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