BS EN ISO 10993-13:2010 provides general requirements for the design of tests in a simulated environment for
identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
BS EN ISO 10993-13:2010 describes two test methods to generate degradation products, an accelerated
degradation test as a screening method and a real-time degradation test in a simulated environment. For
materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data
generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only nonresorbable
polymers. Similar but appropriately modified procedures may be applicable for resorbable
polymers.
BS EN ISO 10993-13:2010 considers only those degradation products generated by a chemical alteration of the
finished polymeric device. It is not applicable to degradation of the device induced during its intended use by
mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins
and cellular activity.
NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid
to the design of degradation studies (see Annex B).
The biological activity of the debris and soluble degradation products is not addressed in this part of
ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 and
ISO 10993-17.
Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques
are identified or given preference. No specific requirements for acceptable levels of degradation products are
provided in BS EN ISO 10993-13:2010
Cross References:ISO 3696
ISO 10993-1
ISO 10993-9
ISO 10993-12
ISO 10993-17
ISO 13781
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
, 1.3 MB |
| ISBN(s) : | 9780580577192 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 28 |
| Product Code(s) : | 30156452, 30156452, 30156452 |
| Published : | 10/31/2010 |
| Same As : | BS EN ISO 10993-13:2010 |
