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YY/T 0340-2009: PDF in English (YYT 0340-2009) YY/T 0340-2009
Implants for surgery.Fundamental principles
ICS 11.040.40
C 30 YY
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0340-2002
Basic principles of surgical implants
2009-12-30 released
2011-06-01 Implementation
Issued by the State Food and Drug Administration
1 Scope
2 Terms and definitions
3 General
4 Special principles concerning design and production...
Appendix A (informative appendix) Relevant regulatory documents
references
Words
This standard is equivalent to ISO /TR U283.20 (M "Basic Principles of Surgical Implants" (English version).
For ease of use, this standard has made the following editorial changes.
a) The term "this technical report" is changed to "this standard";
b) Delete the foreword and introduction of the technical report.
This standard replaces YY/T 0340-2002 "Basic Principles of Surgical Implants", the main changes compared with YY/T 0340-2002
as follows.
-The writing structure was adjusted according to ISO /TR 14283.2004;
-Rewritten some technical content.
Appendix A of this standard is an informative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices (SAC/TC 110).
Drafting organization of this standard. Tianjin Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
The main drafters of this standard. Song Duo, Zhang Chen, Jiao Yongzhe, Jiang Hua.
Basic principles of surgical implants
1 Scope
This standard provides the basic principles for the design and manufacture of active or passive implants to achieve the intended purpose.
2 Terms and definitions
The terms and definitions in column F apply to this standard.
2.J.
Accessory
Not a medical device, but specifically designated by its manufacturer to be used in conjunction with a device to enable the use of the device
Items that achieve the intended purpose of the manufacturer.
2.2
Active medical device
Any medical device that relies on electricity or other energy sources instead of energy directly generated or transformed by the human body or gravity to perform its functions.
Note. Medical devices that transfer energy, substances or other elements between active medical devices and patients without any significant changes are not considered active medical devices.
2.3
Intended purpose
The intended use of the device provided by the manufacturer in the label, instructions and/or promotional materials.
2.4
Labelling
All written, printed or graphical objects
-The label is attached to the medical device or its box or packaging, or
-Supplied with medical equipment
Information about the identification, technical description and use instructions of medical devices, but does not include shipping documents.
Note. Some national or regional regulations regard "label" as "information provided by the manufacturer". [ISO 13485..2003]
2.5
Manufacturer
Manufacturer refers to the natural or legal person responsible for the design, manufacture, packaging and labeling of the device in his own name before entering the market, regardless of this
Whether the operator is himself or a third-party representative.
2.6
Medical device
The manufacturer’s intended use is for human use for the following purposes, whether used alone or in combination, including the use of required software
Any instruments, equipment, utensils, materials or other items of which the purpose is.
-Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
-Diagnosis, monitoring, treatment, alleviation or compensation of disability;
-The study, replacement or regulation of anatomical or physiological processes.
Its main expected effect on the human body surface or in the body is not obtained by pharmacological, immunological or metabolic means, but it may have these effects.
The segment participates and plays a certain supporting role.
Note. ISO 13485.2003 is used for modification.
2.7
Medicinal product
For the purpose of medical diagnosis, to treat or prevent human or animal diseases, or to repair, correct, or adjust the physiological functions of humans or animals
A capable substance or combination of substances.
3 General
3- 1 The design and manufacture of implants should follow the following principles. If the implant is used, any accompanying risks and patient benefits can be weighed.
Acceptable, and can achieve a high level of health and safety protection, they should not endanger the patient under the intended use conditions and when used for the intended purpose
The clinical condition or safety of the product should not endanger the safety and health of users and others (where applicable).
3.2 The method used by the manufacturer for the design and production of the implant should follow the principle of safety, and consider the use of widely recognized process methods.
In order to choose the most suitable method, the manufacturer should follow the following principles.
a) Eliminate or reduce risks as much as possible (safety design and production);
b) Where appropriate, adequate protective measures shall be adopted for the risks involved that cannot be eliminated, and protective measures including alarms may be adopted when necessary;
c) Users should be notified of potential risks caused by the shortcomings of the protective measures used.
3.3 The implant should achieve the performance expected by the manufacturer, and its design, manufacturing and packaging should be adapted to the manufacturer’s requirements mentioned in 3.1.
One or more functions.
3.4 During the life specified by the manufacturer, when the implant is stressed under normal use conditions, its characteristics and performance should still comply with 3.1,
The provisions of 3.2 and 3.3 should not adversely affect the clinical environment, the safety of patients and others.
3.5 Taking into account the instructions and information provided by the manufacturer, the design, manufacturing and packaging of the implant should ensure that the implant is not treated during transportation and storage.
It is expected that the characteristics and performance during use will have a negative impact.
