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BS EN 15986:2011

Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

standard by British-Adopted European Standard , 03/31/2011

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Full Description

BS EN 15986:2011 specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling.

BS EN 15986:2011 does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041. BS EN 15986:2011 does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.



Cross References:
93/42/EEC
67/548/EEC
Regulation (EC) No 1272/2008
ISO 7000
EN 12264:2005
prEN ISO 15223-1:2009
ISO/DIS 15223-1:2009
EN 80416-3:2002
IEC 80416-3:2002
EN 980:2008
ISO 15223-1:2007
EN 1041


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

Product Details

Published:
03/31/2011
ISBN(s):
9780580682605
Number of Pages:
16
File Size:
1 file , 600 KB
Product Code(s):
30205583, 30205583
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN 15986:2011

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    Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

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  2. BS 09/30205582 DC


    BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

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