EN ISO 20342-1 Aids to Tissue Integrity in the Lying Down - Part 1: General Requirements

The “EN ISO 20342-1 Assistive devices for tissue integrity in supine position - Part 1: General requirements” standard, which is based on a European standard and subsequently published by the International Organization for Standardization (ISO), describes the general requirements and relevant test methods for assistive devices for tissue integrity in supine positions in different application settings such as hospitals, home care, and institutions.

This standard applies to the safety of tissue integrity aids intended to remain in place in the supine position and to prevent or treat pressure injuries. This standard covers a variety of supine support surfaces intended for use in conjunction with an appropriate support platform or as an integrated system. This standard also covers aids intended primarily for tissue integrity to change the supine position and aids to maintain the supine position.

This standard does not apply to reclining support surfaces used with incubators. This standard addresses the combination of a full body support surface and an adjustable mattress support platform. It also specifies safety and performance test methods to provide protection against injury to the user.

This standard defines the requirements and test methods for ancillary products for tissue integrity within the following classifications of the ISO 9999 standard:

• Ancillary products that support tissue integrity while lying down include, but are not limited to:
  • Mattresses and mattress toppers for pressure sore prevention
  • Mattress covers for pressure sore prevention mattresses
• Gliding and turning aids include, but are not limited to, devices that allow a person to change position or orientation using gliding or turning techniques. The only products included are those designed for use in a recumbent position and that remain in place as part of the recumbent support surface. These include:
  • Sliding products that slide in one direction and lock in the other direction
  • Sheets and pads made of low-friction flexible materials
  • Fabric sold by the metre, cut as required for repositioning use
  • Motorized rotation product

Sliding boards are excluded unless the product is intended to be left in place.

• Positioning pads, positioning cushions and positioning systems, including but not limited to:
  • Leg positioners
  • Arm positioners and
  • Multi-purpose body positioners
• Bedding, including but not limited to linens.

For the purposes of this standard, the following terms and definitions apply:

• Application setting 4 refers to care provided in a home setting where tissue integrity aids are used to alleviate or compensate for an injury, disability or illness. This excludes use in all other application settings, e.g., nursing homes, rehabilitation and geriatric facilities, when a tissue integrity aid is intended solely for application setting 4.
• Applied part refers to the part of a medical system that comes into physical contact with the user of these products or with the function of a medical system in the normal use of auxiliary products for tissue integrity.
• Auxiliary product means a tool, equipment or technical system intended by the manufacturer to be used for the prevention, treatment or mitigation or compensation of deterioration.
• A tissue integrity aid refers to a surface designed to protect body tissue. It is designed to interface with the body in a supine or adjusted position.
• Body mass index is a value derived from an individual's mass (weight in kilograms) and height (in meters). It is obtained by dividing body mass by the square of body length.
• Clinical evaluation refers to the assessment and analysis of clinical data pertaining to a medical device when used in accordance with the manufacturer's intended use. It may include a compilation of clinical data, any scientific literature and the results of any clinical investigations, taking into account any relevant harmonized standards.
• Clinical research refers to a systematic study in human subjects conducted to verify the safety and performance of a specific medical device under the manufacturer's intended conditions of use.
• Detachable part refers to a part that is designed to be removed or disconnected without damaging the part or the whole.
• Disability refers to impairments, activity limitations, and participation restrictions. It refers to the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (environmental and personal factors).
• The expected service life refers to the period of time specified by the manufacturer during which the tissue integrity aid is expected to remain safe for use (i.e. maintain basic safety and claimed performance). Maintenance may be required during the expected service life.

This standard describes the minimum requirements that must be met by manufacturers or distributors of a tissue integrity aid product to ensure safety and compliance with applicable standards, and the necessary tissue integrity aid product development activities.

Further guidance on the development, manufacture and management of medical devices is provided in the ISO 13485 standard. A tissue integrity aid is a medical device and, like other medical devices, must be designed, manufactured and promoted for appropriate use. There are many application environments, types of caregivers and human sizes, shapes and abilities. These need to be taken into account when developing, manufacturing and promoting a tissue integrity aid. An example of the methodology for developing, manufacturing and promoting a tissue integrity aid is included in the standard annex (Annex A1).

As part of this standard, manufacturers must develop an intended use statement for tissue integrity adjuvant products. This should include the application setting, appropriate patient population (based on patient risk), and general medical claims (such as claims to reduce the risk of pressure injuries). The intended use should be appropriately considered throughout the development of a tissue integrity adjuvant product and should be considered during risk assessment.

Our organization has a strong staff that closely follows the developments in science and technology in the world and constantly improves itself. Among the numerous test, measurement, analysis and evaluation studies provided for businesses in various sectors, there are also test services in accordance with the standard “EN ISO 20342-1 Auxiliary products for tissue integrity in the lying position - Part 1: General requirements”.