YY/T 0640-2016 (YYT0640-2016)

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YY/T 0640-2016
Non-active surgical implants - General requirements
ICS 11.040.40
C45
People 's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0640-2008
General requirements for passive surgical implants
(ISO 14630..2012, IDT)
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 range 1
2 normative reference document 1
3 Terms and definitions 2
4 Expected performance 3
5 design attributes 3
Material 4
Design Evaluation 4
8 manufacturing 5
9 sterilization 6
10 Packing 6
11 Information provided by the manufacturer 7
Reference 10
Preface
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0640-2008 "General requirements for passive surgical implants", which is significantly different from YY/T 0640-2008
Different.
- to modify the scope of application of the standard, which does not apply to implants derived from viable animal tissues;
- the terms and definitions of the "magnetic resonance environment" (see 3.4) and "magnetic resonance imaging" (see 3.5);
- add part of the design attribute [see Chapter 5 f), s), t), u), v)];
- more detailed provisions on "preclinical evaluation" (see 7.2), "clinical evaluation" (see 7.3) and "post-marketing follow-up" (see 7.4);
- the contents of the "operating instructions" made more detailed provisions [see 11.3a), t), u)];
--- delete the.2008 edition of Appendix A "and ISO /T R14283 outlined by the basic principles of the corresponding relationship" content.
This standard uses the translation method equivalent to ISO 14630..2012 "General requirements for passive surgical implants".
And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows.
GB/T 7408-2005 Data and exchange format Information exchange date and time representation (ISO 8601..2000, IDT)
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
(ISO 10993-1..2009, IDT)
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residues (ISO 10993-7.
1995, IDT)
GB/T.19974-2005 Characteristics of sterilization factor for medical care products and setting of sterilization process for medical devices, confirmation
And general requirements for routine control (ISO 14937..2000, IDT)
YY/T 0297-1997 Clinical investigation of medical devices (ISO 14155..1996, IDT)
--- YY 0970-2013 Disposable use of animal-derived materials Sterilization of sterilized liquid sterilizers for medical devices
Conventional control (ISO 14160..1998, IDT)
- YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971..2007, IDT)
- YY/T 0567.1-2013 Sterile processing of health care products - Part 1. General requirements (ISO 13408-1..2008,
IDT)
--- YY/T 0802-2010 Medical Device Sterilization Manufacturer Provides information on disposable sterile medical devices
(ISO 17664..2004, IDT)
- YY/T 0771.1-2009 Animal source medical device - Part 1. Risk management applications (ISO 22442-1..2007, IDT)
- YY/T 0771.2-2009 Animal source medical devices - Part 2. Control of sources, collection and disposal (ISO 22442-2.
2007, IDT)
- YY/T 0771.3-2009 Animal source medical device - Part 3. Virus and transmissible spongiform encephalopathy (TSE) factor
In addition to confirmation of inactivation (ISO 22442-3..2007, IDT)
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110).
The drafting of this standard unit. Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration medical equipment technical review
Assessment center.
The main drafters of this standard. Ma Chunbao, Li Jia, Li Libin, Qi Baofen, Liu Bin, Min Yue, Sun Jiayi.
This standard replaced the previous version of the standard release.
--- YY/T 0640-2008.
introduction
This standard provides a method for the treatment of the basic principles of passive surgical implants in ISO /T R14283,
The method of basic provisions relating to medical devices in Appendix 1 of the European Council Directive 93/42/EEC of 14 June, as they apply
In passive surgical implants, hereinafter referred to as implants. This standard may also be of a benefit to the manufacturer's compliance with other regulatory requirements.
The criteria for passive surgical implants and related devices are divided into three grades. The standard grade involved in the implant itself is shown below
(One level is the highest).
- Level 1. General requirements for passive surgical implants;
- Level 2. special requirements for all types of passive surgical implants;
--- Level 3. Special requirements for various passive surgical implants.
A standard, such as this standard and reference [9], which contains requirements for all passive surgical implants,
Two, three standard there are some additional requirements.
