Some standard content:
1Cs. 11. 040. 40
Pharmaceutical Industry Standard of the People's Republic of China
YY/T 0340—2002
Implants for surgery
Basic principles
Implants for surgery-Fundamental principles(IS0/RR1283:1995.11)
20020924 Issued
State Food and Drug Administration Issued
200304-01 Implementation
YY/T034C-2002
This standard is equivalent to the standard with international reference TS)/TR,! Implants for surgery-Basic principles (English version)
The appendix of this standard is a collection of data. For the purpose of using this standard, please refer to the Chinese version and the accompanying Chinese version of the first edition! Corresponding changes have been made to the regulations and standards in this standard catalog, and the current standards and standards of my country and the United States have been added. This standard is based on the National Medical Products Administration, the International Medical Device Standardization Committee and the New Medical Device Standardization Committee (TCII-Technical Standard Drafting Unit: Home. The drafting unit is the European Medical Department, the Ministry of Health, the Ministry of Quality Supervision, Inspection and Quarantine, and the Ministry of Health. Scope
Basic principles of surgical implants
This standard defines the principles of design and manufacturing of active or active implants to achieve the expected date.
Medical devices medicalrlevice
YY/T034D—7002
Daily production of this design is the following days of use! No matter it is used alone or in combination, including the required software, no matter what device is used, no matter it is used alone or in combination, no matter it is used with other items, these are: diagnosis, prevention, clinical care, treatment or diagnosis of short-term transmission, treatment, level of understanding or compensation: the human body age or physiological excess, check the age or image of the human body or the human body is not the main expected deduction of the human body, the free learning step of the device is obtained, but it can be used with this period of participation and play an auxiliary function.
active medical device activeniedical Any medical device that is made of electricity or other sources, which does not directly generate energy from human body or earth, and does not convert energy into energy directly from them, and does not recognize any other active medical device without any change in quality or other elements. The following are the steps of active medical devices:
implnntubleduvice
used for medical needs:
all are introduced into the human body
on the surface of the support,
applicable to surgical insertion methods, and the above-mentioned devices are reduced in five operations. Only artificial Reach, before the human body retention rate of small 3 large organs, recognized as a person:
medical product medieinalproduei
use to prevent human and animal diseases of the substance or combination of substances: for medical diagnosis of the day for human, animal: used to develop, correct, adjust the physiological function of human or animal substances or combination of substances also recognized as social therapeutic products
expected month intenderdpnrpase
need to reach the disease quickly! Manufacturers in the label noise book, Bili Te village material provided data requirements. 1
YY/T G340—2007
Manufacturer
The person or legal person responsible for the design, manufacture, packaging and labeling of a device before it is put on the market, whether or not he is the representative of another party.
Accessory
A part specially designed by the manufacturer of a single device and used together with the device to ensure that the device can meet the manufacturer's deadlines.
Label
) Mark on the medical device or its box or packaging, and on the relevant written, printed or printed materials on the medical device, and its contents shall include the identification, instructions and instructions for use of the medical device, and shall not include the "documentary"
3 Planning
3.1 The design and manufacturing of implants must comply with the principles of enterprise and health assurance in order to achieve their current status and not damage the environmental conditions or the safety of the patient when used under various conditions, and not increase or damage the safety of the user or others. In this regard, any risks associated with the use of implants can be accepted if a high level of health safety protection can be avoided. 3 .? The manufacturer shall analyze the methods used in the production of implants and shall follow the principles of safety and consider the most practical methods. The manufacturer shall follow the following principles: a) Eliminate or reduce risks as much as possible (safety design and production): b! For risks that cannot be eliminated, take adequate protective measures, including carbon monoxide protection if necessary: e) The potential risks arising from the protective measures shall be fully considered by the user during the manufacturing process, and the design, manufacturing and other costs shall be in accordance with the relevant manufacturing regulations:
t||3.4 In the early stage of manufacturing: when the product is under normal conditions, the characteristics and performance of the product should still meet the requirements of 3.1, 3.2 and 3.3, while the environmental conditions should be small, and the safety of the product and others should not be affected. 3.5 The design and manufacturing of the product should not have a negative impact on the product and the safety of others during the expected period of use. When considering the expected performance, an acceptable risk reduction limit should be established for the effects that are not expected to occur in the product. 4 Special principles for design and production
