ISO 3533 is the first international standard for sex toys in the world. ISO 3533 was published in 2021 and covers the design and safety requirements for sex toys that are designed to come in direct contact with the genitalia, the anus, or both.

ISO 3533 covers specifications such as design, materials, components, and user instructions for sex toys. It doesn’t products that are classified as medical devices or assistive products, including lubricants and massage oil.

ISO 3533 specifies the safety standards and requirements for sex toys that are used for sexual stimulation or to enhance sexual pleasure. This standard covers sex toys that are designed to be in direct contact with the genitals and or the anus.

ISO 3533 does not cover items that are classified as medical devices or assistive products. Examples of such products are:

Lubricants

Massage oil

Intimate sprays

Electrical safety requirements

ISO 3533 sets out electrical safety requirements for sex toys that fall under the scope of this standard. Importers and manufacturers of sex toys should take into account the electrical safety of the product and its batteries or charger (if any), during the usage and charging conditions.

Mechanical safety requirements

The standard also sets out the mechanical safety requirements for sex toys, which concern aspects such as the following:

Prevention of retention

Products for genital enclosure

Moving parts

Removable components

According to the standard, importers and manufacturers should design their products ensuring that they won’t harm the users in foreseeable or unforeseeable ways, from the perspective of product design, dimensions, and materials.

Labeling requirements

ISO 3533 states that the product or packaging for sex toys should contain information such as the following:

Product information

Product identity (e.g. SKU, lot number)

Intended usage

Information about the battery or charger (if applicable)

Overview of the product’s parts and accessories

User instructions

CPSC Standards

Safety standards

Even if there are no specific CPSC safety rules or mandatory standards that apply specifically to sex toys, importers or manufacturers can refer to safety standards concerning aspects such as the chemical, electrical, and mechanical safety of the products, such as:

ISO 3533 – Sex toys

UL safety standards (e.g. electrical or battery safety standards)

ASTM standards (e.g. ASTM F963 for sharp edges)

16 CFR Part 1303 – Ban Of Lead-Containing Paint and Similar Surface Coatings

UL Electrical safety standards

Below are examples of UL standards that concern the electrical safety of products. Importers or manufacturers may refer to these standards for their electronic sex toys (if applicable):

a. UL 62368-1 Audio/Video, Information and Communication Technology Equipment – Part 1: Safety Requirements

b. UL 60335-1 Safety of Household and Similar Appliances, Part 1: General Requirements

Batteries safety standards

Below are examples of UL standards that concern the safety of batteries. These standards may be applied to sex toys that are operated by batteries:

a. UL 1642 – Lithium Batteries

b. UL 2054 – Household and Commercial Batteries

Flammability safety standards

UL also develops flammability standards for devices components, such as:

a. UL 94 – Tests for Flammability of Plastic Materials for Parts in Devices and Appliances

FCC Part 15

FCC Part 15 sets limitations on the amount of electromagnetic interference emitted by electronic devices. It regulates electronic and electrical devices that operate in the radio frequency range of 9 kHz to 3000 GHz.

Hence, FCC Part 15 can be applied to electronic sex toys.

Devices Classification

The FCC mainly classifies electronic devices into two categories:

a. Unintentional radiators, that is devices that generate electrical signals within the product but are not designed to emit radiofrequency energy by radiation or induction

b. Intentional radiators, that is devices that generate and emit radiofrequency energy by radiation or induction

Importers and manufacturers of electronic sex toys should comply with the specific FCC requirements in accordance with the categories of their products.

Requirements

In this section, we briefly introduce the requirements for unintentional radiators and intentional radiators.

Unintentional radiators

Sex toys that are categorized as unintentional radiators, such as vibrators that don’t have any wireless or Bluetooth feature, should comply with FCC’s requirements on unintentional radiators, including:

Supplier Declaration of Conformity (SDoC)

Traceability label

Compliance statement

Test report

Intentional radiators

Sex toys that are categorized as intentional radiators, such as items that are operated with Wi-Fi or Bluetooth, should comply with FCC’s requirements on intentional radiators, including:

Certification (granted by an FCC-recognized telecommunication certification body)

Traceability label (including FCC ID)

Compliance statement

Test report

ANSI Standards

The FCC Knowledge Database provides guidance and examples of testing standards for electronic devices, including:

a. ANSI C63.4 Methods Of Measurement Of Radio-Noise Emissions From Low-Voltage Electrical And Electronic Equipment In The Range Of 9 KHz To 40 GHz (for unintentional radiators)

b. ANSI 64.5 Unlicensed Wireless Devices Compliance Testing (for intentional radiators)

Importers and manufacturers of electronic sex toys can refer to ANSI standards to demonstrate compliance with FCC requirements.

FDA (CFR Title 21)

If your products are designed to be in contact with the genital parts for therapeutic purposes, they might be regulated as medical devices by the FDA. Examples of such products include:

Kegel balls (used to tighten the muscles of the pelvic floor and improve incontinence)

Genital vibrators (use in the treatment of sexual dysfunction)

Personal lubricants are also classified as medical devices by the FDA as they are used to enhance the comfort of intimate sexual activity and supplement the body’s natural lubrication.

Devices classification

The FDA classifies medical devices into three classes:

Class I (low to medium risk): subject to General Controls

Class II (medium to high risk): subject to General Controls and Special Controls

Class III (high risk): subject to General Controls and Premarket Approval (PMA)

Importers and manufacturers of lubricants, vibrators, and other products that might fall under FDA regulations should contact a testing company or consultant to confirm whether their products are classified as medical devices.

Requirements

FDA’s requirements for medical devices might include:

510(k) submission

Labeling

Good Manufacturing Practices (GMP)

Device registration and listing

Notification and repair, replacement, and refund

Records and reports

California Proposition 65

California Proposition 65 prohibits the use of excessive toxic chemicals in consumer products without using the appropriate warnings, in the state of California. The proposition covers most consumer products, including sex toys.

Substance restrictions

California Proposition 65 regulates chemicals that are naturally existing or intentionally added to the products and that can cause health problems to humans. Below are examples of materials that might be found in sex toys, and that might contain substances that are restricted by California Proposition 65:

Silicone, which might contain phthalates

Plastic, which might contain phthalates

Metal, which might contain lead, cadmium, or chromium

Warning requirements

California Proposition 65 requires importers or manufacturers to place warning labels on the products if they contain an excessive amount of restricted chemicals5. The label is to notify consumers that such products contain, or might contain, carcinogens or toxins to human reproductive systems.

California Proposition 65’s warning requirements include:

Label format and content

Warning symbol and text

Warning statement

PTS Testing Service Lab Testing

PTS Testing Service Lab testing is necessary for verifying that a certain sex toy is safe and fully compliant. The testing protocol depends on the product type, but can cover the following:

Battery safety testing

Mechanical safety testing

Chemicals and heavy metals testing

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