GB/T 44353.1-2024 Medical devices utilizing animal tissues and their derivatives-Part 1 : Application of risk management
1 Scope
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
Note 1: It is not a requirement of this document to have a full quality management system during manufacture. However, see quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
Note 2: For guidance on the application of this document, see Annex A.
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 within a risk management process
Note: GB/T 16886.1-2022 Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process (ISO 10993-1:2018, IDT)
ISO 14971 Medical devices- Application of risk management to medical devices
Note: GB/T 42062-2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019, IDT)
ISO 22442-2 Medical devices utilizing animal tissues and their derivatives- Part 2 : Controls on sourcing , collection and handling
Note: GB/T 44353.2-2024 Medical devices utilizing animal tissues and their derivatives - Part 2 : Controls on sourcing, collection and handling (ISO 22442-2 :2020,IDT)
ISO 22442-3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
- IEC Electropedia: available at http://www.electropedia.org/
- ISO Online browsing platform: available at http://www.iso.org/obp
3.1
animal
vertebrate or invertebrate [including amphibian, arthropod (e.g. crustacean), bird, coral, fish, reptile, mollusc and mammal] excluding humans (Homo sapiens)
3.2
cell
smallest organized unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment
3.3
derivative
substance obtained from an animal (3.1) material which is involved directly in the manufacturing process of the medical device or is part of the final medical device
Example: Hyaluronic acid, collagen, gelatine, monoclonal antibodies, chitosan and albumin.
3.4
elimination
removal
process by which the number of transmissible agents is reduced
Note 1: The effectiveness of the process for the elimination of viruses and TSE agents should be expressed mathematically in terms of a reduction factor (see C.2 and YY/T 0771.3-2009, Annex F).
Note 2: Elimination aims to prevent infection or pathogenic reaction caused by transmissible agents.
3.5
inactivation
process by which the ability to cause infection or pathogenic reaction by a transmissible agent is reduced
Note 1: The effectiveness of the process for inactivation of viruses and TSE agents should be expressed mathematically in terms of a reduction factor (see YY/T 0771.3-2009, Annex F).
Note 2: Inactivation aims to prevent infection by, and replication of, transmissible agents.
3.6
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of
—diagnosis, prevention, monitoring, treatment or alleviation of disease,
—diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
—investigation, replacement, modification, or support of the anatomy or of a physiological process,
—supporting or sustaining life,
—control of conception,
—disinfection of medical devices,
—providing information by means of in vitro examination of specimens derived from the human body,
And which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means
Note 1: Products which could be considered to be medical devices in some jurisdictions but not in others include:
—disinfection substances;
—aids for persons with disabilities;
—devices incorporating animal (3.1) and/or human tissues;
—devices for in vitro fertilization or assisted reproduction technologies.
Note 2: The definition of medical devices in the Regulations for the Supervision and Administration of Medical Devices is as follows:
"Medical devices" refers to: any instrument, apparatus, appliance, in-vitro diagnostic reagents and calibrations, materials and other similar or related articles directly or indirectly used in human body, including the software necessary. It achieves its principal action in or on the human body by physical means, rather than by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:
—diagnosis, prevention, monitoring, treatment or alleviation of disease,
—diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
—investigation, replacement, modification, or support of the anatomy or of a physiological process,
—supporting or sustaining life,
—control of conception,
—disinfection of medical devices,
[Source: ISO 13485:2003, 3.7, modified, with Note 2 added]
3.7
non-viable
having no potential for metabolism or multiplication
3.8
technical agreement
binding contract between two or more parties that assigns responsibilities for technical requirements
3.9
tissue
organization of cells (3.2) and/or extra-cellular constituents
3.10
transmissible agents
bacteria, mould, yeast, parasites, viruses, TSE agents and unclassified pathogenic entities
