BS EN ISO 10993 series

Biological evaluation of medical devices
BS EN ISO 10993 are being revised to contain informative annexes that identify the sections of the standard that conform to the Medical Devices Directives 93/42/EEC and 90/385/EEC, for medical devices and active implantable medical devices.

The BS EN ISO 10993 series consists of the following parts, under the general title Biological evaluation of medical devices:

BS EN ISO 10993-1:2009
Biological evaluation of medical devices. Evaluation and testing

BS EN ISO 10993-2:2006
Biological evaluation of medical devices. Animal welfare requirements

BS EN ISO 10993-3:2009
Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity

BS EN ISO 10993-4:2002
Biological evaluation of medical devices. Selection of tests for interactions with blood

BS EN ISO 10993-5:2009
Biological evaluation of medical devices. Tests for in vitro cytotoxicity

BS EN ISO 10993-6:2009
Biological evaluation of medical devices. Tests for local effects after implantation

BS EN ISO 10993-7:2008

Biological evaluation of medical devices. Ethylene oxide sterilization residuals

BS EN ISO 10993-9:2009
Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products

BS EN ISO 10993-10:2002
Biological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivity

BS EN ISO 10993-11:2009
Biological evaluation of medical devices. Tests for systemic toxicity

BS EN ISO 10993-12:2009
Biological evaluation of medical devices. Sample preparation and reference materials

BS EN ISO 10993-13:2009
Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices

BS EN ISO 10993-14:2009
Biological evaluation of medical devices. Identification and quantification of degradation products from ceramics

BS EN ISO 10993-15:2009
Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys

BS EN ISO 10993-16:2009
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables

BS EN ISO 10993-17:2009
Biological evaluation of medical devices. Establishment of allowable limits for leachable substances

BS EN ISO 10993-18:2009
Biological evaluation of medical devices. Chemical characterization of materials


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