BS EN ISO 20342-1:2022 Assistive Products for Tissue Integrity When Lying Down - General Requirements

Standard Number: BS EN ISO 20342-1:2022

Pages: 46

Released: 2022-08-05

ISBN: 978 0 539 20108 6

Name: Assistive Products for Tissue Integrity When Lying Down - General Requirements

Status: Standard

Overview

Introducing the BS EN ISO 20342-1:2022, a comprehensive standard that sets the benchmark for assistive products designed to maintain tissue integrity when lying down. This standard is essential for manufacturers, healthcare providers, and regulatory bodies who are committed to ensuring the highest quality and safety in assistive products.

Why This Standard is Essential

Pressure ulcers and other tissue integrity issues are significant concerns for individuals who are bedridden or have limited mobility. The BS EN ISO 20342-1:2022 standard provides detailed guidelines and requirements to ensure that assistive products, such as mattresses and cushions, are designed to minimize the risk of these conditions. By adhering to this standard, manufacturers can produce products that offer optimal support and comfort, thereby enhancing the quality of life for users.

Key Features

• Comprehensive Guidelines: The standard covers a wide range of requirements, including material properties, design specifications, and performance criteria.
• Evidence-Based: Developed based on the latest research and clinical evidence, ensuring that the guidelines are both practical and effective.
• International Recognition: As an ISO standard, it is recognized and respected globally, facilitating international trade and compliance.
• User-Centric Design: Emphasizes the importance of user comfort and safety, ensuring that products meet the needs of those who rely on them.

Who Should Use This Standard?

This standard is invaluable for a wide range of stakeholders, including:

• Manufacturers: Ensure that your products meet the highest standards of quality and safety.
• Healthcare Providers: Select products that are proven to be effective in maintaining tissue integrity.
• Regulatory Bodies: Use this standard as a benchmark for evaluating the safety and efficacy of assistive products.
• Researchers: Reference this standard in studies related to tissue integrity and assistive product design.

Detailed Content

The BS EN ISO 20342-1:2022 standard spans 46 pages and includes detailed sections on:

• Material Requirements: Specifications for the materials used in assistive products, ensuring they are safe, durable, and effective.
• Design Criteria: Guidelines for the design of products to ensure they provide adequate support and comfort.
• Performance Testing: Methods for testing the performance of products to ensure they meet the required standards.
• Labeling and Documentation: Requirements for product labeling and documentation to ensure transparency and traceability.

Benefits of Compliance

Adhering to the BS EN ISO 20342-1:2022 standard offers numerous benefits, including:

• Enhanced Product Quality: Ensure that your products are of the highest quality, providing peace of mind to users and healthcare providers.
• Increased Marketability: Products that comply with international standards are more attractive to buyers and can be marketed globally.
• Regulatory Compliance: Meet the requirements of regulatory bodies, reducing the risk of non-compliance issues.
• Improved User Outcomes: Provide products that effectively maintain tissue integrity, improving the quality of life for users.

Conclusion

The BS EN ISO 20342-1:2022 standard is a vital resource for anyone involved in the design, manufacture, or use of assistive products for tissue integrity. By following the guidelines set out in this standard, you can ensure that your products are safe, effective, and of the highest quality. Whether you are a manufacturer looking to improve your product offerings, a healthcare provider seeking reliable products, or a regulatory body aiming to set high standards, this standard is an essential tool.

Invest in the BS EN ISO 20342-1:2022 standard today and take a significant step towards enhancing the quality and safety of assistive products for tissue integrity.

BS EN ISO 20342-1:2022

This standard BS EN ISO 20342-1:2022 Assistive products for tissue integrity when lying down is classified in these ICS categories:

• 11.180.01 Aids for disabled and handicapped persons in general

This document specifies 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. This document applies to the safety of APTI that are intended to remain in situ during periods of lying, and to prevent and/or treat pressure injuries. This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform (adjustable included) or as a whole integrated system. This document does not apply to medical beds. This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position. This document does not apply to lying support surfaces used in combination with incubators or operating/surgical tables. It also covers safety and performance test methods to ensure protection against injuries to the user. This document 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. This document specifies requirements and test methods for APTI within the following classifications of ISO 9999:2022: 04 33 06 Assistive products for tissue integrity when lying down such as but not limited to —    mattresses and mattress overlays for pressure injury prevention, and —    mattress coverings for pressure injury prevention mattresses. 12 31 03 Assistive products for sliding and turning such as but not limited to the following: Devices for changing position or direction of a person using sliding or turning techniques. The only products included are those intended to be used in a lying position and remain in situ as part of the lying support surface. They are the following: —    sliding products that glide one way and lock the other way; —    sheets and underlays in flexible materials with low friction; —    fabric sold by the metre, cut as required for repositioning use; —    powered turning product; This excludes sliding boards unless the product is intended to be left in situ. 09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to —    leg positioners, —    arm positioners, and —    multipurpose body positioners. 18 12 15 Bedding such as but not limited to —    draw sheets.