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YY/T 0771.1-2020

Chinese Standard: 'YY/T 0771.1-2020'
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YY/T 0771.1-2020English519 Add to Cart Days<=6 Medical devices utilizing animal tissues and their derivatives--Part 1: Application of risk management Valid YY/T 0771.1-2020
YY/T 0771.1-2020Chinese24 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House] Valid

   

BASIC DATA
Standard ID YY/T 0771.1-2020 (YY/T0771.1-2020)
Description (Translated English) Medical devices utilizing animal tissues and their derivatives--Part 1: Application of risk management
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.100.20
Word Count Estimation 26,218
Date of Issue 2020-03-31
Date of Implementation 2021-04-01
Drafting Organization Shandong Medical Device Product Quality Inspection Center
Administrative Organization National Medical Device Biological Evaluation Standardization Technical Committee (SAC/TC 248)
Proposing organization State Drug Administration
Issuing agency(ies) National Medical Products Administration

YY/T 0771.1-2020
Medical devices utilizing animal tissues and their derivatives--Part 1. Application of risk management
ICS 11.100.20
C30
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0771.1-2009
Medical devices of animal origin
Part 1. Risk management applications
(ISO 22442-1..2015, MOD)
2020-03-31 release
2021-04-01 Implementation
Issued by the State Drug Administration
Contents
Foreword I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Risk management process 3
Appendix A (informative appendix) Application guide for this part 6
Appendix B (informative appendix) Flow chart of part of the risk management process of medical devices using animal materials 7
Appendix C (Normative Appendix) Particular Requirements for Risk Management of Specific Animal Material TSE Factors 8
Appendix D (Informative Appendix) TSE Risk Management Related Information 12
Reference 20
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 the elimination and inactivation of viral and transmissible spongiform encephalopathy (TSE) factors;
--- Part 4. Principles of elimination and/or inactivation of factors of transmissible spongiform encephalopathy (TSE) and its process confirmation analysis.
This part is part 1 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 0771.1-2009 "Medical Devices of Animal Origin Part 1 Risk Management Application", and YY/T 0771.1-
Compared with.2009, in addition to editorial changes, the main changes are as follows.
--- Revised "Appendix DTSE Risk Management Related Information".
This part uses the redrafting method to modify and adopt ISO 22442-1..2015 "Medical Devices of Animal Origin Part 1. Risk Management
use". The technical differences between this part and ISO 22442-1..2015 and the reasons are as follows.
--- On the normative reference documents, according to GB/T 1.1-2009 and GB/T.20000.2-2009, this part is made technical
The adjustment of the difference to adapt to the technical conditions of our country, the adjustment is concentrated in Chapter 2 "Regulatory Reference Documents", specific
Adjust as follows.
● Replace ISO 10993-1 with GB/T 16886.1 equivalent to international standards;
● Replaced ISO 14971 with YY/T 0316-2016 which is equivalent to adopting international standards;
● Replaced ISO 22442-2..2015 with YY/T 0771.2-2020 which adopted international standards
● Replaced ISO 22442-3 with YY/T 0771.3 equivalent to the international standard.
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Device Biological Evaluation Standardization Technical Committee (SAC/TC248).
This section was drafted. Shandong Medical Device Product Quality Inspection Center.
The main drafters of this section. Liu Chenghu, Shi Yanping, Liu Jia.
The previous versions of the standards replaced by this part are as follows.
--- YY/T 0771.1-2009.
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 properties that are superior to non-animal matrix materials. Medical treatment
The range of materials and types of materials derived from animals in the device is very wide, and these materials can constitute the main part of the device (such as cattle/porcine heart valves,
Osseous or orthopedic bone substitutes, hemostatic devices), product coating or infiltration (e.g. collagen, gelatin, heparin) or used in device manufacturing processes
(Such as animal fat derivatives such as oleate and stearate, fetal bovine serum, enzymes, culture medium).
YY/T 0316-2016 is a general standard that stipulates that manufacturers identify hazards associated with medical devices (including in vitro medical devices)
(Source) and the process of dangerous situations, used to estimate and evaluate these dangerous risks, control these risks and monitor
Effectiveness. This part of YY/T 0771 gives additional requirements and guidelines for evaluating the use of inanimate or inanimate animal organizations
Or medical devices made from derivatives thereof.
This part of YY/T 0771 is expected to cover medical devices including active implanted medical devices (such as implantable infusion pumps).
This part of YY/T 0771 does not apply to in vitro diagnostic devices.
This part of YY/T 0771 is not an "independent" standard and can only be used with YY/T 0316-2016. Application of this part
For guidance, see Appendix A, and for the risk management flowchart of medical devices using animal materials, see Appendix B, TSE factors for specific animal materials
The special requirements for risk management are in accordance with the provisions of Appendix C. For information on TSE risk management, see Appendix D.
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.
Medical devices of animal origin
Part 1. Risk management applications
1 Scope
This part of YY/T 0771 specifies the identification and use of animal-derived materials (inactive or rendered inactive) for medical devices
Equipment-related hazards (sources) and hazardous situations, the estimation, evaluation and control of the resulting risks, and procedures for monitoring the effectiveness of these controls
(Combined with YY/T 0316-2016).
This section applies to medical devices manufactured from animal-derived materials (inactive or rendered inactive), excluding in vitro diagnostic medicine
Therapeutic equipment.
This section does not apply to medical devices that use human tissue.
This section does not specify a quality management system for the control of the entire production stage of medical devices.
In addition, taking into account the residual risk defined in YY/T 0316-2016 and weighing the expected medical comparison with other alternatives
Treatment benefit, this section gives the judgment process of the acceptability of residual risk, as well as medical devices manufactured using animal tissue or its derivatives
Requirements and guidelines for risk management of hazards (sources) .These hazards (sources) include.
a) Bacterial, mold or yeast contamination;
b) virus contamination;
c) Contaminated Spongiform Spongiform Encephalopathy (TSE) factors;
d) Unwanted pyrogenic, immunological or toxicological reactions caused by the material.
Similar principles apply to parasites or other unclassified pathogens.
Note 1. The operation of a comprehensive quality management system during the production process is not a requirement of this part. See the quality management system for the control of all stages of medical device production or reprocessing
For the standard, see YY/T 0287.
Note 2. Refer to Appendix A for application guidance in this section.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
YY/T 0316-2016 Application of medical device risk management to medical devices (ISO 14971..2007, IDT)
YY/T 0771.2-2020 Medical devices of animal origin Part 2. Control of source, collection and disposal (ISO 22442-2..2015,
MOD)
YY/T 0771.3 Medical Devices of Animal Origin Part 3. Virus and Transmissible Spongiform Encephalopathy (TSE) Factor Elimination and Inactivation
Confirmation (YY/T 0771.3-2009, ISO 22442-3..2007, IDT)
3 Terms and definitions
The terms and definitions defined in YY/T 0316-2016 and the following apply to this document.
Related standard:   YY/T 0771.2-2020
Related PDF sample:   YY/T 0616.1-2016  YY/T 0313-2014
   
 
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