The legal framework around medical equipment is a vast territory. With ISO standards, EU regulations and local recommendations, it is easy to feel confused about what you should look for when buying, commissioning or servicing a piece of equipment in the CSSD. To save you some precious time, we created a document that lists all the equipment you find in the sterile service with the main directives, standards and regulations applicable. Whether you need all standards in one place or looking for an equipment list for training purposes, we have you covered:

>>Download the full CSSD equipment list + standards & regulations pdf<<

Below is a text version of the document:

CSSD equipment list in the cleaning area (soiled zone)

Workbenches

Usually made from stainless steel, workbenches are not considered as Medical Devices. However, they need to follow HSE recommendations in terms of ergonomics and material. Furniture needs to be made from “robust material”, have an easily cleanable surface and be of adequate size.

Manufacturing regulations & standards

• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 1. Suitability of decontamination facilities

Servicing regulations & standards

• No standards or regulations and it is also not required to have preventive maintenance. However, furniture needs to be maintained in “good condition” (see HSE guideline above) and safety checks can be performed in line with the manufacturer’s recommendations

Medical decontamination sinks

Medical decontamination sinks are used for pre-cleaning medical instruments and devices. This is a manual process where the operator uses different types of brushes and immerses the instruments in a cleaning solution. Sinks can have one, two or three bays and be static or height adjustable for the comfort of operators. They are not considered as medical devices but as part of the building, thus some UK standards are applicable.

Manufacturing regulations & standards

• UK Health Technical Memorandum – (HTM 04-01) Safe water in healthcare premises
• WRAS approved – The Water Regulations Approval Scheme is an independent UK certification body for plumbing products and materials

Servicing regulations & standards

• No standards or regulations and it is also not required to have preventive maintenance. However, like furniture, they need to be maintained in “good condition” (see HSE recommendations) and safety checks can be performed in line with the manufacturer’s recommendations

Ultrasonic bath cleaners

An ultrasonic bath use wave of high-frequency sounds inducing Cavitation (microscopic air bubbles) to force the release of dirt and contaminants throughout the full surface of an instrument. It is a pre-treatment process that can be used for instruments with cavities that are harder to reach manually or as advised by the manufacturer. As per HSE recommendations, ultrasonic cleaners should have an interlocked lid and automatic filling and draining.

Manufacturing regulations & standards

• Directive 93/42/EEC – Medical Device Directive (and amendment 2007/47/EC) or Regulation EU 2017/745 – Medical Device regulation
• Directive 2014/30/EU – Electromagnetic Compatibility Directive
• Directive 2014/35/EU – Low Voltage Directive
• Standard EN ISO 15883 Part 1: 2006/Amd 1:2014 Washer-Disinfectors – Part 1: General Requirements, terms and definitions and tests – Amendment 1
• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 2. Decontamination equipment

Servicing regulations & standards

• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 3 Recommended Practice – 13. Cleaning (including pre-cleaning) – Table 13.3

Ultrasonic washers

Ultrasonic washers use the same technology as ultrasonic baths, with added cycle phases. It is also a pre-treating process on a “soak and flush” basis. Instruments are loaded in trays and the machine will submerge the load with water during the ultrasonic cleaning phase. The cycles vary depending on the manufacturer, but it will usually include the injection of chemicals, soaking and draining phases. Some have irrigating systems to plug into specific medical devices.

The same regulations and standards apply as per ultrasonic baths detailed above.

Medical washer-disinfectors

Medical washers are designed to clean and disinfect instruments on trays using purified water, chemicals and various irrigation systems. Cycles typically include a pre-washing phase, a couple of washing phases and a drying phase. The technology around water usage, re-cycling and heating depends on the manufacturer. They also vary in size and features such as automatic doors or automatic trolley detection. They need to have a pass-through system where the instruments are loaded on one side and unloaded on the other side. Finally, they need to include an independent process monitoring system also called traceability software.

Manufacturing regulations & standards

• Directive 93/42/EEC – Medical Device Directive (and amendment 2007/47/EC) or Regulation EU 2017/745 – Medical Device regulation
• Directive 2006/42/EC – Machinery Directive
• Directive 2014/30/EU – Electromagnetic Compatibility Directive
• Directive 2014/35/EU – Low Voltage Directive
• Standard IEC EN 61010 – Safety requirements for electrical equipment for measurement, control, and laboratory use
• Standard IEC 60204-1:2016 – Safety of machinery – Electrical equipment of machines
• Standard EN 61326-1:2013 – Electrical equipment for measurement, control, and laboratory use
• Standard ISO 13485:2016 – Medical devices – Quality management systems
• Standard EN 15883 Part 1: 2006/Amd 1:2014 – Washer-Disinfectors – Part 1: General Requirements, terms and definitions and tests – Amendment 1
• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 2. Decontamination equipment

Servicing regulations & standards

• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 –Part 3 Recommended Practice – 13. Cleaning (including pre-cleaning) – Table 13.2
• Standard IS EN 15883 Part 2: 2009: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware etc

Drying cabinets

When it is not possible to have a pass-through door system for the washer-disinfector, a drying cabinet can be used. They are used to dry and transfer the instrument trays to the next room to be packed for sterilisation. Drying cabinets are not considered as medical devices however the HSE details recommendations in terms of temperature and the requirement to have air circulating mechanically throughout the cabinet to ensure everything is dried uniformly. It is also mandatory to have interlocked doors.

Manufacturing regulations & standards

• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 2. Decontamination equipment

Servicing regulations & standards

• Planned preventative maintenance in line with the manufacturer’s recommendations

Hospital cart washers

Cart washers are similar to medical washer-disinfectors. They are mainly used for larger and non-critical items such as containers or shoes. They also have a pass-through door system.