3.6 Considering the expected performance, an acceptable risk should be established for any undesired side effects.
4 Special principles related to design and production
4.1 Chemical, physical and biological properties
4- 1.1 The design and construction of the implant should ensure the features and performance mentioned in Chapter 3 "General Rules". Special attention should be paid to. a) the materials used,
In particular, its toxicity should be considered, and its flammability should also be considered where appropriate;
b) Considering the intended purpose of the implant, the compatibility of its materials with biological tissues, cells and body fluids.
4.1.2 Taking into account the intended purpose of the product, the design, manufacturing and packaging of planters should minimize pollution and residues that affect transportation and storage.
The hazards of personnel and patients involved in storage and use of implants. Particular attention should be paid to the exposed organization and the duration and frequency of exposure.
4.1.3 The design and manufacture of the implant should ensure that the implant is in contact with the materials, substances and gases during normal use or normal operation.
Security. If the planter expects to be used in treatment with medicinal products, its design and manufacturing shall be based on the regulations and restrictions governing medicinal products.
The manufacturing should be compatible with the relevant pharmaceutical products, while maintaining its intended use performance.
4.1.4 If the implant is used in combination with a substance as the main part, and the substance may be considered as specified in 2.7 when used alone
The prescribed medical products, which only play an auxiliary role in the human body compared to implants, should be given the safety, quality and effectiveness of the substance
Verification, while taking into account the intended purpose of the implant.
4.1.5 The design and manufacture of implants should minimize the risk of material leakage..
4.1.6 The design and manufacture of implants should minimize the risk of other substances entering the implant caused by unintentional factors.
Consideration should be given to the natural environment of the plant and its intended use...
4.1.7 The design and manufacture of implants should minimize the risks to patients or users caused by the program and control system (including software).
4.2 Infection and microbial contamination
4.2.1 The design of implants and manufacturing processes should eliminate or reduce the risk of infection to patients, users and third parties as much as possible. its
The design should follow the principle of easy disposal, and when necessary, minimize the patient’s contamination or implantation of the implant during the use of the implant.
Contamination of patients.
4.2.2 Animal-derived tissues should come from animal bodies that are under veterinary control and supervision and are suitable for the organization's intended use.
Information about the regional source of animals is retained by the manufacturer.
The processing, storage, testing and disposal of animal-derived tissues, cells and substances shall provide the best safety guarantee. Especially when it comes to security
All related viruses and other transmissible substances should be eliminated by effective methods, or the viruses should be inactivated in the manufacturing process.
4.2.3 For implants delivered in a sterile state, the design, manufacture and sealing of protective packaging shall provide a microbial barrier to ensure that they are put on the market.
Keep sterile on site and under the storage and transportation conditions specified by the manufacturer until the protective packaging is destroyed or opened.
4.2.4 The manufacturing and sterilization of implants delivered in a sterile state shall use appropriate and confirmed methods.
4.2.5 Implants delivered in a sterile state should be manufactured under appropriate controlled (eg, environmental) conditions.
4.2.6 The packaging system of non-sterile implants should keep the products without deterioration under the specified cleanliness. Implants that need to be sterilized before use
The risk of microbial contamination should be minimized. The packaging system should be adapted to the sterilization method specified by the manufacturer.
4.2.7 The packaging and/or label of the implant should be able to distinguish between the same or similar products under sterile and non-sterile conditions.
4.3 Production and environmental attributes
4.3.1 If the implant is expected to be used in combination with other equipment or instruments, then all the combination including the connection system should be safe, and
The specified performance of the device should not be damaged. Any restrictions on use should be stated on the label or instruction manual.
4.3.2 In the design and manufacture of implants, the following risks should be eliminated or minimized as much as possible.
a) The risk of injury related to physical characteristics including volume/pressure ratio, size, and ergonomic characteristics;
b) Risks related to reasonably foreseeable environmental conditions, such as magnetic fields, external induction, electrostatic discharge, pressure, temperature or pressure, and
Changes in acceleration;
c) The risk of mutual interference with other devices (such as defibrillators or high-frequency surgical devices) normally used for research or specific treatment;
d) The risks caused by the inability to carry out repairs and calibrations shall include.
-Excessive increase in leakage current;
-Aging of materials used;
-Overheating generated by the implant;
-Decrease in the accuracy of any measuring or control device.
4.3.3 The design and manufacture of implants should minimize the risk of fire or explosion under normal and abnormal conditions. "normal
"State and abnormal state risks" refer to those risks determined by risk analysis. Special attention should be paid to those expected for exposure to flammable materials
The last character under the substance or substances that may cause burning.
