Specification builder · Tier C
Large horizontal pre-vacuum steam sterilizer for hospital CSSD and operating theatres (chamber 2 to 12+ sterilisation units, EN 285)
A large, floor-standing autoclave that uses pressurised saturated steam, with pulsed vacuum air removal, to sterilise wrapped surgical instruments, containers, textiles and other heat-resistant items. It is the main machine of a hospital Central Sterile Services Department (CSSD) and of operating theatre sterile cores. Capacity is stated in sterilisation units (STU, one 300 x 300 x 600 mm basket), from about 2 STU for a theatre suite up to 12 STU or more for a large teaching hospital.
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Standards this specification draws on
- EN 285:2015+A1:2021 The European performance and test standard for large steam sterilizers (1 STU and above); defines STU, air detector, leak test, thermometric and drying tests.
- ISO 17665:2024 Requirements for development, validation (IQ/OQ/PQ) and routine control of moist heat sterilisation processes for health care products.
- EN 13060 Standard for small steam sterilizers (below 1 STU); bidders must not offer EN 13060 bench-top units for a CSSD large-sterilizer item.
- PED 2014/68/EU / ASME BPVC Section VIII Div. 1 Pressure vessel design, manufacture and certification of the chamber, jacket and steam generator.
- IEC 61010-1 and IEC 61010-2-040 Electrical and mechanical safety of sterilizers and washer-disinfectors.
- IEC 61326-1 EMC requirements for laboratory and process control equipment, applies to sterilizer controls.
- EN ISO 11140-1 / -4 Chemical indicators and Bowie-Dick type test packs used for daily testing and load monitoring.
- EN ISO 11138-1 / -3 Biological indicators for steam sterilisation used in validation and routine monitoring.
- EN ISO 13485:2016 Quality management system for medical device manufacturers.
- ANSI/AAMI ST79 / UK HTM 01-01 Widely used guidance for steam sterilisation practice, testing frequency and CSSD design.
Common mistakes in tenders for this equipment
- Writing exact chamber dimensions or cabinet width (e.g. one maker's 660 x 660 x 1000 mm chamber) instead of a minimum STU and usable volume, which excludes equivalent machines.
- Naming proprietary features or sensors (branded air-removal sensors, branded water-saving or software names) instead of describing the function and the measurable performance.
- Mandating one air-removal technology (only liquid-ring pump, or only ejector) when the EN 285 tests are what prove performance.
- Requiring compatibility with an existing brand's loading carts or traceability software without allowing an open data interface, which locks future purchases.
- Accepting an EN 13060 bench-top or a 'meets EN 285 test methods' self-declaration in place of EN 285 type-test evidence for a CSSD machine.
- Leaving RO water treatment, loading carts, barrier-wall flange, voltage stabiliser and validation out of scope, so the lowest bidder later adds them as variations.
- Comparing only purchase price and ignoring water, electricity, and the after-warranty CMC price, which over 10 years can exceed the machine cost.
- Not asking the bidder to state full-load cycle time including drying, so a cheap machine with half the daily throughput wins.