YY/T 0771.2-2020Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (English PDF)

Foreword

YY/T 0771 "Medical Devices of Animal Origin" consists of the following parts.

--- Part 1. Risk management applications;

--- Part 2. Control of source, collection and disposal;

--- Part 3. Confirmation of removal and inactivation of viral and transmissible spongiform encephalopathy (TSE) factors;

--- Part 4. Principles for the removal and/or inactivation of factors of transmissible spongiform encephalopathy (TSE) and its process confirmation analysis. This part is part 2 of YY/T 0771.

This section was drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces YY/T 0771.2-2009 "Medical devices of animal origin Part 2. Control of source, collection and disposal", and Compared with YY/T 0771.2-2009, the technical differences are mainly concentrated in "Scope" and "Appendix A". "Appendix B" and "Appendix C" and the previous edition There are no technical differences. In addition to editorial changes, the main technical changes are as follows.

--- Modify the "Scope";

--- Added normative references;

--- Clarify the normatively quoted standards in 4.2 and change "all parts" to "YY/T 0771.1, YY/T 0771.3, YY/T 0771.4 This section ";

--- Modified Appendix A.

This part uses the redrafting method to modify and adopt ISO 22442-2.:2015 "Medical devices of animal origin Part 2. Source, collection and disposal Control. The technical differences between this part and ISO 22442-2.:2015 and the reasons are as follows.

--- With regard to normative quotation documents, this standard has been adjusted with technical differences to adapt to China's technical conditions and adjustments The situation is reflected in Chapter 2 "Regulatory Reference Documents", with specific adjustments as follows.

- Replaced ISO 22442-1.:2015 with YY/T 0771.1-2020 modified to adopt international standards;

- Added references to YY/T 0287, YY/T 0771.3 and YY/T 0771.4.

Introduction

Some medical devices use materials of animal origin.

Animal tissue and its derivatives are used in the design and manufacture of medical devices to provide characteristics that are superior to non-animal matrix materials. Medical device The range of materials and animal-derived materials in the machine is very wide, and these materials can form the main part of the device (such as cattle/porcine heart valves, used in the oral cavity Bone substitutes for hematology or orthopedics, hemostatic devices), coating or infiltration of products (e.g. collagen, gelatin, heparin) or used in device manufacturing processes (e.g.

Animal fat derivatives such as oleate and stearate, fetal bovine serum, enzymes, culture medium).

The sources of tissues and derivatives used in medical devices are generally obtained by the manufacturer from various animals, such as cattle, sheep or commercially available breeding animals Things (including fish). Some professional factories also process animal-derived materials into finished products (such as gelatin), which are used as raw materials for final medical devices.

Meeting the requirements of this part can be regarded as complying with this part of YY/T 0771. The guidelines given in the notes and informative appendix are Material information is not a checklist provided to auditors.

1 Scope

This part of YY/T 0771 specifies the source, collection and disposal of animals and tissues of medical devices made of animal-derived materials The control requirements (including storage and transportation) do not include in vitro diagnostic medical devices. Risk management given in YY/T 0771.1-2020 Process requirements apply.

Note 1. The selection of animal sources is particularly important for the risk management of spreading spongiform encephalopathy (TSE).

This part of YY/T 0771 does not include medical devices that use human tissue.

This part of YY/T 0771 does not specify a quality management system that controls the entire process of medical device production.

YY/T 0771 does not involve the overall quality management system in production, but specifies the requirements for certain elements of the quality management system.

Regarding the quality management system standards that control the entire process of medical device production or reprocessing (see YY/T 0287). Quality management required by this part The system elements can form a part in accordance with YY/T 0287 quality management system.

Note 2. The basic principle of YY/T 0771 application is to give appropriate consideration to the requirements and recommendations in all three partial standards.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For the cited documents without date, the latest version (including all amendments) applies to this document.

YY/T 0287 Medical device quality management system is used for regulatory requirements (YY/T 0287-2017, ISO 13485.:2016 IDT)

YY/T 0771.1-2020 Medical devices of animal origin Part 1. Risk management applications (ISO 22442-1.:2015, MOD)

YY/T 0771.3 Medical Devices of Animal Origin Part 3. Virus and Transmissible Spongiform Encephalopathy (TSE) Factor Removal and Inactivation Confirmation (YY/T 0771.3-2009, ISO 22442-3.:2007, IDT)

YY/T 0771.4 Medical devices of animal origin Part 4. Medical devices of animal origin Part 4. Transmissible spongiform encephalopathy (TSE) Principles for removal and/or inactivation of factors and process confirmation analysis (YY/T 0771.4-2015, ISO /T R22442-4..2010, IDT)

3 Terms and definitions

The terms and definitions defined in YY/T 0771.1-2020 and the following apply to this document.