Edit: Please try and read this as seriously as possible, kthanx.



We have these little rubber things originally designed as contraceptives, although of course with many more varied uses too. I'm sure most of you are familiar with them, they're in pretty common use. But what exactly are these things, "real" ones, officially? The last time the International Standards Organisation told us was in July of 2002.

The ISO has dictated that although the non-active medical devices are non-sterile devices, they are still medical devices and as such, manufacturers need to minimise microbiological contamination of them. Fair enough. The open end of the device shall terminate in an integral bead? Yeah, so like any other normal balloon. Dimensions: No device should be shorter than 160 mm, but there is no maximum or minimum diameter, nor indeed do the devices even have to be round. Well, wouldya know that? All devices should be strong enough to withstand no less than 1.0 kPa before bursting. Volumes are also specified as to how far various sizes of device should be able to stretch. So you think you've got an "extra-strength" device, 'ey? Well in that case, it should be able to withstand a whole extra kilopascal, and at least 100 N. Extra-strength devices must have a minimum single wall thickness at the mid body of more than 0.060 mm, but there is no minimum wall thickness for a standard device.

No shelf life, even if you have proved otherwise, can exceed five years. It's just not possible. All device designs must undergo real-time beta testing to ensure this is the case. Sections 8 and 9 of the Standard demand that no holes, visible or invisible shall be present in test samples, neither shall there be visible defects, that is those that do not require a microscope to detect.

Each device shall be packed in an individual container. Yes, well in keeping with their official purpose in life, devices are not allowed to come into contact with other devices. It is permissible to pack these individually wrapped devices inside a second layer of packaging. At least one of these shall be opaque, and protect the devices from light as UV is detrimental to the latex rubber. Whichever piece of packaging is chosen to be opaque, the device must be protected from exposure to light at all times. No packaging or labelling thereon or on the device itself shall have any deleterious effect on the device, nor shall it be harmful to the user. It might be nice if people other than "the user" were covered here, but they are not. All packaging shall protect the device from damage of any form during both transport and storage, but I've yet to see one of these devices ship from a manufacturer in anything like an ammo box or Pelican. All packaging shall also be designed in such a way as to facilitate easy opening without damaging the device, it does not however have to be easily openable to the point of being able to remove the device from it.

Individual packaging of all devices shall have on it as a minimum: the manufacturer or distributor's identity, the identifying reference of the same, and the expiry date of the device in the format of "YYYY, MM" or "YYYY, Month." The outside of the consumer package shall contain in at least one official language of the target country at least: a description of the device, including whether or not it has a reservoir, colour or texture if applicable, the quantity of devices, the devices' nominal width, the name or trade name and address of the manufacturer and/or distributor, the expiry date of the devices, earliest of inconsistent, a statement to store the device in a cool dry place away from direct sunlight, a statement on storage to protect from light in the case of non-opaque individual containers, whether or not the device is lubricated and/or fragranced as well as the identity of any medicinal ingredients, the manufacturer's identifying reference, and a statement that the device is made from natural rubber latex. That's a lot of information, right? No, you're not allowed to use a QR code, the information must all be human-readable even if printed so tiny as to actually not be readable by humans. Not only all that, but the manufacturer is also required to include on the consumer package, or a leaflet contained within it, in simple terms in at least one of the target country's official languages, and preferably with accompanying pictorial representations, the major steps involved in proper handling, use and disposal of the device, a statement that the device is for single use, and a reference to the International Standard.

So next time you're using one of these, try not to think of it as just a rubber tube, 'cos it's not, really.



If you have any questions regarding the above discussed devices, please feel free to /msg me or grab a copy of the Standard from you local library or from the ISO themselves.

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