4.1 Chemical and biological properties
4.1.1 Related substances The design and manufacture of the device should ensure the maximum performance and performance of the device mentioned in the "General Principles". The device should be designed and manufactured to the maximum extent possible. The device should be guided and noted that: a) The device should be used for a specific purpose and should be inspected and identified. At the same time, its irritability should also be considered: b) The intended use of the device should be considered. The materials and components of the device should be considered. 4.1. The device should be designed and manufactured to minimize the risk of any damage to the human body during its return, treatment and export. In particular, the device should be designed to minimize the risk of any damage to the human body during its direct contact with the tissue. The device should also be designed to minimize the risk of any damage to the human body during its direct contact with the tissue. /0340-202
4.1.3 The design and manufacture of the equipment shall demonstrate the safety of the sealants, materials and gases with which it comes into contact during use or operation. Equipment used as multi-functional medical products shall have their design and manufacture consistent with the precautions and safeguards and expected performance of the medical product:
4.1.4 If the ten items of equipment are used separately, as described in 2., they are considered medical products. In general, these methods are only temporarily useful. The safety, quality and time-limited effects on the human body should be verified according to the expected date of the implant. 4.1.5 The design and manufacture of the implant should be tailored to the intended use environment and minimize the risks of other factors. 4.1.6 The design and manufacture of the implant should be tailored to the intended use environment and minimize the risks of other factors caused by unintended factors. 1.7 The design and manufacture of the implant should be designed to minimize the risks to patients and users, including the system and software.
4.2 Infection and microbial contamination
4.2.1 The manufacturing process of the implant should eliminate or minimize the risks to patients and users as much as possible, and the risks to users and users should be fully followed. The effects of the implant on patients should be minimized during the use period.
4.2.2 Precautions for the use of non-animal-derived materials should be strictly controlled. Information on the source of the materials should be kept by the manufacturer, the manufacturer, and the materials. Quality control, isolation, and rectification should pay attention to the safety of the product. Effective methods should be used to eliminate the virus and its transmissible substances involved in the safety. 4.2.3 The virus should be sterilized in the production process. The design, manufacture and sealing of the blood-proof packaging should be confirmed as soon as possible. To ensure that the microorganisms can survive under the manufacturer's specified safety plan when the product is put into use, the packaging should be opened, and the product should be sterilized in an effective way. 4.2.4 The sterilization measures should be taken temporarily and the results should be confirmed. 4.2.5 The product should be produced under appropriate control conditions such as: > environment. 4.2.6 The packaging of non-sterile implants should be kept clean at a specified level and the product should not deteriorate; the implants need to be sterilized before they are out of use. The risk of biological contamination should be low: the packaging should be manufactured using the specified sterilization method. 4.2.7 The packaging and/or labeling of the implants should be distinguished from similar products manufactured under non-fire conditions. 4.3 Production and environmental considerations
1.3.1 If the implant is used in conjunction with other devices, its entire system should be adequately safe and cannot be reported outside the thermal performance of the device: any use restrictions should be within the specified period of time. 43.2 The design and manufacture of the implants should be able to eliminate or exceed the following risks: a) Risk of injury to the rock, including the ratio of volume to pressure, size and ergonomics; h; Risk of environmental factors such as magnetic field, external electric field, pressure, temperature and atmospheric pressure;
Risk of interference with other devices (drug release device or high frequency surgical device) when used in the treatment belt: :) t
) Risk of failure to maintain and collect the shell. Including: excessive flow of data. Use of materials, overheating of the product, reduction of the accuracy of the metering machine control 4.3.3 The manufacturer of the protective equipment shall determine the risk of failure or loss of the needle under normal and abnormal use conditions, normal conditions and abnormal belt system wind risk. It should be noted that the most important thing to note is that the equipment should be used with caution in the presence of sensitive materials or materials that may cause explosions. 4.4.1 The equipment with the function of viewing the environment should be tested and tested according to the requirements of the equipment. The equipment should be able to play a sufficient role in the expansion limit according to the equipment's performance. The degree of resistance should be determined by the equipment manufacturer. 4.4.1. The equipment should be tested and tested according to the requirements of the equipment. The equipment should be tested and tested according to the requirements of the equipment. 03432002
