Guidance to the mattress and related devices’ General Requirements standard: BS EN ISO 20342-1:2022

Last Updated on 21/02/2024 by Sarah Sarsby

Written by experts from the BHTA Beds and Support Surfaces and Pressure Care and Seating Sections.

Overview

The ISO 20342 series of standards covers various aspects of safety, performance, and technical information relating to mattresses and related products, products described in the standards as “Assistive Products for Tissue Integrity” or “APTIs”. Part 1 of the series covers General Requirements, and these are applicable to all APTIs. The information set out within the general requirements standard is intended to help ensure the safety of users.

The devices covered by this standard include all pressure redistributing mattresses and overlays manufactured using a range of materials including foam, gel, air, and foam in combination with air (i.e. hybrid mattresses). Products within the scope of this standard also include all reactive (non-powered) and active (powered) mattresses and overlays. This standard does NOT include wheelchair cushions.

Aspects relating directly towards the clinical efficacy of a product (and therefore the safety-related properties in prevention or management of pressure injuries, for example) are not addressed in this standard, but are topics covered by tests prescribed in other parts of the ISO 20342 series.

The aim of this article is to give the reader a feel as to why they should be aware of the standard’s content and provide an overview of what the standard covers in depth, and therefore its importance in the design, selection, and use of an APTI.

Why is BS EN ISO 20342-1 so important as a safety standard?

BS EN ISO 20342-1 is the first mattress and related device international safety standard. It sets the minimum threshold a device should reach in order to protect the safety of users.

What aspects of device safety does the standard cover?

BS EN ISO 20342-1 covers the key safety elements from an APTI-specific standpoint. These include management of potential hazards and addresses specific areas of mechanical, electrical, and materials safety. Table 1 contains a summary of the areas covered by the standard.

Table 1. List of safety Clauses and Sub-clauses and Annexes included in BS EN ISO 20342-1

Clause	Content
4. General requirements and safety	4.1 General; 4.2 Intended use; 4.3 Risk management; 4.4 Usability; 4.5 Design controls; 4.6 Clinical evaluation; 4.7 Foreseeable misuse; 4.8 Test conditions; 4.9 Lifting and carrying means
5. Safety requirements	5.1 Information supplied by the manufacturer; 5.2 APTI that can be dismantled; 5.3 Resistance to corrosion; 5.4 Noise and vibration; 5.5 Sound audible acoustic energy; 5.6 Default indicators; 5.7 Feedback
6. Flammability	6.1 General; 6.2 Flammability; 6.3 Moulded parts used as enclosures for electrical equipment
7. Mechanical safety	7.1 Prevention of traps; 7.2 Moving and folding parts; 7.3 V-shaped openings; 7.4 Surfaces, corners, edges and protruding parts; 7.5 Folding and adjusting mechanisms; 7.6 Instability hazard; 7.7 Temperature of parts in contact with skin; Ergonomic principles; Additional considerations
8. Safety of electrical equipment	8.1 General; 8.2 Electromagnetic compatibility; 8.3 Liquid ingress; 8.4 Interruption of power supply; 8.5 Hold to run activation; 8.6 Emergency stop functions
9. Biocompatibility	9.1 Biocompatibility and toxicity; 9.2 Animal tissue
10. Contamination	10.1 Liquid ingress; 10.2 Cleaning and disinfection; 10.3 Cross infection and microbial contamination
Annex A. General Information	A.1 General; A.2 Design controls; A.3 Packaging; A.4 Noise and vibration; A.5 Flammability; A.6 Ergonomic principles; A.7 (EMC) immunity; A.8 Cleaning and disinfection; A.9 Moisture vapour permeability/microclimate management
Annex B. Environmental and consumer related guidance	Covers Hazardous Substances in an APTI. B.1 General; B.2 All materials; B.3 Textiles; B.4 Plastic materials; B.5 Metals; B.6 Wooden parts
Annex C. Periodic inspection

What is involved in the requirements covered by the Clauses listed in Table 1?

