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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ISO 3533:2021(en)

	International Standard ISO 3533
Sex toys — Design and safety requirements for products in direct contact with genitalia, the anus, or both Sex toys — Exigences relatives à la conception et à la sécurité des produits destinés à être mis en contact direct avec les organes génitaux, l’anus ou les deux Reference number ISO 3533:2021(en)	First edition 2021-09 © ISO 2021

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ISO 3533:2021(en)

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.

ISO copyright office

CP 401 • Ch. de Blandonnet 8

CH-1214 Vernier, Geneva

Tel. + 41 22 749 01 11

E-mail copyright@iso.org

Website www.iso.org

Published in Switzerland

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ISO 3533:2021(en)

ContentsPage

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

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Project Committee ISO/PC 325, Sex Toys – Design and safety requirements for products in direct contact with genitalia, the anus or both.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

Sex toys are produced, marketed and sold in most countries in the world. These products are in touch with physically sensitive parts of the body. It may be embarrassing for the users to report issues concerning these products. Creating an international standard for sex toys regarding design, materials and user information would help both user, producers and re-sellers to make sure that the sex toys on the market are safe to use and that the user has enough information on how to use them correctly.

This document aims to ensure that the design of sex toys minimizes the risk of injuries to the user for reasonable and foreseeable use, that the materials are safe to use in contact with genitalia, the anus or both, and also that there is sufficient and correct information provided to the user.

The requirements in this document are intended for manufacturers of sex toys. However, all parties in the supply chain may benefit from using this document as guidance.

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ISO 3533:2021(en)

International StandardISO 3533:2021(en)

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

1Scope

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.

2Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 7000, Graphical symbols for use on equipment — Registered symbols

ISO 7010, Graphical symbols — Safety colours and safety signs — Registered safety signs

3Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

—

ISO Online browsing platform: available at https://www.iso.org/obp

—

IEC Electropedia: available at https://www.electropedia.org/

3.1

sex toy

manufactured product intended for sexual stimulation or to enhance sexual pleasure

Note 1 to entry: Excluded: products classified as medical devices, cosmetics or assistive products; for example, lubricants, massage oil, intimate gels/sprays, and food supplements.

3.2

intended use

use for which a product is intended according to the specifications, instructions, and information provided by the manufacturer (3.4)

[SOURCE: ISO 14971:2019, 3.6 — modified, process and service deleted, alternative term deleted]

3.3

risk

combination of the probability of occurrence of harm and the severity of that harm

[SOURCE: ISO/IEC Guide 51:2014, 3.9]

3.4

manufacturer

natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured, or fully refurbished, and markets that device under its name or trademark

Note 1 to entry: Using a third party or subcontractor does not reduce the legal responsibilities of the manufacturer, nor does it move legal responsibilities to the third party or subcontractor.

Note 2 to entry: Importing a product constitutes the same legal responsibility as of a manufacturer.

3.5

sharp edge

accessible edge of a sex toy (3.1) which presents an unreasonable risk of injury during intended use (3.2) and reasonably foreseeable misuse (3.6)

[SOURCE: ISO 8124‑1:2018, 3.33 — modified, sex toy, intended and misuse updated, hazardous deleted]

3.6

reasonably foreseeable misuse

use of a product in a way not intended by the manufacturer (3.4) but which can result from readily predictable human behaviour

Note 1 to entry: Reasonably foreseeable misuse can be intentional or unintentional.

[SOURCE: ISO 14971:2019, 3.15 — modified, system deleted, note 1 to entry deleted]

3.7

foreseeable use

use of a product that is capable of being known or anticipated in advance based on a manufacturer's (3.4) best knowledge about the product

[SOURCE: ISO 10377:2013, 2.6 — modified, supplier’s is changed to manufacturer’s]

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Bibliography

[1]		ISO 31700, Consumer protection — Privacy by design for consumer goods and services
[2]		ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
[3]		ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for skin sensitization
[4]		ISO 10993-23, Biological evaluation of medical devices — Part 23: Tests for irritation
[5]		ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
[6]		ISO 14791, Road vehicles — Heavy commercial vehicle combinations and articulated buses — Lateral stability test methods
[7]		ISO 31000, Risk management — Guidelines
[8]		ISO 10377, Consumer product safety — Guidelines for suppliers
[9]		ISO 20643, Mechanical vibration — Hand-held and hand-guided machinery — Principles for evaluation of vibration emission
[10]		ISO 5349-1, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted vibration — Part 1: General requirements
[11]		ISO 5349-2, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted vibration — Part 2: Practical guidance for measurement at the workplace
[12]		ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
[13]		ISO/IEC 30161, Internet of Things (IoT) — Requirements of IoT data exchange platform for various IoT services
[14]		IEC 60335-1, Household and similar electrical appliances - Safety - Part 1: General requirements
[15]		IEC 60335-2-29, Household and similar electrical appliances - Safety - Part 2-29: Particular requirements for battery chargers
[16]		IEC 60335-2-32, Household and similar electrical appliances - Safety - Part 2-32: Particular requirements for massage appliances
[17]		EN 55014-1, Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission
[18]		EN 55014-2, Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 2: Immunity - Product family standard
[19]		EU general risk assessment methodology (Action 5 of Multi-Annual Action Plan for the surveillance of products in the EU (COM(2013)76)

References in Annex B

[1]		Goldberg J.E., & Steele S.R. Rectal Foreign Bodies. Surg. Clin. North Am. 2010 Feb 1, 90 pp. 173–184
[2]		Barone J.E., Yee J., & Nealon T.F. Management of foreign bodies and trauma of the rectum. Surg. Gynecol. Obstet. 1983 Apr, 156 pp. 453–457
[3]		Kurer MA, Davey C, Khan S, & Chintapatla S Colorectal foreign bodies: a systematic review. Colorectal disease: the official journal of the Association of Coloproctology of Great Britain and Ireland. 2010;12(9):851-61.
[4]		Odagiri H., Yasunaga H., Matsui H., Fushimi K., Iizuka T., & Kaise M. Difference in Outcomes of Rectal Foreign Bodies between Males and Females: A Retrospective Analysis of a National Inpatient Database in Japan. Digestion. 2015, 92 (3) pp. 165–170
[5]		Lestar B., Penninckx F., & Kerremans R. The composition of anal basal pressure. An in vivo and in vitro study in man. Int. J. Colorectal Dis. 1989, 4 pp. 118–122
[6]		Griffin R., & McGwin G. Jr. Sexual stimulation device-related injuries. J. Sex Marital Ther. 2009, 35 (4) pp. 253–261

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ICS 97.170 Price based on 16 pages © ISO 2021All rights reserved	iso.org