The same regulations and standards apply as per medical washer-disinfectors.

Basket and containers

Medical baskets and containers are used to hold medical instruments and devices. There are used throughout the decontamination and sterilisation process. In the sterilisation room, baskets containing disinfected instruments are wrapped with medical paper – using a specific technique – before going through the steam steriliser.

Manufacturing regulations & standards

• Directive 93/42/EEC – Medical Device Directive (and amendment 2007/47/EC) or Regulation EU 2017/745 – Medical Device regulation
• Standard ISO 13485:2016 – Medical devices – Quality management systems

Servicing regulations & standards

• No standards and regulations for test and validation. Maintenance in line with the manufacturer’s recommendations

Pass-through hatches

Also called transfer hatches, they are used to pass material from the clean room to the soiled room or outside the decontamination department. They are designed to leave the air from the clean room to populate the hatch (the clean room is normally at higher pressure). They use an interlocking door system to ensure the seal between the soiled rooms and the clean room.

Manufacturing regulations & standards

• Pass-through hatches are not considered as medical devices and are usually operated manually.

Servicing regulations & standards

• No standards or regulations and it is also not required to have preventive maintenance. However, like furniture, they need to be maintained in ‘good condition’ (see HSE recommendations) and safety checks can be performed in line with the manufacturer’s recommendations

CSSD equipment list in the sterilisation area (clean zone)

Packing tables

Packing tables are used for operators to handle disinfected medical instruments. They are used for checking the instrument and packing them to be loaded in the sterilisers (usually in baskets wrapped with medical paper). They come with various accessories and are height adjustable. Like workbenches, packing tables are not considered as medical devices. General best practices regarding health and safety, ergonomics and material are recommended by the HSE.

Manufacturing regulations & standards

• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 1. Suitability of decontamination facilities

Servicing regulations & standards

• No standards or regulations and it is also not required to have preventive maintenance. However, they need to be maintained in “good condition” and safety checks can be performed in line with the manufacturer’s recommendations

Heat sealers

To prepare for sterilisation, instruments can be placed in medical pouches or reels. These require to be sealed through a rotary heat sealer machine.

Manufacturing regulations & standards

• Standard ISO 11607-2:2019 – Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
• Standard EN 868-5:2018 – Packaging for terminally sterilized medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods
• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 2. Decontamination equipment

Servicing regulations & standards

• Standard ISO 11607-2:2019 and Standard EN 868-5:2018 above also cover servicing
• Planned preventative maintenance in line with the manufacturer’s recommendations

Medical steam steriliser

Also called Porous Load Autoclaves, these machines use a combination of high temperature and a saturated steam atmosphere to sterilise medical instruments and devices. A vacuum pump removes all the air from the chamber before hot steam is injected, forced to fill every space. The cycle program and length vary depending on the machine however the sterilisation hold period recommended by the HSE is at 134-137ºC for not less than 3 minutes or 121-124ºC for not less than 15 minutes. They need to have a pass-through door system and an independent process monitoring system (traceability software). Like medical washers, there is a large range of optional functionalities available depending on the manufacturer. Examples of options are automatic trolley recognition, automatic doors and vacuum pump technology.

Manufacturing regulations & standards

• Directive 93/42/EEC – Medical Device Directive (and amendment 2007/47/EC) or Regulation EU 2017/745 – Medical Device regulation
• Directive 2014/68/EU – Pressure Equipment Directive
• Directive 2006/42/EC – Machinery Directive
• Directive 2014/30/EU – Electromagnetic Compatibility Directive
• Directive 2014/35/EU – Low Voltage Directive
• Standard EN 13445 – Unfired Pressure Vessels Standard
• Standard IEC EN 61010 – Safety requirements for electrical equipment for measurement, control, and laboratory use
• Standard IEC 60204-1:2016 – Safety of machinery – Electrical equipment of machines
• Standard EN 61326-1:2013 – Electrical equipment for measurement, control, and laboratory use
• Standard EN 285:2016 – Sterilisation – Steam sterilizers – Large sterilisers
• Standard IS EN 17665 Part 2:2009 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1
• Standard ISO 13485:2016 – Medical devices — Quality management systems
• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 2. Decontamination equipment

Servicing regulations & standards

• Standard IS EN 17665 Part 1: 2006 Sterilization Of Health Care Products – Moist Heat – Part 1 Requirements For The Development Validation And Routine Control Of A Sterilization Process For Medical Devices (IS EN 17665-1:2006)
• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 3 Recommended Practices – Table 19.3 and 19.4

CSSD equipment list in the cooling room (sterile zone)

Shelving and storages

These are used to store sterilised products, and in other areas for PPEs, chemicals or other materials. Like workbenches, shelving and storage are not under any medical device regulations or standards. In addition to the same recommendation for workbenches, the HSE recommend to be made of non-shedding material and should not be more than 2m high.

• HSE Standards and Recommended Practices for Central Decontamination Units – QPSD-D-003-2.1 V2.1 – Part 2 Standards – 1. Suitability of decontamination facilities

We hope you found this list useful! If you haven’t downloaded the full CSSD equipment list yet, you can find it here. Don’t know the difference between standard and regulation? Or struggle to understand the regulations’ acronym? Check our guide to the Medical Device regulatory framework in the CSSD.

At Manepa we have 50 years of experience in supplying commissioning, validating and servicing medical equipment for CSSD. Our 10 accredited engineers are scattered all over Ireland, trained by an independent body, and accredited by City & Guild. Have a question regarding CSSD equipment? Just get in touch, our team will be happy to help.