BS EN ISO 10993-12:2009 specifies requirements and gives guidance on the procedures to be followed in the
preparation of samples and the selection of reference materials for medical device testing in biological
systems in accordance with one or more parts of the ISO 10993 series. Specifically BS EN ISO 10993-12:2009
addresses:
- test sample selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of and requirements for reference materials;
- preparation of extracts.
BS EN ISO 10993-12:2009 is not applicable to materials or devices containing live cells.
Cross References:ISO 10993-1:2003
ISO 14971
ISO Guide 30
ISO Guide 31
ISO Guide 33
ISO Guide 34
ISO Guide 35
NF S 90-701
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
, 1.2 MB |
| ISBN(s) : | 9780580658273 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 28 |
| Product Code(s) : | 30195372, 30195372, 30195372 |
| Published : | 07/31/2009 |
| Same As : | BS EN ISO 10993-12:2009 |
