ISO 15223:2000 PDF

Scope: This International Standard identifies symbols conventionally used to convey information essential for proper use to the user and others for safe and effective use of medical devices. This International Standard is primarily intended to be used by: — manufacturers of medical devices who market their products in a number of countries having different language requirements for medical device labelling; — users of medical devices who draw their supplies from a number of sources and may have varied language capabilities; — those responsible for postmarket surveillance; — health care regulatory authorities, testing organizations, certification bodies and other organizations responsible for implementing regulations affecting medical devices and having responsibility for postmarket surveillance. This International Standard may also be of assistance to: — manufacturers having to cope with space limitations on small labels; — distributors of medical devices or other representatives of manufacturers; — health care authorities responsible for training as well as those being trained. NOTE This International Standard deals with a small number of symbols that may be used when appropriate on the device itself, its package or in the accompanying documentation. Many other standards, such as IEC 60601-1, specify additional symbols that are applicable to particular kinds or groups of devices, or to particular situations.

ISO 15223:2000 history

2004 ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
2002 ISO 15223:2000/Amd 1:2002 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 1
2000 ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied