ISO 3533:2021 PDF

Name: ISO 3533:2021 — Sex toys — Design and safety requirements for products in direct contact with genitalia, the anus, or both
SKU: ISO 3533:2021
Price: 25 EUR
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Sex toys — Design and safety requirements for products in direct contact with genitalia, the anus, or both

Название (английский):

ISO 3533:2021

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 16
Дата публикации:: 24 сентября 2021 г.
Издание:: ISO IS 3533 edition 1 version 1
ICS:: 97.170

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Описание (английский):

This document specifies safety and user information requirements relating to the materials and design for manufactured products intended for sexual use. This document covers only manufactured 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, cosmetics or assistive products for example lubricants, massage oil.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 3533:2021 - "Sex toys - Design and safety requirements for products in direct contact with genitalia, the anus, or both" is an international standard that specifies safety, material and user‑information requirements for manufactured sexual products intended to touch genitalia and/or the anus. It focuses on reducing injury risk through design, material selection, risk management and clear user information, and excludes products primarily classified as medical devices, cosmetics or assistive products (for example, lubricants).

Key topics and technical requirements

Risk management: Manufacturers must implement a documented risk analysis process across the product lifecycle, including risk assessment, documentation, periodic review and post‑market surveillance. (Annex A offers guidance.)

Design requirements: Products must be designed for their intended use to minimize mechanical hazards, retention, sharp edges, protrusions and other foreseeable misuse. Special provisions apply for anal‑use products to reduce risk of retention; anatomical guidance is provided (Annex B).

Mechanical safety: Prevention of retention, safe moving/removable parts, and prevention of sharp edges are required. Design features must be tested and documented.

Vibration and electrical safety: Requirements cover vibration hazards and electrical stimulation, with attention to safe operation and user exposure.

Wireless products: Specific design considerations for wireless remote‑controlled devices (safety, control loss, interference).

Materials and biocompatibility: Material safety, biocompatibility assessment, cleaning and maintenance instructions are required; Annex C provides guidance for creating a Restricted Substance List.

User information and labeling: Clear instructions, warnings, packaging and additional user information must be provided to support safe and intended use.

Practical applications

Product design and development: Use ISO 3533:2021 to inform shape, size, materials, and safety features to reduce injury and retention risks.

Compliance and quality systems: Integrate the standard into quality management and product safety documentation, including risk assessments and post‑market monitoring.

Testing and documentation: Define test plans for mechanical safety, electrical safety, vibration, and material biocompatibility; document results and design controls.

Packaging and user instructions: Ensure labeling, warnings and cleaning/maintenance instructions meet the standard’s content requirements.

Related standards

ISO 14971 (risk management principles)

ISO 7000 / ISO 7010 (graphical symbols and safety signs)

ISO 8124‑1 and ISO 10377 referenced for terminology and consumer safety guidance

Keywords: ISO 3533:2021, sex toys standard, design and safety, risk assessment, material safety, biocompatibility, post‑market surveillance, anal use, retention prevention.

ISO 3533:2021 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards

Технические детали

BS/AAMI 34971:2023

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

PD 6578:1995

Guide to British, European and international graphical symbols, for use on equipment, for safety and fire saf…

ISO 7010:2019/Amd 8:2024

Graphical symbols — Safety colours and safety signs — Registered safety signs — Amendment 8

ISO 8124-1:2018/Amd 1:2020

Safety of toys — Part 1: Safety aspects related to mechanical and physical properties — Amendment 1: Flying t…

ISO 10377:2013

Consumer product safety — Guidelines for suppliers