Medical Grade

Last modified by Hypno Harem on 2022/07/19 18:54

A term used to imply that something is safe, which is more often than not an example of Faux-Safety.

Medical Grade can be a contentious topic as it does not have a set definition and is not a regulated term. Whether or not it is "Real" depends on the level of nuance used in the argument, with the correct answer following this pattern:

  • Correct: "Medical Grade is not a real thing, anyone can call anything medical grade"
  • More Correct: "Medical Grade is a real thing when applied to some materials designed to be used in medical devices"
  • Most Correct: "Medical Grade is not real because regulatory bodies only certify the finished medical device"
  • Mostest Correct: "Medical Grade is real if you're a dentist"

Image shows meme about medical grade

Confusion about this term comes from other industries using it extensively to deceive consumers into believing their products are of a superior or “medical” quality, while having no legal requirement to actually manufacture the product to any set standard. It is further confounded by companies using medical grade where it is not readily apparent that what they are producing is for o-rings, valves, sheets, tubes, and gaskets that are used in medical equipment but not for use on or in the human body. Any type or class of silicone can be called medical grade at the manufacturer's discretion as this is not illegal. In this sense, medical grade is not real. However, there are silicones such as Class IV or Class V products which are specifically designed for use in medical devices, have a regulated definition, and the use of the term may only be applied to materials having undergone the appropriate and rigorous biocompatibility testing. In this sense, medical grade is real.

The deepest understanding of the topic requires looking at how medical devices are regulated. In medical devices, raw materials like silicone do not receive a catch-all certification like “medical grade,” because what makes them the correct “grade” differs greatly depending on the job they are to perform. Silicone used to make the cushioning pad for a dental drill can be quite different from what is needed to make a heart valve. The drill pad has no need for the silicone to be particularly biocompatible or even pass a dermal sensitization test since it will be handled with gloves. Likewise, the heart valve has little need to be heat or chemical resistant as it will not undergo the repeated cleanings of the dental instrument.

Rather than certify the individual raw materials, regulating bodies like the FDA certify the entire medical device. This allows testing to catch the impacts of the raw materials, as well as those of any additives that were used and cure conditions. Standards are in place such as ISOs that can help guide manufacturers in how to choose and use raw materials, and may dictate what tests should be performed and how. These may include testing to standards such as ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.

Most of the silicones used in indie adult novelty have had similar testing performed and are sold as “Skin Safe” or include a statement of what standard was used to test them. They do not, however, use medical grade anywhere in their advertising material or technical documentation. Companies producing supposedly medical grade adult novelties are normally adding this term after the fact and without ever having seen it in their material documentation.

Preferred terms include “Certified Skin Safe Silicone,” “Body Safe,” “ISO Certified Silicone,” or “Platinum Cure Silicone” depending on materials used.

An important note is that a certification of skin safety or certification that a material complies with an ISO standard does not apply to the entire toy. It only applies to the silicone itself, and most of the time only to the unpigmented silicone. Things like mold release, cure inhibition, or pigment leaching can all potentially, though very rarely, render a toy unsafe despite the silicone used. A claim that a toy is medical grade rather than the silicone and possibly pigments used will be false.

Goblin Note: Do you need to use a Class IV or V silicone? Probably not. Indie makers tend towards being overly cautious and may try to seek out a silicone that can be appropriately called medical grade. These silicones have a number of drawbacks including their cost, relative difficulty sourcing, and a lack of community knowledge in their use; making troubleshooting more difficult. Using the term medical grade my also be seen as a yellow flag by some well-versed customers. If you do choose to go way above and beyond and source these silicones, consider including a discussion about where yours comes from in the FAQ to address concerns.


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