What is ISO 203421 - Assistive products for tissue integrity about?
ISO 20342 discusses assistive products for tissue integrity when lying down. ISO 20342-1 lays out general requirements and related test methods that are relevant to assistive products for tissue integrity (APTI) in the lying position in different application environments such as hospitals, home care, and institutions. ISO 20342-1 applies to the safety of APTI, which are intended to remain in situ during periods of lying, and to prevent and/or treat pressure injuries.
ISO 20342-1 covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform or integrated system.
ISO 20342-1 also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position.
ISO 20342-1 addresses the combination of a full-body support surface and an adjustable mattress support platform. It also covers safety and performance test methods to ensure protection against injuries to the user.
ISO 20342-1 specifies requirements and test methods for APTI within the following classifications of ISO 9999:2016:
Note: ISO 20342-1 does not apply to lying support surfaces used in combination with incubators.
Who is ISO 20342-1 - Assistive products for tissue integrity for?
ISO 20342-1 on assistive products for tissue integrity when lying down is useful for:
- Assistive products manufacturers
- Test centres for assistive products
- Regulatory authorities
Why should you use ISO 20342-1 - Assistive products for tissue integrity?
Assistive product is intended by the manufacturer to be used for the prevention, treatment, or alleviation of or compensation for impairment. Assistive products for tissue integrity (APTI) play a very important role in the prevention and treatment of pressure injuries. Another important role in the prevention and treatment of pressure injury is the clinical practice and the clinical evaluation.
ISO 20342-1 guideline helps you with general requirements and safety on intended use, APTI risk management, APTI usability, design controls, clinical evaluation, foreseeable misuse, test conditions, lifting, and carrying means for assistive products for tissue integrity when lying down.
ISO 20342-1 also provides guidance on safety requirements, flammability, mechanical safety, the safety of electrical equipment, biocompatibility, and contamination for assistive products for tissue integrity when lying down. This helps in improving the quality and safety of assistive products for tissue integrity when lying down and ensures patient’s health and safety.
