YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling 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 2 of YY/T 0771.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
1 Scope
This part of YY/T 0771 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in YY/T 0771.1-2020.
Note 1: Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management.
This part of YY/T 0771 does not apply to medical devices utilizing human tissues.
This part of YY/T 0771 does not specify a quality management system for the control of all stages of production of medical devices.
It is not a requirement of this part of YY/T 0771 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see YY/T 0287) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part can form a part of a quality management system conforming to YY/T 0287.
Note 2: A general principle for the application of YY/T 0771 is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.
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.
YY/T 0287 Medical devices - Quality management systems - Requirements for regulatory purposes (YY/T 0287-2017, ISO 13485: 2016, IDT)
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1: 2015, MOD)
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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)
YY/T 0771.4 Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes (YY/T 0771.4-2015, ISO/TR 22442-4: 2010, IDT)
3 Terms and definitions
For the purposes of this standard, the terms and definitions established in YY/T 0771.1-2020 as well as the followings apply.
3.1
collection
removal of tissues from animals
3.2
low risk herd
closed herd
herd of bovine animals in which, for at least the previous eight years:
a) there has been documented veterinary monitoring;
b) there has been no case of BSE;
c) there has been no feeding of mammalian-derived protein;
d) there is a fully documented breeding history;
e) there is a fully documented use of veterinary medicines and vaccines;
f) each animal is traceable;
g) genetic material has been introduced only from herds with the same BSE-free status
Note 1: By analogy, low risk herd is applicable to other species naturally affected by TSE. Additional precautionary measures may be required.
3.3
veterinarian
person designated by the relevant competent authority as suitably qualified for the responsibility delegated to him or her relating to ante- and post-mortem inspection of animals and/or relevant certification
Note 2: Under certain jurisdictions, it is a requirement that the veterinarian be a professionally qualified person in veterinary medicine.
Note 3: Under certain jurisdictions, the function of inspection and of certification may be carried out by different individuals. In such cases, the certificate can be signed by a person who is not designated by the competent authority. This function is covered in the quality management system of the medical device manufacturer.
4 General requirements
4.1 General
Apply the requirements of this part as determined by the risk assessment (see YY/T 0771.1-2020).
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Sourcing
6 Collection
7 Handling
8 Storage and transport
Annex A (Normative) Additional requirements for the bovine-sourced materials
A.1 Introduction
A.2 General aspects
A.3 The likelihood of infectivity in the source animals
A.4 The infectivity of the source tissue
A.5 Measures to prevent cross-contamination
Annex B (Informative) Certification and attestation
B.1 Example of a certificate to be issued
B.2 Example of a health attestation to be issued by a veterinarian
Annex C (Informative) Veterinary services
Bibliography
