ISO 10993-2:2022 医療機器の生物学的評価 — Part 2: 動物福祉要件 | ページ 6

3.1

alternative method

test method that replaces an animal test (3.3) , reduces the numbers of animals (3.2) used or refines the procedures applied

3.2

animal

live non-human vertebrate, excluding immature forms during the first half of gestation or incubation

3.3

animal test

use of an animal (3.2) for scientific purposes

Note 1 to entry: The definition of an animal test excludes acts of recognized veterinary practice applied for the benefit of an animal or the group of animals of which it is part; recognized husbandry practices to manage or conserve the animal or the group of which it is part; marking by methods which cause no more than momentary pain or distress; and euthanasia (3.5) .

Note 2 to entry: The prevention of pain, suffering, distress or lasting harm by the effective use of anaesthesia or analgesia or other methods of rendering the animal insentient to pain (e.g. decerebration) does not place animal tests outside the scope of this definition. The administration of anaesthetics, analgesics or other methods of rendering the animal insentient to pain are considered to constitute an integral part of the animal test.

3.4

competent authority

body designated or recognized by a national government to take responsibility for overseeing, supervising or regulating animal tests (3.3) , or the breeding and supply of purpose-bred animals (3.10) for use on such tests, within the scope of this document

3.5

euthanasia

humane killing of an animal (3.2) by a method causing minimal physical and mental suffering

3.6

humane endpoint

3.7

laboratory animal veterinarian

qualified laboratory animal veterinarian

person responsible for the health and well-being of all laboratory animals (3.2) used at the institution

Note 1 to entry: Often called “attending veterinarian” who is certified or has training or experience in laboratory animal science and medicine or is otherwise qualified in the care of the species being used.

Note 2 to entry: It is recommended that a laboratory animal veterinarian appropriately qualified by the relevant competent authority should be used as an attending veterinarian.

Note 3 to entry: There is an International Association of Colleges of Laboratory Animal Medicine (IACLAM) that is an association of associations, specifically the member Colleges of laboratory animal medicine. Each college has members that, in addition to their demonstrated proficiency in laboratory animal medicine, also possess subspecialization in a variety of areas that have direct bearing on the care, use and welfare of laboratory animals.

3.8

procedural training

prior training and acclimatizing of animals (3.2) to the interventions to be performed during an animal test, with a view to minimizing stress to the animal when animal tests are conducted

3.9

protocol

documentation prepared in advance of animal tests (3.3) being undertaken setting out the justification, rationale and test method [including scientific and humane endpoints (3.6) ] for the animal tests

3.10

purpose-bred animal

animal (3.2) bred with the intention that it be used in animal tests (3.3) or for other experimental or scientific purposes

3.11

reduction

decrease to the essential minimum the number of animals (3.2) used in an animal test (3.3) to meet a defined scientific objective

3.12

refinement

total of the measures taken to safeguard the welfare of the test animals (3.14) by minimizing any resulting pain, suffering, distress or lasting harm to the animals (3.2) that are used

3.13

replacement

scientifically valid and reasonably and practically available test method that either completely or partially replaces the use of living vertebrate animals (3.2) with test methods that have not the potential to cause pain or distress to animals

3.14

test animal

animal (3.2) used in in vivo animal tests (3.3) , or used to provide tissue for ex vivo or in vitro tests

3.15

validation

formal process by which the reliability and relevance of a test method is established for a particular purpose

3.16

veterinary care

responsibility for promoting an animal’s (3.2) health and welfare before, during and after animal procedures and providing advice and guidance based on best practice

Note 1 to entry: Veterinary care includes attention to the physical and behavioural status of the animal.

Note 2 to entry: The laboratory animal veterinarian (3.7) shall have authority and responsibility for making judgements concerning animal welfare.

Note 3 to entry: Veterinary advice and care shall be available at all times.