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.
Sisällysluettelo
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
5.2 Mechanical hazards
5.3 Vibration
5.4 Electrical safety
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 Guidance on risk management (informative)
Annex B Design considerations based on anatomy (informative)
Annex C Guidance for creating a Restricted Substance List (informative)
ISO 7000 Graphical symbols for use on equipment — Registered symbols
ISO 7010 Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 7000 Graphical symbols for use on equipment — Registered symbols
ISO 7010 Graphical symbols — Safety colours and safety signs — Registered safety signs