4.4 Implants with measuring function
4.4.1 The design and manufacturing of implants with measurement functions should be able to provide sufficient accuracy and stability within an appropriate accuracy range.
Sex, while considering the intended purpose of the implant. The accuracy range should be specified by the manufacturer.
4.4.1.1 The design of the measuring method, monitoring and display dials should conform to the principles of ergonomics, and the expected purpose of the implant should be considered.
4.4.1.2 If the implanter or its accessories have instructions for operating the implanter, or display the operation or adjustment parameters through the visual system, this
The information must be easy for users and patients (if necessary) to understand.
4.4.2 The measurement performed by implants with measurement functions shall be expressed in the measurement units specified in the ISO 31 series of standards.
4.5 Radiation protection
4.5.1 General
The design and manufacture of implants should minimize the exposure of patients, users, and other personnel to radiation on the premise of achieving the expected purpose.
Exposure without restricting its application in reaching the prescribed level for therapeutic and diagnostic purposes.
4.5.2 Expected radiation
4.5.2.1 When the implant is designed for special medical purposes and needs to emit harmful radiation, the benefits should be far greater than the wind caused by the harmful radiation itself.
risk. The design and manufacture of this kind of implants should ensure the reproducibility and tolerance of related variable parameters.
4.5.2.2 Implants that are expected to emit potentially hazardous, visible and/or invisible radiation should be equipped with (if feasible) a direct view of these radiations.
Display and/or audible alarm system.
4.5.3 Unexpected radiation
The design and manufacture of implants should minimize the exposure of patients, users or other personnel to unexpected, stray or scattered radiation.
Of exposure.
4.5.4 Instructions
The operating instructions of radiation-emitting implants deal with the nature of the radiation, the protective measures of the patient and the user, and the avoidance of misuse and
The methods to eliminate inherent risks in use are explained in detail.
4.6 Ionizing radiation
4.6.1 The design and manufacture of implants that emit ionizing radiation should be based on the requirements of the intended purpose. If feasible, the radiation dose, geometric conditions and
The radiation quality can be changed and controlled.
4.6.2 The design and manufacture of implants that emit ionizing radiation for the needs of radiological diagnostics should be based on the expected medical purpose.
While the image and (or) output quality, the exposure of patients and users to radiation should be minimized.
4.6.3 The design and manufacture of implants that emit ionizing radiation for the needs of radiotherapy shall ensure reliable supervision and monitoring of radiation doses.
control.
4.7 Principles of connecting or equipping energy implants
4.7.1 General.
4.7.1.1 The design of an implant with an electronic programming system should ensure its reproducibility, accuracy and system performance according to the expected use.
If the (system) risk generated by a special device or system is determined through risk analysis, appropriate methods should be adopted to eliminate or eliminate it as much as possible.
reduce.
4.7.1.2 For implants that rely on internal energy sources to ensure patient safety, there should be a method to determine their energy status.
4.7.1.3 When feasible and appropriate, the implanter should be equipped with a unique code that clearly identifies the implant and its manufacturer (especially for implants).
type). When necessary, the code can be read directly without surgery.
4.7.1.4 For implants that rely on external energy to ensure patient safety, the external energy should have a signal that can signal any energy failure
Alarm system.
4.7.1.5 An external device that monitors one or more clinical parameters of the implant should be equipped with an appropriate alarm system to prompt the use
May lead to death or deterioration of the patient’s health.
4.7.2 Protection against electrical risks
4.7.2.1 Under normal and abnormal conditions, the design and manufacture of implants should try to avoid accidental electrical shocks during the correct installation of implants.
The risk of hitting. "Risks under normal and abnormal conditions" refers to the risks that have been determined through risk analysis of special equipment.
4.7.2.2 The design and manufacture of active implants should minimize the risks related to the use of energy, especially those related to electrical equipment.
Risks related to fouling, leakage and overheating.
4.7.3 Protection against mechanical risks
4.7.3.1 The design and manufacture of implants should protect patients and users from mechanical risks, such as those related to resistance, stability and moving parts.
4.7.3.2 The design and manufacture of the implant should minimize the risk caused by the vibration generated by the implant, unless such vibration is a product specification.
Part of the specified performance, otherwise the vibration should be restricted through technical processes and appropriate means, especially the vibration source.
4.7.3.3 The design and manufacture of implants should minimize the risk of noise, unless such noise is part of the product's specified performance
Otherwise, technology and appropriate measures should be used to reduce noise, especially noise sources.
4.7.3.4 The design and manufacture of terminals and connectors for electric, gas or hydraulic sources and pneumatic sources that need to be operated by users shall be
The possible risks are minimized. •
4.7.4 Protection against risks caused by energy or drugs to patients
4.7.4.1 Taking into account the intended use, the design and manufacture of the implant should ensure that the normal functions of the program and control system (including software) are not endangered
Safety of patients and users.
