ISO 3533:2021
Sex toys — Design and safety requirements for products in direct contact with genitalia, the anus, or both
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management
4.1 General
4.2 Risk analysis process
4.3 Risk assessment
4.4 Post-market control
5 Design requirements
5.1 General
5.1.1 Anal use products
5.2 Mechanical hazards
5.2.1 Prevention of retention
5.2.2 Products for genital enclosure
5.2.3 Moving and removable parts
5.3 Vibration
5.4 Electrical safety
5.4.1 Electrical stimulation
5.5 Surface temperature
5.6 Design requirement for wireless remote-controlled products
5.7 Surfaces, corners, edges, and protruding parts
6 Materials
6.1 General
6.2 Material safety
6.3 Biocompatibility
6.4 Cleaning and maintenance
7 User information
7.1 General
7.2 Content of user information on product
7.3 Packaging
7.4 Additional user information
Annex A (informative) Guidance on risk management
Annex B (informative) Design considerations based on anatomy
Annex C (informative) Guidance for creating a Restricted Substance List
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management
4.1 General
4.2 Risk analysis process
4.3 Risk assessment
4.4 Post-market control
5 Design requirements
5.1 General
5.1.1 Anal use products
5.2 Mechanical hazards
5.2.1 Prevention of retention
5.2.2 Products for genital enclosure
5.2.3 Moving and removable parts
5.3 Vibration
5.4 Electrical safety
5.4.1 Electrical stimulation
5.5 Surface temperature
5.6 Design requirement for wireless remote-controlled products
5.7 Surfaces, corners, edges, and protruding parts
6 Materials
6.1 General
6.2 Material safety
6.3 Biocompatibility
6.4 Cleaning and maintenance
7 User information
7.1 General
7.2 Content of user information on product
7.3 Packaging
7.4 Additional user information
Annex A (informative) Guidance on risk management
Annex B (informative) Design considerations based on anatomy
Annex C (informative) Guidance for creating a Restricted Substance List
Bibliography