4.4.1.2 When the person is suitable for the visual system, the user must be able to understand the user when necessary.
1.4.2 The model with the measurement disk and the virtual model shall adopt the measurement units specified in the 1S031 system standard: 4.5 Radiation protection
4.5.1 The design and manufacture of the implant shall be carried out in accordance with the requirements of the standard. The radiation on the patient shall be minimized, and the influence of the patient on others shall be limited to the treatment and diagnosis level specified in the standard. 5.2 Anticipated Radiation
4.5.2.1 When the design and construction of the missile are to provide good radiation protection for the intended target, the benefits to be gained shall be demonstrated to outweigh the risks posed by the zero thrust missile, and the design and construction shall ensure the quality and reliability of the missile. 1.52.2 When potential hazards are present, visible and/or invisible warning systems shall be provided to ensure that they are practicable:
4.5.3 Non-periodic Radiation
Whether the vehicle is designed and constructed to minimize the risk of unexpected, dispersed or stray radiation exposure, or to minimize the risk of unintended, scattered or misplaced radiation exposure.
4.5.4 Explanation
The nature of the radiation to be emitted, the protection of the device against the use of the device, and the methods to avoid wrong use and eliminate the dangers in the process shall be given. 4.6 Radiological
4.6.1 The design of the implantable device for ionizing radiation can be made according to the requirements of the test period, ensuring the quality of the device and the control of the device.
4.6.2 The device for diagnosing radiation should be manufactured according to the requirements of the test period, and the radiation to the patient and the white matter layer should be obtained according to the medical data, and the radiation to the patient and the reuse of the device should be minimized as much as possible. 4.3 The design and manufacture of cabinets that emit ionizing radiation for the purpose of radiation therapy shall ensure the reliability of the equipment and the control of the equipment. 4.7 Energy sources or energy sources connected to the equipment 4.7.1 The design of the equipment with self-contained cumulative current shall ensure the reproducibility, non-dripability and energy efficiency of the system. Appropriate measures shall be taken to eliminate or reduce the risks determined by the risk analysis of these equipment or systems. 4.7.2 When the safety of the equipment is based on internal power sources, there shall be a method to determine the power supply. 4.7.3 If necessary and appropriate, the equipment shall be clearly distinguished: the type of equipment and its manufacturing age; if necessary, the equipment can be connected without any external materials. 4.7.4 Some alarm systems which have the ability to send a small signal due to power failure of the external source other than the external electrical safety device.
4.7.5 For implanted persons, an external device shall be equipped with an appropriate alarm system to indicate a situation which could result in death or deterioration of the health of the user. 4.7.6 Protection against electrical risks
4.7.5: "Under normal use and abnormal use conditions, the design and manufacture of implants shall avoid the risk of accidental thermal shock as much as possible during implantation. "Normal and restored use conditions" refers to the risks determined through risk analysis of the device, 1.7.6.2 Active devices: Reduce safety risks by using energy sources. Avoid electrical hazards related to the use of natural gas, overheating and other electrical hazards.
4.7 Protection against mechanical risks
4.7.7.1 The design and manufacture of implants shall protect the user from mechanical risks: for example, force, strength, and displacement. 1.7.7.2 The design and manufacture of implants shall protect the user from mechanical risks: for example, force, strength, and displacement. The risk of particulate matter generating vibrations should be reduced to a minimum, unless this vibration is part of the specified performance of the product. Otherwise, it should be limited by appropriate technical processes, especially sufficient sources. YY/T0340—2002
4.7.7.3 The design and manufacture of implants should minimize the risk caused by the straw. Unless this vibration is part of the specified performance of the product, it should be limited by appropriate technical processes and appropriate systems, especially sufficient sources. 4.7.7.4 (Heat source, gas source, micro-pressure source and air pressure source) The design and manufacture of the terminals and connectors should minimize the risk of all risks caused by the filter user.