4.7.4.2 The design and manufacture of energy supply or drug delivery implants should enable the release rate to be set and maintained with sufficient accuracy to make
The risk to the patient is minimized.
4.7.4.3 The administering implant should use appropriate methods to prevent and/or indicate any inappropriate release rate that may lead to risks.
4.7.4.4 Implants for energy supply or drug delivery shall be designed and manufactured in combination with appropriate methods to prevent wind caused by accidental release of energy or drugs.
The risk is minimized.
4.8 Information provided by the manufacturer
4.8.1 Each implant should be accompanied by information on safe use and identification of the manufacturer. At the same time, the user’s training and knowledge should be included.
Knowledge level is taken into account.
The information should include the details on the label and the information on the instruction manual. *
If feasible and applicable, the safe use information of the implant should be indicated on the body of the implant, and (or) on the packaging of each unit or on the product sales.
Indicate on the sales package (when appropriate). If it is not feasible to indicate on the individual packaging of each unit, then one or more
Note on the leaflet provided by the object.
Each planter’s packaging should include instructions for use.
4.8.2 Where appropriate, information should be represented by symbols. Any symbol and identification color used should comply with the standard. There is no current standard,
The meanings of symbols and colors should be indicated on the documents provided by the planters.
4.8.3 The label shall include the following details.
a) Name or trademark and manufacturer's address;
b) The necessary description required by the user to identify the implant and the contents of the package;
c) Where appropriate, instructions that the contents of the package are sterile (eg. "STERILE", "sterile");
h) Special storage and/or delivery conditions;
i) Special operating instructions;
j) Warnings and/or preventive measures taken;
k) For active implants, state the manufacturing year and month;
l) Where appropriate, explain the method of sterilization.
4.8.4 If the intended purpose is not obvious to the user, the manufacturer shall clearly state it on the product label or instruction manual.
4.8.5 Wherever it is reasonable and feasible, implants and detachable parts should be able to be identified by serial numbers or batch numbers so that when the implants and detachable parts are found
Any potential risks in detachable parts can be resolved by all appropriate methods.
4.8.6 Where appropriate, the instruction manual shall contain the following detailed content.
a) Relevant detailed content other than 0, 0, and 10 in Article 4.8.3;
c) For implants that need to be connected to other medical devices or equipment according to the intended purpose, the characteristics of the implant should be explained in sufficient detail, from
And identify the correct implant or device to be used to achieve a safe combination;
d) Prove whether the plant can be used normally and all the information needed for correct and safe operation, and there should be information to determine the energy life when appropriate;
e) Where appropriate, avoid information on the identified risks related to the implantation of the implant;
f) Information on the risks caused by mutual interference caused by the presence of implants during special inspections or treatments;
g) If the aseptic package is damaged, the necessary instructions and a detailed description of the suitable re-sterilization method;
h) For implants sterilized before use, the cleaning and sterilization methods should be explained. At the same time, if the method is implemented correctly, the implants should still follow the
Principles of Chapter 3;
i) A detailed description of any further treatments that must be carried out before the implant is used (such as sterilization, final assembly, etc.);
J) For implants that emit radiation for medical purposes, the nature, type, intensity and distribution of radiation should be specified in detail.
The instructions for use should also include any contraindications and preventive measures taken by the medical staff to briefly describe to the patient. The instruction manual should also
Include the following detailed content;
k) Precautions to be taken if the performance of the implant changes;
l) Preventive measures taken under reasonable and foreseeable environmental conditions, such as magnetic fields, external electrical interference, electrostatic discharge, pressure or pressure
Force changes, acceleration, thermal combustion sources, etc.;
o) The medical products used as component parts and implants should meet the requirements of 4.1.4;
P) Description of the accuracy level of implants with measurement function.
4.9 Clinical evaluation
If the clinical information is used to determine whether the product meets the basic principles of implants, the information should be based on any of the following.
a) A compilation of currently available scientific and technological literature related to the manufacturer's intended purpose;
b) The results of all clinical research conducted in a way that protects the subjects and ensures the scientific nature of the research.
Appendix A
(Informative appendix)
Related regulatory documents
A.1 General
Table A.1 lists ISO /TR 14283.2004 and the current regulatory documents of some countries/regions before September 1,.2003
The relationship between. In addition, some countries not listed in the table have also formulated or are formulating relevant regulations.
This table is intended to show the similarities that exist between reference files. Subject to its scope of application, some provisions of the current national/regional documents
Provisions, especially the terms related to the nature of quality and regulations, may not be mentioned in this standard.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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