HOW ELEGANT ENCLOSURES UNDERLINE THE HIGH QUALITY OF YOUR MEDICAL TECHNOLOGY

Medical electronics must comply with strict international standards. The unique demands of this market make it important to partner with a specialist enclosure manufacturer that has extensive experience of the sector.

Plastic enclosures that house and protect medical electronics must be robust, ergonomic and well designed. They must perform well and look elegant – reflecting the high-quality technology they house.

OKW has a long history of designing and developing standard, customisable enclosures for medical electronics. We created the proven MEDITEC specifically for desktop, portable and wall-mount applications in healthcare and laboratories.

View 59 examples of customized enclosures for medical electronics >>

INTERNATIONAL STANDARDS FOR MEDICAL DEVICES

ISO 10993 is a global standard that confirms medical devices are biocompatible. It ensures that the materials used are not toxic and do not cause adverse or harmful reactions such as irritation.

Testing involves a risk-based approach. This takes into account the intended application and also how long the device will be in contact with the human body. Devices are tested for:

• cytotoxicity – to confirm that cells are not harmed
• sensitisation – to ensure there are no allergic reactions
• haemocompatibility – for devices that come into in contact with blood.

IEC 60601 is a widely recognised international standard that covers the basic safety and essential performance of medical electronics. Important aspects include electrical and mechanical safety, electromagnetic compatibility (EMC) and the environment in which the device will be used.

Again, a risk-based approach is used for testing. Tests are aligned closely with ISO 14971, the standard for risk management in medical devices. Compliance with ISO 60601 is essential for UKCA marking in the UK, CE marking in the EU, and FDA approval in the USA.

ISO 14971 sets out a structured process to quantify and manage risks in the development of medical devices. This includes the identification, estimation, evaluation, control and benefit analysis of risks.

Every medical device must have a formal risk management plan that defines the activities, responsibilities and acceptance criteria for managing risks throughout its operational life. Device lifecycles are critical, including design/development, production, use and post-marketing surveillance (such as monitoring incident reports and feedback from users).

ISO 13485 is a management quality standard that is often aligned with ISO 14971. It requires the implementation of comprehensive design and development processes (design planning, inputs and outputs, reviews/verifications and validation) along with documentation and traceability, production and process controls, correction and preventative actions (CAPA), customer and regulatory feedback, personnel competence and training.

ENCLOSURE ROBUSTNESS: SPECIFYING THE RIGHT PLASTIC

Healthcare can be a challenging environment for electronics. Devices may not be subjected to the rigours of factory life. But the average hospital can be much tougher on devices than perhaps an office or a domestic setting.

Medical devices may be used around the clock by multiple operators with differing levels of training. This relentless use means that devices must withstand a lot of punishment. And they must continue to look good while doing so: nobody wants to be treated with equipment that appears worn out.

In the past, Acrylonitrile Butadiene Styrene (ABS) was the go-to plastic for medical device enclosures because it is strong, durable and looks good. ABS is resistant to impact – and it can stand repeated use without cracking, warping or showing signs of abrasion.

Despite its strength, ABS is also light – minimizing the weight of handheld devices without compromising their structural integrity. It is also resistant to many common cleaning agents, disinfectants and chemical sterilization processes.

But ABS has one big weakness: it is vulnerable to degradation or discoloration by UV light. For this reason, more enclosures are being molded from Acrylonitrile Styrene Acrylate (ASA) – even for devices that will be used indoors.

Just like ABS, UV-stable ASA is strong (even in colder temperatures) and highly resistant to chemicals. But it has better color fastness and surface gloss retention than ABS. This longer-lasting shine matters in healthcare and social care environments because it makes cleaning easier.

INGRESS PROTECTION: WHICH IS THE RIGHT LEVEL OF WATER RESISTANCE?

The differing levels of water resistance quantified by IP ratings (or NEMA ratings in the USA) can be confusing because a higher number is not always better – merely different. The first digit in an IP rating indicates protection against dust ingress, the second shows protection against water ingress. Key ratings are IP 65, IP 66 and IP 67 – but some of the higher IP 5X ratings may also be worth thinking about, depending on your specific medical application.

View our guide to IP ratings >>

SPECIFY TAMPERPROOF ENCLOSURES

This is vital for medical electronics: the fixings must be tamperproof. Look for Torx fixing screws. However, it’s not a dealbreaker if they’re not fitted as standard because they can be substituted in preference to the existing screws.

Torx screws should be mentioned as a technical benefit in the product information. Another quick clue is to see whether the accessories for your preferred model include a Torx screwdriver.

Alternatively, specify an enclosure that has no fixing screws. Some models feature snap-together construction. They include CONNECT for wired electronics and also SMART-PANEL for small touch screens and keypads. Discreet, attractive SMART-PANEL fits standard flush-mount or cavity wall boxes. It can be easily reopened using a set of special plastics tools (accessory).

Meanwhile, SMART-BOX (IP 66) can be specified with security plugs (accessories). These enclosures also offer the added benefit of lid-closed installation to protect the seal and electronics during fitting.

