Currently getting a sex toy CE marked and put onto the market is relatively easy, in that sex toys are covered by the General Product Safety Directive (GPSD), the same as any other consumer product marketed in the EU. Basic safety and registration, and although there is no harmonised standard for sex toys, manufacturers can look to other standards to ensure the product safety e.g., EN61959 – (battery safety), RoHS Directive (heavy metals and chemical restrictions), EMC Directive and Low Voltage Directive (e.g., plug adapters).
However, all of these only look at the safety of the secondary factors of the sex toy e.g., batteries, and not at the toy itself, and this is where ISO 3533:2021 (Sex toys – Design for safety requirements for products in direct contact with genitalia, the anus, or both), paves the way.
ISO 3533 is based upon something important, evidence. There is increasing evidence of hospital admissions and case reports of bodily retained foreign objects. For example, in a recent 2019 study in Sweden of patients admitted to Stockholm South General Hospital between 2009 and 2017, 85 patients presented with a retained rectal object1. The same study also showed the incidence rate of this was increasing in men and women. Although it could be surmised this number is not be a true representation of the actual number, for example people who managed to retrieve the objects themselves or with assistance from a partner. Best case is this is embarrassing, worst case severe internal trauma and death.
It seems pragmatic therefore for this standard to come into existence, as the standard is built around a risk-based approach to the design and manufacture of the sex toy (product), in addition to the “usual’s” mandated by the GPSD.
ISO 3533 is primarily aimed at the designers and manufacturers who must be aware of the potential hazards or misuse and the risk these products pose to the user. Also, the responsibility is not finished once the product is on the market. The manufacturer is expected to gather information post-sales including customer feedback to address recalls, complaints and improve the products.
All products must be designed based on intended use and must include requirement specifications and risk assessment including shape, size, materials, packaging and user information.
Design safety
The manufacturer must document a risk assessment which will consider the anatomy of the user when designing the product so that retention is minimised, and the user has the ability to remove it themselves rather than seeking medical assistance, which should go some way to reduce the number of accidents and hospital admissions.
In addition, products such as penile rings and chastity devices must be able to be safely removed by the user without the need for specialist equipment to be used.
In line with GPSD, products which are mains powered must consider electrical safety based on intended use and reasonably foreseeable misuse. Devices with vibration must be risk assessed and consider standards ISO 5349-1, 5349-2 (Mechanical vibration – measurement and evaluation of human exposure to hand-transmitted vibration) and ISO 20643 (Mechanical vibration – hand-held and hand-guided machinery). In addition, products that use electrical impulses to stimulate genitalia should be qualified by a certified laboratory.
Material safety
ISO 3533 outlines the product must not contain any chemical in quantities which are known to be harmful, and a helpful list is provided to assist manufacturers, although a reference to RoHS may be more useful. Also, in line with GPSD, materials used within the product must be supported with biocompatibility data for example ISO 10993-10 (Tests for irritation and skin sensitization) and 10993–23 (Tests for irritation).
The standard also suggests the manufacturer should introduce a procedure to identify the laws and regulations of countries where the product is to be manufactured, imported, distributed, and sold to ensure these legal requirements are met.
User information
Data the manufacturer must provide the user of the product is much more detailed and robust. For example, there must be clear instructions for turning the device off and on, lot/batch or serial number description of product functionality, intended use, specification of material to be in contact with genitalia, anus/rectum or both, information about battery and or charging as well as if the product is compliant to ISO 3533
When does a sex toy become a medical device?
Certain parallels can be drawn between some sex toys and those regulated as medical devices. For example, TensCare’s Viva, a CE marked medical device, is designed to be inserted into the vagina where electrical stimulation is used for the treatment of urinary incontinence. However, similar TENS based devices which are marked for sexual use, for example E-Stim products, only have basic electrical safety compliance.
In addition, there is currently active recruitment for a US clinical trial to assess the effect of commercial vibrators on female sexual health including pelvic floor disorders2. Therefore, if vibrators are used in this capacity, could they be prescribed to a patient? Therefore there must be a duty of care or due diligence by the medical practitioner in ensuring safety to their patients.
Despite similarities between them, the difference between sex toys and medical devices is their intended use, and whether a product falls under the definition of a medical device in accordance with ISO 13485 and medical device regulations. This is why ISO 3533 is so important, as it bridges the gap between what is a sensible approach to sex toy design and manufacture without going down the route of a medical device technical file submission!
What is not considered
ISO 3533 is built around a risk-based approach, which assumes the manufacturer or designer is aware of risk assessments and what they entail. Certainly, Annex A in the standard gives guidance here, but without the deeper level of knowledge for example ISO 14971 (risk management for medical devices), certain hazards may be overlooked or the level of risk to the consumer not carefully considered. In addition, clinical expertise may be required for ensuring anatomy is considered correctly which may become an extra cost and time burden to the manufacturer.
Like so many other connected devices (medical and lifestyle), security of user data must be a consideration. Many sex toys on the market have connectivity to a related App on a user’s phone via Bluetooth, where function of the product can be controlled via the user or their partner. For example, much of the product range from Lovense can be connected to “Lovense Remote”. Although, this may seem rather innocuous, manufacturers must ensure users of their products are taking necessary preventative steps to ensure that their data is secure. In addition, the manufacturer or the third party used to manage the app, must ensure that all necessary steps are taken to ensure confidentiality, integrity and availability of data, especially if under regulations such as the General Data Protection Regulation.
In conclusion, ISO 3533 is paving the way for increased consumer satisfaction (in more than one sense perhaps!). With sales of sex toys increasing over the years (in 2020 a global market of estimated at US$35.1 Billion and projected to grow to US$54.6 Billion in 20263), it was only a matter of time before intimate sex toys became under better design and manufacturing control. The motivation behind the standard was to reduce the number of hospital admissions linked to retention of foreign objects. If this standard is followed, effective mitigations of risks identified can be implemented, but this may rely on manufacturers knowing their limits and reaching out for help.
References
1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318238/
2: https://www.clinicaltrials.gov/ct2/show/NCT04824820
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