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ISO/NP Sex toys — Design and safety requirements for products in direct contact with genitalia, the anus, or both

Scope

This document specifies safety and user information requirements relating to the materials and design for products intended for sexual use.

This document covers only products that are intended to come in direct contact with genitals and/or the anus.

This document is not primarily intended for products classified as medical devices or assistive products.

Purpose

In a study published 2018 [1] Swedish researchers could see an increase in incidences of objects used for sexual pleasure retained in anus/rectum leading to severe surgical procedures. This finding was also supported by a systematic review based on available data which showed that the cases where patients require surgical extractions has increased across the world. This due the fact that objects used in the anus/rectum where not possible to remove the “natural way”. 40 percent of these objects where noted to be sex toys. However, the authors also suggested that the true figure of sex toy retention is likely even higher than the study suggests, given reluctance to seek care for a potentially embarrassing condition.

Sex toys are being produced, designed and sold globally, it is a global market with consumers across the globe. As there currently are no international standards or regulations specifically for these types of products, each manufacturer and retailer are free to make up their own test method and quality systems, at times based on standards and rules from documents with similar material or safety perspective, but not specific to the intended use of the actual product.

This proposed global standard intended for manufacturers, retailers, medical providers and consumers hopes to reduce incidences where sex toys do to misuse, or accidents cause unnecessary pain for users, save money for the health care sector and enables companies to show conformity. This by stating clear requirements for risk assessment, sufficient user information, outlining safety and quality requirements and providing recommended design considerations.

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Please email further comments to: debbie.stead@bsigroup.com

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