YY/T 0771.1:2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management English
YY/T 0771 consists of the following parts under the general title Medical devices utilizing animal tissues and their derivatives:
——Part 1: Application of risk management;
——Part 2: Controls on sourcing, collection and handling;
——Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents;
——Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes.
This is Part 1 of YY/T 0771.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
1 Scope
This part of YY/T 0771 specifies, in conjunction with YY/T 0316-2016, a procedure to identify the hazards and hazardous situations associated with medical devices manufactured utilizing materials of animal origin (which are non-viable or have been rendered non-viable), to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
This part 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.
This part does not apply to medical devices utilizing human tissues.
This part does not specify a quality management system for the control of all stages of production of medical devices.
Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in YY/T 0316-2016, and expected medical benefit as compared to available alternatives. This part 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 may apply.
Note 1: It is not a requirement of this part to have a full quality management system during manufacture. However, attention is drawn to YY/T 0287 for quality management systems that control all stages of production or reprocessing of medical devices.
Note 2: For guidance on the application of this part, 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.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1: 2009, IDT)
YY/T 0316-2016 Medical devices - Application of risk management to medical devices (ISO 14971: 2007, IDT)
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives - Part 2:Controls on sourcing, collection and handling (ISO 22442-2: 2015, MOD)
YY/T 0771.3 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 (YY/T 0771.3-2009, ISO 22442-3: 2007, IDT)
3 Terms and definitions
For the purposes of this standard, the terms and definitions established in YY/T 0316-2016 as well as the followings apply.
3.1
animal
any vertebrate or invertebrate [including amphibian, arthropod (e.g. crustacean), bird, coral, fish, reptile, mollusc and mammal] excluding humans
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 material by a manufacturing process
Example: Hyaluronic acid, collagen, gelatine, monoclonal antibodies, chitosan, albumin.
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
Annex A (Informative) Guidance on the application of this part of YY/T 0771
Annex B (Informative) Flowchart of part of the risk management process for medical devices utilizing animal material
Annex C (Normative) Special requirements for some animal materials considering the risk management for TSE agents
Annex D (Informative) Information relevant to the management of TSE risk
Bibliography
YY/T 0771.1:2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management English
YY/T 0771 consists of the following parts under the general title Medical devices utilizing animal tissues and their derivatives:
——Part 1: Application of risk management;
——Part 2: Controls on sourcing, collection and handling;
——Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents;
——Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes.
This is Part 1 of YY/T 0771.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
1 Scope
This part of YY/T 0771 specifies, in conjunction with YY/T 0316-2016, a procedure to identify the hazards and hazardous situations associated with medical devices manufactured utilizing materials of animal origin (which are non-viable or have been rendered non-viable), to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
This part 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.
This part does not apply to medical devices utilizing human tissues.
This part does not specify a quality management system for the control of all stages of production of medical devices.
Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in YY/T 0316-2016, and expected medical benefit as compared to available alternatives. This part 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 may apply.
Note 1: It is not a requirement of this part to have a full quality management system during manufacture. However, attention is drawn to YY/T 0287 for quality management systems that control all stages of production or reprocessing of medical devices.
Note 2: For guidance on the application of this part, 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.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1: 2009, IDT)
YY/T 0316-2016 Medical devices - Application of risk management to medical devices (ISO 14971: 2007, IDT)
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives - Part 2:Controls on sourcing, collection and handling (ISO 22442-2: 2015, MOD)
YY/T 0771.3 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 (YY/T 0771.3-2009, ISO 22442-3: 2007, IDT)
3 Terms and definitions
For the purposes of this standard, the terms and definitions established in YY/T 0316-2016 as well as the followings apply.
3.1
animal
any vertebrate or invertebrate [including amphibian, arthropod (e.g. crustacean), bird, coral, fish, reptile, mollusc and mammal] excluding humans
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 material by a manufacturing process
Example: Hyaluronic acid, collagen, gelatine, monoclonal antibodies, chitosan, albumin.
Contents of YY/T 0771.1-2020
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
Annex A (Informative) Guidance on the application of this part of YY/T 0771
Annex B (Informative) Flowchart of part of the risk management process for medical devices utilizing animal material
Annex C (Normative) Special requirements for some animal materials considering the risk management for TSE agents
Annex D (Informative) Information relevant to the management of TSE risk
Bibliography
