Technical requirements for personal protective equipment (PPE)
UNICEF's rerquirements for personal protective equipment suppliers and products
The personal protective equipment (PPE) referred in this document is for protective clothing, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. Some products may appear to have a medical purpose, but their purpose is to protect the user. Such products are considered as PPE rather than medical devices.
All PPE intended for use as a medical device must meet specific performance standards for protection and be ‘’Conformité Européene” (CE) marked as a medical device. For example, protective masks (e.g. from the environment) are not considered medical devices but PPE. However, a surgical mask used in an operating theatre to protect the user is considered a medical device.