47.8 Protection of magnetic materials from skin damage 4.7.8.1 Design and manufacture of implants . The proper function of the bed and control system (including software) should be ensured not to endanger the safety of the user.
4.7.3.2 The design and manufacturing of the special function or the second drug should be such that its release rate and maintenance can be achieved to minimize the risk of product damage.
4.7.8.3 The design and manufacturing point of the person should use appropriate methods to protect the person and/or any inappropriate process efficiency that can reduce the risk.
4.7.6.4 The technology, design and manufacturing seat of the enzyme replacement should be combined with the current method to reduce the risk caused by the special function or drug to a minimum.
4.8 Information to be provided by the manufacturer
4.8.1 A person should be accompanied by a safety manual and a dosage form. The user's level of knowledge and environment should also be included in the product description. The detailed instructions for use and instructions for use should be included in the product description. The safe use instructions should be on the product itself and/or on each product packaging, or on the outside of the product. If it is not feasible to include all instructions on a single product packaging, then one or more instructions should be provided. Note: The instructions for use should be included in each product packaging. 4.8. For example, if the light code is used, the total fiber code used should match the standard. If there is no filter code, the code should be in the user's name. 4.8.3 The label should also include a detailed list of contents. Manufacturer's trademark address;
above) constant use of factors to confirm the implant and package contents required for the cat description! :) packaging content for the south of the description: "KE" at the end of ") use of the Ya confirmed tight other interference or system code, \" or "\"; implant person use effective period T;
E; relevant person state drug said;
special said limit (such as: \customized\ or \instrument for clinical research\): h special promotion! or change of inch conditions!
) special operating instructions;
marketing notice or special:
k Liu Riyuan protection person. Instructions Year of manufacture: 1) If necessary, explain the method of destruction of the function
4.8.4 If the user cannot achieve the expected month-the manufacturer shall clearly state the above-mentioned product name or individual month. 4.8.5 For its rationality and operability, the rate of characters and parts shall be able to be listed or approved. If the character and or part is found to be new, the method of retrieval is adopted. Jiang He Yu Feng Yuan 4.8.6 The use description shall include the following rate system tolerance: 1) 4.8.3.3 Except for d),,, and k>, the following are detailed in the text: 1) 3.3 System and performance and mission requirements; 5
YYT0340-7302
Technical requirements for the period of use of other medical devices or equipment; In order to achieve the safety of the equipment, the combination of the dose and the device must be used to the fullest extent possible; All instructions should state the applicability of the device and the safety requirements, and at the same time should state the life span of the device: the confirmed risk avoidance period related to the implant, the risks caused by the presence of implants in special inspections or treatment periods, the necessary instructions for the immediate sterilization of the packaging, and the implementation of the sterilization method: For the implants that have been used before, the relevant sterilization methods should be clearly stated: Attached, this file should avoid the third Beijing training: 1)
Implant Before use, the person must read the description of the intended use (planning, development, distribution, etc.); for medical purposes, the person must explain the radioactivity, distribution, etc. The instructions for use should also include the age, health care personnel and the general precautions that should be discussed and explained in detail; k) Precautions for use when using the implant: 1) Information about the properties of the implant: the effects of environmental conditions (field of view, external electrostatic effects, pressure or force changes, speed, fire sources, etc.); 2) Information about the drugs and products provided to the user: including any limitations on the selection of materials; 3) Precautions to avoid risks that are different from normal risks, and to ensure that the product meets the requirements of 4.1. 4.2. The description of the actual performance of the implant: 4.9 Clinical evaluation
These are the basic principles for judging whether the product is suitable for human control based on the clinical results in the next few periods of time. The production efficiency as described in Article 3.6 should be based on the following ten indicators:
a! A few feasible and relevant scientific and technological documents are summarized: b) The results of the clinical research conducted by the Ministry of Finance to ensure the scientific nature of the technical report, Appendix A
《Informative Appendix）
Related regulatory documentswwW.bzxz.Net
YY/T03402002
The following references list the regulatory documents related to this standard and the current national/regional regulatory documents from 1944 (relevant to the regulatory documents before the time of this technical document). In addition, none of the countries listed in this index have also formulated or are in the process of formulating relevant regulations.