The secondary criteria (see references [1], [7], [11], [14] and [25]) apply to more limited categories of passive surgical implants,
Some implants designed for neurosurgery, cardiovascular surgery, or joint replacement.
The three criteria (see references [3], [8], [12] and [13]) apply to specific implants in certain types of passive surgical implants, such as
Hip prosthesis or arterial stent.
To understand all the requirements of a particular implant, it should be consulted from the current minimum level of the standard.
Note. The requirements in this standard are in line with international consensus. Individual or national standards or regulatory authorities may require other requirements.
General requirements for passive surgical implants
1 Scope
This standard specifies the general requirements for passive surgical implants (hereinafter referred to as implants). This standard does not apply to dental implants, dental
Repair materials, dental pulp implants, intraocular lenses and implants of active animal tissue.
In the case of safety, this standard specifies the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and manufacturer
Information requirements, and validation of tests that meet these requirements.
Other tests are given in the secondary and tertiary standards.
Note. This standard does not require the quality management system of the implant manufacturer, but if the manufacturer has a quality management system in accordance with ISO 13485,
To ensure that the expected performance of the implant will play a significant role in helping.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
ISO 8601 Data storage and exchange forms Information exchange date and time representation (Dataelementsandinterchange
formats-Informationinterchange-Representationofdatesandtimes)
ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (Biologicalevalua-
tionofmedicaldevices-Part 1. Evaluationandtestingwithinariskmanagementprocess)
ISO 10993-7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residues (Biologicalevaluationof
medicaldevices-Part 7. Ethyleneoxidesterilizationresiduals)
ISO 11135-1 Sterilization of sterile ethylene glycol for medical care products - Part 1. Development, validation and validation of sterilization of medical devices
The requirements for routine control (Sterilization ofhealthcareproducts-Ethyleneoxide-Part 1. Requirementsforde-
velopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)
ISO 11137-1 Sterilization of sterilization products for medical care products - Part 1. Development, validation and routine of sterilization of medical devices
Control requirements (Sterilization ofhealthcare products-Radiation-Part 1. Requirementsfordevelopment,
validationandroutinecontrolofasterilizationprocessformedicaldevices)
ISO 11137-2 Sterilization of sterilization products for health care products - Part 2. Establishment of sterilization dose (Sterilization ofhealth
careproducts-Radiation-Part 2. constructedthesterilizationdose
ISO 11607-1 Packaging of final sterilized medical devices - Part 1. Materials, sterile barrier systems and packaging system requirements (Packa-
gingforterminalysterilizedmedicaldevices-Part 1. Requirementsformaterials, sterilebarriersys-
temsandpackagingsystems)
ISO 13408-1 Sterile processing of health care products - Part 1. General requirements (Asepticprocessingofhealthcare
products-Part 1. Generalrequirements)
ISO 14155 Human medical devices Clinical trials Clinical trials Quality management practices (Clinicalinvestigationofmedical
devicesforhumansubjects-Goodclinicalpractice)
ISO 14160 Health care products Sterilization Use of animal tissues and their derivatives for disposable use Liquid chemical treatment of medical devices
Bacteriostatic medical device Sterilization process Characterization, development, validation and routine control requirements (Sterilization ofhealthcare products-
Liquidchemicalsterilizingagentsforsingle-usemedicaldevicesutilizinganimaltissuesandtheirderiv-
atives-Requirementsforcharacterization, development, validationandroutinecontrolofasterilization
processformedicaldevices
ISO 14937 Characteristics of sterilization and sterilization factors for health care products and setting, validation and routine control of sterilization of medical devices
General requirements (Sterilization ofhealthcareproducts-Generalrequirementsforcharacterization ofasterili-
zingagentandthedevelopment, validationandroutinecontrolofasterilizationprocessformedicalde-
vices
ISO 14971 Medical Device Risk Management The use of medical devices (Medicaldevices-Application ofriskman-
agementtomedicaldevices
ISO 17664 Sterilizers for medical devices provide information on disposable sterile medical devices (Sterilizationof
medicaldevices-informationtobeprovidedbythemanufacturerfortheprocessingofresterilizable
medicaldevices
ISO 17665-1 Sterilization of medical and health care products - Part 1. Development, validation and routine of sterilization of medical devices
Control requirements (Sterilization ofhealthcareproducts-Moistheat-Part 1. Requirementsforthedvelop-
ment, validationandroutinecontrolofasterilizationprocessformedicaldevices)
ISO 22442-1 Medical devices using animal tissues and their derivatives - Part 1. Application of risk management (Medicaldevices
usinganimaltissuesandtheirderivatives-Part 1. Applicationofriskmanagement
ISO 22442-2 Medical devices using animal tissues and their derivatives - Part 2. Control of sources, collection and disposal
(Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part 2. Controlsonsourcing, colection
andhandling
ISO 22442-3 Medical devices using animal tissues and their derivatives - Part 3. Virus and transmissible spongiform encephalopathy (TSE)
Factor removal and inactivation [Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part 3. Valida-
tionoftheelimination and/orinactivationofvirusesandtransmissiblespongiformencephalopathy
(TSE) agents]
ISO 80000 (all parts) quantities and units (Quantitiesandunits)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Coating
A layer of material for covering or partially covering the surface of the implant.
