sub-procedure.
Can this SWMS be used in any Australian state or territory?
Yes. The SWMS is built on the model WHS Act 2011 framework adopted by NSW, QLD, VIC, WA, SA, TAS, ACT, NT, and the Commonwealth. The included state-specific legislation schedule cross-references the equivalent regulation numbers and codes of practice for each jurisdiction. Victoria's OHS Act 2004 / OHS Regulations 2017 equivalents are also mapped.
How often must this SWMS be reviewed?
Under WHS Regulation 300, a SWMS must be reviewed and revised if relevant control measures are revised, if an incident occurs, if a new hazard is identified, or if a worker (or HSR) requests a review. As best practice, we recommend a scheduled review every 12 months at minimum, and immediately following the 1 December 2026 NTGC reclassification trigger date.
What respirator is required for EtO cylinder change-over?
For routine cylinder change-over with verified low ambient EtO levels and functioning LEV, a full-face air-purifying respirator fitted with an EtO-specific cartridge (note: standard organic vapour cartridges have very limited service life against EtO) is the minimum acceptable PPE. For leak response, breakdown maintenance, or any situation where EtO concentration is unknown or potentially IDLH (>800 ppm), a supplied-air respirator or SCBA is mandatory under AS/NZS 1715:2009.