BS EN ISO 10993-17:2009 specifies a method for the determination of allowable limits for substances leachable from
medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do
not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous
substances present in medical devices can be quantified.
BS EN ISO 10993-17:2009 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or
air. BS EN ISO 10993-17:2009 does not address the potential for exposure from such sources.
Cross References:ISO 10993-1
ISO 10993-7
ISO 14971
93/42/EEC
90/385/EEC
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 1 MB |
| ISBN(s) : | 9780580658235 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 36 |
| Product Code(s) : | 30195362, 30195362, 30195362 |
| Published : | 06/30/2009 |
| Same As : | BS EN ISO 10993-17:2009 |
