GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2: Animal welfare requirements
1 Scope
This part of GB/T 16886 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.
It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing with in a risk management process
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
3.1
alternative method
any test method that replaces an animal test, reduces the numbers of animals used, or refines the procedures applied
3.2
animal
any live non-human vertebrate, excluding immature forms during the first half of gestation of incubation
3.3
animal test
any use of an animal for scientific purposes
Note 1: 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.
Note 2: 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, or the breeding and supply of purpose-bred animals for use on such tests, within the scope of this part of GB/T 16886
3.5
euthanasia
humane killing of an animal by a method causing a minimum of physical and mental suffering
3.6
humane endpoints
pre-determined, specific criteria and measures to be implemented to minimize or terminate pain, suffering or distress caused by animal tests as soon as the scientific objectives have been met, or when it is realized they cannot be met, or when the animal welfare problems being encountered are greater than can be justified by the importance, potential benefits, objectives and nature of the study
3.7
procedural training
prior training and acclimatizing of animals to the interventions to be performed during an animal test, with a view to minimizing stress to the animal when animal tests are conducted
3.8
protocol
documentation prepared in advance of animal tests being undertaken setting out the justification, rationale and test method (including scientific and humane endpoints) for the animal tests
3.9
purpose-bred animal
any animal bred with the intention that it be used in animal tests or for other experimental or scientific purposes
3.10
reduction
reducing to the essential minimum the number of animals used in an animal test to meet a defined scientific objective
3.11
refinement
sum total of measures taken to safeguard the welfare of the test animals by minimizing any resulting pain, suffering, distress or lasting harm to the animals that are used
3.12
replacement
any scientifically valid and reasonably and practically available test method that either completely or partially replaces the use of living vertebrate animals with test methods that have not the potential to cause pain or distress to animals
3.13
test animal
any animal used in in vivo animal tests, or used to provide tissue for ex vivo or in vitro tests
3.14
validation
formal process by which the reliability and relevance of a test method is established for a particular purpose
4 Requirements
4.1 General
This part of ISO 10993 sets forth essential requirements when animal tests are being considered, planned or performed for the biological evaluation of materials used in medical devices.
It has been developed to protect the welfare of animals used in the biological evaluation of materials used in medical devices without compromising, indeed to help to ensure, the scientific validity of the test results and the risk assessments that shall subsequently be performed.
This part focuses on the need to demonstrate that animal welfare is properly considered when expert judgement has to be exercised in relation to the biological evaluation of medical device materials, and that the principles of humane experimental technique are demonstrably applied to the design and conduct of animal tests.
This part requires that the need to perform animal tests is justified, and any pain, suffering, distress or lasting harm that is caused during essential animal tests is minimized.
This part sets out essential requirements that safeguard animal welfare by minimizing the pain and distress caused when animal tests are considered or undertaken by:
a) establishing a framework that reflects the relevant ethical and, in many jurisdictions， the legal considerations relating to the use of animals for experimental or other scientific purposes;
b) minimizing the number of animal tests by the appropriate use of literature searches, data-sharing, validated replacement alternatives, and appropriate testing strategies and study designs;
c) minimizing any pain, suffering, distress and lasting harm caused to animals used in tests to evaluate the biocompatibility of materials used in medical devices by requiring appropriate use of relevant reduction and refinement alternatives;
Contents
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (Informative) Rationale for the development of this part
Annex B (Informative) Further suggestions for replacing, reducing and refining animal tests
Bibliography
GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2: Animal welfare requirements
1 Scope
This part of GB/T 16886 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.
It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing with in a risk management process
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
3.1
alternative method
any test method that replaces an animal test, reduces the numbers of animals used, or refines the procedures applied
3.2
animal
any live non-human vertebrate, excluding immature forms during the first half of gestation of incubation
3.3
animal test
any use of an animal for scientific purposes
Note 1: 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.
Note 2: 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, or the breeding and supply of purpose-bred animals for use on such tests, within the scope of this part of GB/T 16886
3.5
euthanasia
humane killing of an animal by a method causing a minimum of physical and mental suffering
3.6
humane endpoints
pre-determined, specific criteria and measures to be implemented to minimize or terminate pain, suffering or distress caused by animal tests as soon as the scientific objectives have been met, or when it is realized they cannot be met, or when the animal welfare problems being encountered are greater than can be justified by the importance, potential benefits, objectives and nature of the study
3.7
procedural training
prior training and acclimatizing of animals to the interventions to be performed during an animal test, with a view to minimizing stress to the animal when animal tests are conducted
3.8
protocol
documentation prepared in advance of animal tests being undertaken setting out the justification, rationale and test method (including scientific and humane endpoints) for the animal tests
3.9
purpose-bred animal
any animal bred with the intention that it be used in animal tests or for other experimental or scientific purposes
3.10
reduction
reducing to the essential minimum the number of animals used in an animal test to meet a defined scientific objective
3.11
refinement
sum total of measures taken to safeguard the welfare of the test animals by minimizing any resulting pain, suffering, distress or lasting harm to the animals that are used
3.12
replacement
any scientifically valid and reasonably and practically available test method that either completely or partially replaces the use of living vertebrate animals with test methods that have not the potential to cause pain or distress to animals
3.13
test animal
any animal used in in vivo animal tests, or used to provide tissue for ex vivo or in vitro tests
3.14
validation
formal process by which the reliability and relevance of a test method is established for a particular purpose
4 Requirements
4.1 General
This part of ISO 10993 sets forth essential requirements when animal tests are being considered, planned or performed for the biological evaluation of materials used in medical devices.
It has been developed to protect the welfare of animals used in the biological evaluation of materials used in medical devices without compromising, indeed to help to ensure, the scientific validity of the test results and the risk assessments that shall subsequently be performed.
This part focuses on the need to demonstrate that animal welfare is properly considered when expert judgement has to be exercised in relation to the biological evaluation of medical device materials, and that the principles of humane experimental technique are demonstrably applied to the design and conduct of animal tests.
This part requires that the need to perform animal tests is justified, and any pain, suffering, distress or lasting harm that is caused during essential animal tests is minimized.
This part sets out essential requirements that safeguard animal welfare by minimizing the pain and distress caused when animal tests are considered or undertaken by:
a) establishing a framework that reflects the relevant ethical and, in many jurisdictions， the legal considerations relating to the use of animals for experimental or other scientific purposes;
b) minimizing the number of animal tests by the appropriate use of literature searches, data-sharing, validated replacement alternatives, and appropriate testing strategies and study designs;
c) minimizing any pain, suffering, distress and lasting harm caused to animals used in tests to evaluate the biocompatibility of materials used in medical devices by requiring appropriate use of relevant reduction and refinement alternatives;
Contents of GB/T 16886.2-2011
Contents
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (Informative) Rationale for the development of this part
Annex B (Informative) Further suggestions for replacing, reducing and refining animal tests
Bibliography