This index is intended to refer to the most recent reference documents that are currently in force. Subject to the limitations of the country of use, other items of the relevant national/regional documents that are in force are supported by the relevant departments, and the quality and legal provisions of wood are described in this standard.
European Community||tt| |1;1!93 gold 14/42/EEC Council Directive on the classification of medical devices; 93/42/EEC Directive on therapeutic devices; 12 July 1993, Vol. 36, item 169 2) 90/385/HF Council Directive of 20 June 1990 on the classification of active medical devices; 1990 July 201, Vol. 23 189th U.S. Food, Drug, and Cosmetic Regulation Act, promulgated in 2013: Section 510: Regulation and licensing of device products, especially Section 513: Classification as medical devices, Section 515: Market entry, Section 520: General control of medical devices, Article 1 of the ACFR, Section 801: Part 1: Standards Part 2: Market Access Part 3: Market Access Part 4: Market Access Part 5: Current Good Manufacturing Practice (MP) Part 10: Radiological Health (Overview) Part 10:1 Performance Standards for Products Emitting Ionizing Radiation Part 10:2000) Regulations on the Administration of Medical Devices The Regulations on the Administration of Medical Devices came into effect in April 2001, and the Food and Drug Law of the People's Republic of China (MIR) Medical Device Regulations
(S refers to Chapter 3 of the Medical Device Regulations on Special Needles Implantable Devices)\M""M\Fifth part of the purchase guide
2) CGM's revision of the version of the technology on November 2, 1521, the federal government allowed the two listed in the six records: a medical doctor needs to pull the biocompatible rate; a medical consultation plan is written on the label, and the two documents are executed together with the user's "Buying Device General Information and Radiological Health Center" and the \Evaluation and Research Center" industry,
YY:T 0340—2002
\CANCSA\AN/CSA 12.2 Ao6OI.1 M95 Appendix B
"Material Contamination?
Dream Examination Book Division
B.1 The following standards give the requirements for implant products that are linked to these basic principles: 157166-12? Surgery - War requirements [S(1-7C8-1:2030 External implants - Active medical devices - Part 1; Safety, marking or use of general requirements
YY (.G132002 General technical conditions for surgical implants YY××× General technical conditions for long-body implants (under preparation).? For guidance on risk analysis of the use of prudent substances, see the following documents EN_441. Medical devices - Risk analysis
YY Jiang 1315-2U Medical risk intelligence ear Part 1: Risk analysis of the original state 11 years 113 before, in the enjoyment of the year Chapter 7 ten, 19% year 113H Yue: /PC199463 United full telegram, the Ministry of National Electronics 2.-Fang Zhengxu Management, 222N1-on [do: this same,14/42/EEC of 1935 on the classification of medical devices; Directive 93/42/EEC on therapeutic devices; Directive 93/42/EEC of 12 July 1993, Vol. 36, No. 169; 2) Directive 90/385/HF of 20 June 1990 on the classification of active medical devices; Directive 90/385/HF of 20 July 1990, Vol. 23, No. 18 9 US Food, Drug, and Cosmetic Regulation Acts promulgated in 2013: Section 510: Device Product Licensing and Registration, especially Section 513: Classification as Medical Devices, Section 515: Market Access, Section 520: General Control of Medical Devices, Article 11: Electronic Products, ACFR, Federal Regulations, Section 801: Part 1: Standards Part 2: Market Access Part 3: Market Access Part 4: Market Access Part 5: Current Good Manufacturing Practice (MP) Part 10: Radiological Health (Overview) Part 10:1 Performance Standards for Products Emitting Ionizing Radiation Part 10:2000) Regulations on the Administration of Medical Devices The Regulations on the Administration of Medical Devices came into effect in April 2001, and the Food and Drug Law of the People's Republic of China (MIR) Regulations on Medical Devices (referring to Chapter 3 of the Regulations on Medical Devices, which stipulates that a person has a special need for implanting a device that uses a special purpose) \M" "M\ The fifth part of the regulations stipulates that from November 2, 1521 to November 2, 1521, the federal government has issued two documents, namely, "Medical Devices and Radiological Health Centers" and "Evaluation and Research Centers" for users, which are implemented together with the industry,