3.2
Implantable state implantablestate
It is ready for implantable human implant status.
3.3
Leakage
Including liquid, including body fluids, into or out of the implant.
Note. For example, unexpected diffusion phenomenon.
3.4
Magnetic resonance environment (MR environment) magneticresonanceenvironment (MRenvironment)
MR system in the 0.5mT (5G) line of space, including the MR scanner around the entire three-dimensional space.
Note. When the 0.5 mT line is included in the Faraday cage, the entire space should be considered as a magnetic resonance (MR) environment; when the 0.5 mT line is outside the Faraday cage
The entire adjacent space or area is considered a magnetic resonance (MR) environment.
[ASTMF2503-05, 3.1.7, modified by. the second sentence into the "note" content]
3.5
Magnetic resonance imaging (MRI) magneticresonanceimaging (MRI)
The imaging technique of obtaining the tissue image by using the static time-varying magnetic field to resonate the nucleus.
[ASTM F2119-07, 2.1.4]
3.6
Passive surgical implants non-activesurgicalimplant
Implant
In addition to the energy generated directly by the human body or gravity, do not rely on energy or other energy to run the surgical implants.
3.7
Safety
Eliminating the unacceptable risk of the state.
[ISO /IEC Guide 51..1999, 3.1]
3.8
Surgical implants
Any device that is implanted or replaced by an epithelial surface or ocular surface by surgical means of ingestion and postoperative retention; or by surgery
Invasion means part of the body into the body but at least 30 days of medical equipment.
4 expected performance
The expected performance of the implant should be described and documented in the following areas, in particular with respect to safety.
a) intended purpose;
b) functional characteristics;
c) the expected conditions of use;
d) life expectancy;
Note. In describing the expected performance of the implant, it should be important to refer to.
--- published standards;
- published clinical and scientific literature;
--- Verified test results.
5 design attributes
In order to achieve the desired performance, design attributes should at least consider the following.
a) Materials and their biocompatibility (see Chapter 6);
b) the physical, mechanical and chemical properties of the material, including persistence and aging (see Chapter 6, Chapter 7);
c) the wear characteristics of the material, and the effects of wear and wear products on the implant and the human body (see Chapter 6, Chapter 7);
d) the degradation characteristics of the material, as well as the effects of degradation, degradation products and leachable materials on the implant and the human body (see Chapter 6, Chapter 7);
e) the extent and effect of material leakage (see Chapter 6, Chapter 7);
f) the safety of animal tissues and their derivatives used in implants or used in their production, for viral and other infectious
Pathogens (including unclassified diseases, prions and similar entities);
g) the impact of the manufacturing process (including sterilization) on the properties and properties of the material (see Chapter 6, Chapter 7, Chapter 8, Chapter 9);
h) the interaction between the constituent materials of the implant and the material of the implant and other materials and substances, the interaction between the implant and its
(See Chapter 6, Chapter 7);
i) interconnection and its impact on expected performance (see Chapter 7);
Note. The shape, size and tolerances of the connections should be taken into account, as well as potential degradation, wear, corrosion and electrolytic effects.