WEARABLE ENCLOSURES FOR MONITORING, GEOLOCATION, ON CALL, EMERGENCIES

Medical and wellness applications have played an important role in driving demand for wearable electronics. Wearable enclosures such as BODY-CASE are used to house sensors that provide continuous monitoring of vital signs or health metrics. This can include monitors for heart rate/ECG, blood pressure, glucose  and temperature.

Wearable housings are also specified for:

• fitness and wellness trackers – measuring steps, sleep patterns and overall health
• drug-delivery systems – insulin pumps, pain management devices and portable infusion systems for chemotherapy and antibiotics
• diagnostics – portable ultrasound devices and respiratory monitors
• medical alert and emergency devices – fall detection, personal emergency response systems and seizure detection
• geolocation/on call – for tracking the location of patients and staff and/or for alerting doctors, nurses and other clinicians.

Enclosure ergonomics are crucial because the device will be worn on the body – possibly in direct contact with the skin – for long periods. The user must not feel any discomfort or awkwardness whatsoever, especially if they are the patient.

View OKW’s wearable enclosures >>

HANDHELD ENCLOSURES FOR MEDICAL ELECTRONICS

Like wearable enclosures, handheld housings raise expectations when it comes to ergonomics. The device must sit comfortably in the hand. Furthermore, if the user is the patient, then they may have grip issues due to injury, disability or infirmity.

Enclosures such as the BLOB range have been designed specifically for this purpose. Their unusual shape is designed to guide users’ fingers instinctively toward the controls – making device use as simple as possible.

Other notable handheld enclosures include MINITEC (for wireless remote personal electronics), STYLE-CASE and SMART-CASE (for remote controls, such as for hospital beds), and CARRYTEC for portable instrumentation.

View OKW’s handheld enclosures >>

DESKTOP/TABLETOP ELECTRONIC ENCLOSURES FOR HEALTHCARE

These are important devices because they can often be at the heart of administrative operations in a hospital or doctor’s surgery – and, as such, they will be used a great deal. Soft contours on the enclosure make operation of the controls more comfortable and give the device a smart, modern look. Our popular EVOTEC enclosures exemplify this.

Will your device require a membrane keypad? In which case, the top will need a large, generous recess to protect it: consider models such as PROTEC, COMTEC or SMART-TERMINAL. Or will the enclosure need to accommodate a customized aluminum front panel? If so, specify a housing from the DESK CASES range.

Will the enclosure need a sloping top? What would be the preferred angle of inclination? 12°, 18°, 20°? If the housing needs to match other devices (such as wall-mounted units) then look for a model with a wall suspension element in its range of accessories. Models such as the multifunctional INTERFACE-TERMINAL offer plenty of options thanks to their modular design.

View OKW’s desktop/keypad enclosures >>

WALL-MOUNT PLASTIC ENCLOSURES FOR MEDICAL ELECTRONICS

This category covers a very broad spectrum of enclosures of all shapes and sizes – making it easy to specify your ideal housing with very little need for customization. We now offer 26 different wall-mount enclosure models.

They include:

• tiny sensor enclosures – such as fast-fit MINI-DATA-BOX (available with/without flanges)
• large and sturdy SOLID-BOX (IK08, IP 66, IP 67)
• slimline NET-BOX for data and communication network nodes
• wedge-shaped SMART-CONTROL for corner-mount devices.

Some wall-mount models double as desktop enclosures. The sloping top presents a keypad at a convenient angle – perfect for access control applications. Some enclosures can be specified with or without a separate terminal compartment that offers lots of room for the wiring.

Consider also whether you need your enclosure to have a hinged lid/cover, a glass panel for a touch screen, or a choice of colour-coded trims to hide the lid and fixing screws. It’s always worth checking the Accessories tab on each range to find out more.

View OKW’s wall-mount enclosures >>

SPECIFY CUSTOMIZED ENCLOSURES FOR MEDICAL ELECTRONICS

Customizing standard plastic enclosures is the smart way to specify a great housing at the right price – especially where low volumes are concerned. OKW now has more standard models than ever, many designed for highly specialist applications (and yet still very versatile). This reduces the amount of customization needed.

New CNC machining and digital printing technology make it possible to transform these off-the-shelf models into fully finished enclosures – even in small batches, making customization more viable for highly specialised medical and laboratory instrumentation.

We carry out all the work in-house to ensure consistently high quality. This makes us accountable for the look and feel of your customized enclosures from beginning to end. It also saves you time, money and administration.

And it’s good for the planet because there’s no need to shuttle the goods between various sub-contract suppliers. They are shipped straight from us to you. They can go directly from your Goods In to your production line for installation of the electronics – speeding up the manufacturing process.

OKW’s customisation services include CNC machining; lacquering (with a new, wider range of color options); printing of legends, logos and graphics; laser marking (for individual/sequential labelling); decor foils in photo quality; special materials (V-0, bespoke colors); RFI/EMI shielding, and installation/assembly of accessories.

Find out more about customization >>

GET EXPERT TECHNICAL ADVICE

Contact OKW for advice on how to specify the best enclosures for your medical electronics. Don’t forget to request a sample of your preferred model.