Please select and order
€85.85
excl. VAT
Add to cart
Norm

ISO 15223-2:2010

Issue date: 2010 01 15

Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of ISO 15223-2:2010 is to ensure that symb...
Valid

ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

ISO 15223-2:2010
2010 01 15
Medical devices — Symbols to be used with medical device labels, labelling, and information to be su...
Norm
ISO 15223:2000/Amd 2:2004
2004 01 28
Medical devices — Symbols to be used with medical device labels, labelling and information to be sup...
Norm
ISO 15223:2000/Amd 1:2002
2002 08 15
Medical devices — Symbols to be used with medical device labels, labelling and information to be sup...
Norm
ISO 15223:2000
2000 04 13
Medical devices — Symbols to be used with medical device labels, labelling and information to be sup...
Norm
ISO/TR 15223:1998
1998 10 15
Medical devices — Symbols to be used with medical device labels, labelling and information to be sup...
Technische Regel
Expand