1. Clause 4 gives the parameters as to which devices will fall under the ISO 20342 series of standards and sets the scene around risk assessment and management as might be relevant to a device. The one quantified item in this clause is 4.9 that covers the means for manual handling devices with a mass more than 20kg.
2. Clause 5.1 gives an extensive list of what a manufacturer should provide in their documentation, including the pre-sales literature, instructions for use, servicing, and labelling. Where the manufacture considers there to be specific potential risks, these need to be covered by specific warnings in the literature and appropriate labelling of the devices.
   Further safety and functionality risks arise around devices that can be dismantled, and these are considered in Clause 5.2. Resistance to corrosion is in 5.3, while Noise and Vibration aspects are in 5.4. and 5.5.
   Alarm conditions and their indications are the subject of 5.6 and 5.7, where the risk of harm to the patient from a failure and the urgency of a related alarm are considered.
3. Risk from fire is a major safety concern for the user of an APTI, and the general approach to this risk is handled by Clause 6. (Note that specific resistance to flammability tests for APTIs are being developed and will be published in ISO 20342-9.)
4. Many APTIs have mechanical parts, and the safety around the design of these is covered in Clause 7. Finger, foot, or head traps arising from both static set-ups and from moving parts are addressed across the Sub-clauses of Clause 7. Other specific mechanical risks are also covered, such as the safety of any protruding parts, instability of potential set-ups, risks of causing burns if temperatures of components made from different materials get too hot, blockage of air tubes, etc.
5. If there are electrically operated components of an APTI, these come with attendant risks. Clause 8 covers the mitigation of the direct risks and calls up the relevant IEC standards that apply. Indirect risks such as interruption of electrical supply and their consequences are addressed, as are the appropriate IP ratings to protect against fluid ingress around electrical components.
6. In Clause 9, Biocompatibility is covered by calling up already-existing ISO standards in this area.
7. There is always a risk of contamination of an APTI from bodily fluids of users and of microbial cross-infection. The design of the products to minimise the risks of ingress of the contaminants, and to facilitate any routine cleaning and decontamination, is the subject of Clause 10. (Materials characteristics and test methods are the subject of ISO 20342 parts 5 and 10.)
8. Further aspects for consideration around some of the Sub-clauses summarised above are amplified in Annex A. Guidance around forces to operate levers is given special attention under the Ergonomic Principles heading.
9. Annex B looks at the environmental and human health risks arising from a variety of classes of chemicals that might be used in the production of an APTI, and which of these chemicals should be avoided.
10. Annex C provides guidance around the processes that should be followed to cover appropriate periodic inspection of a device.

How can the BS EN ISO 20342-1 standard help healthcare providers?

This standard clearly sets out the expected safety requirements for all mattress surface devices, irrespective of which medical device classification they fall into. To deliver safe, effective, harm-free care to patients, it is not unreasonable to assume the use of devices which meet the required level of safety and do not inadvertently introduce any additional risks to users.

With pressure ulcers recognised as a preventable harm and pressure ulcer incidence metrics typically reported at board meetings as a key indicator or care quality, it is prudent for providers to use products that meet the required levels of safety.

What does BS EN ISO 20342-1 mean to clinicians/prescribers in a mattress tendering process?

Clinicians will benefit from clear statements around the intended use, intended users, and any device claims around performance and safety, including minimum and maximum user weight on the device.

Furthermore, supporting documents, such as the clinical evaluation and instructions for use, will give additional information about the suitability of the device for local patients/residents. Requesting relevant evidence as part of a tender process will help ensure that claims of device performance are substantiated with appropriate levels of evidence and supporting documentation. This can be particularly helpful when looking to substantiate claims for self-certified, Class I medical devices, which are otherwise externally-unregulated devices.

Where manufacturers’ products align with this standard, it demonstrates that the manufacturers are seeking to attain minimum levels of device safety and that their claims around device performance can be supported by suitable data and evidence, thereby giving clinicians peace of mind when prescribing the products for patients.

Should it be a concern if manufacturers’ products are non-compliant with BS EN ISO 20342-1:2022?

Medical device manufacturers typically strive to deliver the safest, most effective products to the market. Since elements of BS EN ISO 20342-1 will apply to every APTI sold in the UK it would be a concern to understand why a manufacturer would not want their products to comply with this standard.

How can healthcare providers influence uptake of these standards?

Healthcare providers can help encourage uptake of these standards by listing compliance as a prerequisite on mattress tender submissions. If manufacturers need to comply with specific elements of the ISO 20342 series of standards (e.g. Part 1, General Requirements) to be considered for the tender, this would greatly encourage this area of the medical device industry to meet the requirements for BS EN ISO 20342-1:2002.

Where can I get more information on BS EN ISO 20342-1:2022?

BS EN ISO 20342-1:2022 – TC | 31 Aug 2022 | BSI Knowledge (bsigroup.com)

For a broader background to the ISO 20342 series of APTI standards, see the BHTA article: ‘New standards for testing mattresses and related products – An Introduction’