ISO 10993.2 pdf download

ISO 10993.2 pdf download.Biological evaluation of medical devices 1 Scope This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing. This part of ISO 10993 is also intended a) to establish guidelines which allow the scientist to respect life in general; b) to reduce the number of animal experiments and the number of animals used in experiments, among other ways by optimization of those performed; c) to minimize suffering and maintain the quality of life of the animals used in the experiments. This part of ISO 10993 applies to the experimentation performed on vertebrates. It does not apply to experimentation performed on less differentiated animals; nor does it apply to that part of the experimental work performed on isolated tissues and organs. This part of ISO 10993 also makes recommendations concerned with the aim of reducing the number of animals used for biocompatibility testing and when possible abolishing animal experiments in this area. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this part of ISO 10993. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 10993-1:1992, Biological evaluation of medical devices — Part 1: Guidance on selection of tests. 3 Definitions For the purposes of this part of ISO 10993, the definitions given in ISO 10993-1 and the following definitions apply. 3.1 animal any live non-human vertebrate, excluding foetal or embryonic forms, unless otherwise qualified 3.2 experimental animal animal used or to be used in experiments 3.3 bred animal animal specially bred for use in experiments in facilities accredited by, or registered with, the competent authority 3.4 animal experiment any use of an animal for scientific purposes which may cause it pain, anxiety, suffering, distress or lasting harm, excluding the least painful methods accepted in modern veterinary or laboratory practice (i.e. “humane” methods) of killing or marking an animal an experiment starts when an animal is first prepared for use and ends when no further observations are to be made for that experiment NOTE 1 The prevention, elimination and minimization of pain, suffering, distress or lasting harm...