BS ISO 15223-2:2010 ✓ Most Recent

1721646

Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied-Symbol development, selection and validation

standard by British Standard / International Organization for Standardization , 06/30/2010

Track This

Multi-User PDF

Identical Versions Available

Full Description

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

The purpose of BS 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 this part of ISO 15223 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.

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

Cross References:
ISO 9186-1:2007
ISO 15223-1:2007
ISO 80416-2
IEC 80416-1:2008
ISO 7000
ISO 7010
ISO/TR 7239
ISO 14971
ISO 15225
IEC 60417-DB
IEC/TR 60878
IEC 80416-3
EN 980
IEC 62366


All current amendments available at time of purchase are included with the purchase of this document. See more

Also Bought By Customers

 

Document History

  1. BS ISO 15223-2:2010

    👀 currently
    viewing


    Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied-Symbol development, selection and validation

    • Most Recent

  2. BS 08/30154605 DC


    BS ISO 15223-2. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 2. Symbol development, selection and validation

    • Historical Version

Order Options

Delivery Options
Price: $279.40
Available for Immediate Download

Product Details

Published:

06/30/2010

ISBN(s):

9780580575327

Number of Pages:

28

File Size:

1 file

Same As:

ISO 15223-2:2010

Product Code(s):

30154607, 30154607, 30154607

Note:

This product is restricted and cannot be purchased in the following countries Russia, Ukraine, Belarus