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GB/T 44353.1-2024Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (English PDF)

动物源医疗器械第1部分：风险管理应用

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

August 23, 2024

Implementation date

September 1, 2025

Scope

GB/T 44353.1-2024 is the English-translated version of 动物源医疗器械第1部分：风险管理应用.

GB/T 44353.1-2024 is the first part of the Chinese standard on medical devices made from animal tissue, and it covers the application of risk management.

Bovine pericardium in a heart valve, porcine intestine in a surgical mesh, bovine collagen in a dermal filler, equine tendon in a graft: these materials do things synthetic ones cannot, and they carry a hazard no synthetic material has, the transmission of a viral or a transmissible spongiform encephalopathy agent from the source animal to the patient.

The risk cannot be tested out of a finished device, so it has to be managed through the whole chain, and this standard sets out how.

It defines the risk management process as it applies to animal-sourced devices: the identification of the hazards arising from the species, the geographical origin, the tissue type and the age of the animal, the estimation and evaluation of the risk, the risk control measures available at sourcing, at collection, in the manufacturing process and in the inactivation and removal steps, the verification of their effectiveness, and the residual risk evaluation and the production and post-production information.

It is aligned with ISO 22442-1. For a manufacturer or a notified body working in China, this is the framework the file is built on.

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Document preview — GB/T 44353.1-2024

National Standard of the People's Republic of China

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

1 Scope
2 Normative references
3 Terms and definitions

Foreword

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.

1 Scope

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 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 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

2 Normative references

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)

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 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)

3.1 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

3.2 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.

3.3 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.

3.4 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.

3.5 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,

3.6 medical device

—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:

—diagnosis, prevention, monitoring, treatment or alleviation of disease,

—diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

3.7 non-viable

having no potential for metabolism or multiplication

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

3.8 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

3.9 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 padding: 6px;

color: rgb(153, 153, 153);

background-color: rgb(248, 248, 248);

border-bottom: 1px solid rgb(153, 153, 153);

GB/T 44353.1-2024 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management (English) Standard No.

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Detail of GB/T 44353.1-2024 Standard No.

Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management Chinese Name 动物源医疗器械第1部分: 风险管理应用

Chinese Classification

Professional Classification GB ICS Classification Issued by SAMR;SAC Issued on 2024-8-23 Implemented on 2025-9-1 Status valid Superseded by Superseded on Abolished on Superseding Language English File Format PDF Word Count 17000 words

Translation Price(USD) 510.0 Keywords

GB/T 44353.1-2024, GB 44353.1-2024, GBT 44353.1-2024, GB/T44353.1-2024, GB/T 44353.1, GB/T44353.1, GB44353.1-2024, GB 44353.1, GB44353.1, GBT44353.1-2024, GBT 44353.1, GBT44353.1

Introduction of GB/T 44353.1-2024

GB/T 44353.1-2024 Medical devices utilizing animal tissues and their derivatives-Part 1 : Application of risk management

3.10 transmissible agents

bacteria, mould, yeast, parasites, viruses, TSE agents and unclassified pathogenic entities

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 10993 · ISO 14971.2019 · ISO 22442

Cited by

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