YY:T 0340-2002
\CANCSA\AN/CSA 12.2 Ao6OI.1 M95 Appendix B
"Material Contamination"
Dream Test Book Division
B.1 The following standards give the requirements for implant products in connection with these basic principles: 157166-12? Allied Surgery - Warfare Requirements [S(1-7C8-1:2030 External Implants - Active Therapeutic Devices - Part 1; Safety, Labeling or Use - General Requirements
YY(.G132002 General Technical Conditions for Allied Surgery Implants Document YY××× General Technical Conditions for Long Body Photography (under preparation).? For the risk analysis guide for the use of prudent substances, please refer to the following documents EN_441. Medical Device Alkali - Risk Analysis || tt || YY Jiang 1315-2U Medical Risk Intelligence Part 1: Risk Analysis of the Original State 11 years 113 years ago, the electricity in the enjoyment of the people in the year Chapter 7 ten, 19% year 113H Yue: / PC199463 United full telegram, the Ministry of National Electronics reached 2.- Fang Zhengxu Management, 222N1- on [Do: This is the same,14/42/EEC of 1935 on the classification of medical devices; Directive 93/42/EEC on therapeutic devices; Directive 93/42/EEC of 12 July 1993, Vol. 36, No. 169; 2) Directive 90/385/HF of 20 June 1990 on the classification of active medical devices; Directive 90/385/HF of 20 July 1990, Vol. 23, No. 18 9 US Food, Drug, and Cosmetic Regulation Acts promulgated in 2013: Section 510: Device Product Licensing and Registration, especially Section 513: Classification as Medical Devices, Section 515: Market Access, Section 520: General Control of Medical Devices, Article 11: Electronic Products, ACFR, Federal Regulations, Section 801: Part 1: Standards Part 2: Market Access Part 3: Market Access Part 4: Market Access Part 5: Current Good Manufacturing Practice (MP) Part 10: Radiological Health (Overview) Part 10:1 Performance Standards for Products Emitting Ionizing Radiation Part 10:2000) Regulations on the Administration of Medical Devices The Regulations on the Administration of Medical Devices came into effect in April 2001, and the Food and Drug Law of the People's Republic of China (MIR) Regulations on Medical Devices (referring to Chapter 3 of the Regulations on Medical Devices, which stipulates that a person has a special need for implanting a device that uses a special purpose) \M" "M\ The fifth part of the regulations stipulates that from November 2, 1521 to November 2, 1521, the federal government has issued two documents, namely, "Medical Devices and Radiological Health Centers" and "Evaluation and Research Centers" for users, which are implemented together with the industry,
YY:T 0340-2002
\CANCSA\AN/CSA 12.2 Ao6OI.1 M95 Appendix B
"Material Contamination"
Dream Test Book Division
B.1 The following standards give the requirements for implant products in connection with these basic principles: 157166-12? Allied Surgery - Warfare Requirements [S(1-7C8-1:2030 External Implants - Active Therapeutic Devices - Part 1; Safety, Labeling or Use - General Requirements
YY(.G132002 General Technical Conditions for Allied Surgery Implants Document YY××× General Technical Conditions for Long Body Photography (under preparation).? For the risk analysis guide for the use of prudent substances, please refer to the following documents EN_441. Medical Device Alkali - Risk Analysis || tt || YY Jiang 1315-2U Medical Risk Intelligence Part 1: Risk Analysis of the Original State 11 years 113 years ago, the electricity in the enjoyment of the people in the year Chapter 7 ten, 19% year 113H Yue: / PC199463 United full telegram, the Ministry of National Electronics reached 2.- Fang Zhengxu Management, 222N1- on [Do: This is the same,
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