j) the interface of the implant and human tissue (especially the interface associated with fixation and connection) and the surface state (see Chapter 7);
k) shape and size and its possible effects on tissue and body fluids (see Chapter 7);
l) biocompatibility of implants in implantable condition (see Chapter 6, Chapter 7);
m) physical and chemical effects of the human body and the external environment on the implant (see Chapter 7);
n) Effects of radiation, electromagnetic fields and magnetic field environments on implants and their functions and their effects on the human body (see Chapter 6, paragraph
Chapter 7);
Note. Magnetic resonance imaging (MRI) magnetic field on the safety of patients should pay special attention, can refer to ASTMF2052, ASTMF2119,
ASTM F2182 and ASTMF2213 evaluate the safety of implants in magnetic resonance environments.
o) the ability to implant, remove and replace implants (see Chapter 7);
p) the ability to display the position and orientation of the implant by means of radiation or other imaging means;
q) the degree of contamination of microorganisms and particulates (see Chapter 8, Chapter 9, Chapter 10);
r) the applicability and effectiveness of the package (see Chapter 10);
s) if applicable, it is advisable to consider the anatomy and body characteristics of the population for the implant;
t) the condition and pathology of the host tissue;
u) to reduce the use of the wrong surgical techniques and the maintenance and treatment of the implant, provided that the damage does not damage the use of the implant and
performance;
v) Where applicable, the type and nature of the radioactive material used or contained in order to obtain the intended performance, and the reduction or elimination of the patient,
Doctors and other persons exposed to this unwanted radiation risk.
All design attributes of the implant should be recorded. If any of the above design attributes are not relevant, the cause should be recorded and demonstrated.
6 material
The implant material should be selected in accordance with the performance required to achieve the intended purpose, taking into account the manufacturing, handling, sterilization and storage
, And any treatment (chemical, electrochemical, thermal, mechanical, etc.) applied to the surface or part of the surface of the implant for changing its properties.
Consideration should also be given to the possible reaction and radiation of the implant material with human tissue and body fluids as well as other materials, other implants, substances, gases,
Magnetic field and electromagnetic field on the possible impact of the material.
If the drug is an integral part of the implant, the drug should be evaluated on a pharmacological basis. The performance of the drug used in combination with the implant should not be affected
Implants, and vice versa.
Note 1. For the safety, quality and effectiveness of drugs evaluated as part of the implant, please refer to the relevant national regulations.
Materials (including biomaterials) for implants and coatings should be compatible with the biological tissue, cells and body fluids that are to be contacted after implantation
Reach an acceptable level. Possible wear and compatibility of the degradation products should also be acceptable. Bio acceptability in specific applications should be achieved
One of the following methods to determine.
a) an evaluation record in accordance with ISO 10993-1;
b) Choose from materials that have been shown to be suitable for similar clinical applications.
Note 2. Some secondary standards list materials that are considered acceptable in certain applications.
In the case of non-viable or non-viable animal source materials used in the implant or in its manufacturing process,
ISO 22442-1, ISO 22442-2, ISO 22442-3 for the safety of materials, viruses and other infectious pathogens.
Note 3. See ISO 22442-1 Terms and definitions. Animals, organizations.
7 design evaluation
7.1 General
The implants should be evaluated to demonstrate their intended performance (see Chapter 4). Should determine the extent to which the expected performance has been achieved and form the text
Pieces. Safety and expected performance should be achieved through preclinical and clinical evaluation as well as post-marketing follow-up (including ISO 14971 requirements for implants
The appropriate risk management at all stages of the life cycle).
7.2 Preclinical evaluation
The implants should be preclinical based on the following.
a) information on the safety, performance, design characteristics and intended use of the implant;
b) from the analysis of the projections and results data provided by the State and other registries;
c) Analyze the data obtained from the test, including bench tests, if applicable, including from the evaluation of implant safety and expectations
Can get the data.
The pre-clinical evaluation should take into account the similar data of similar implants or similar characteristics of the implant.
Preclinical testing of implants should simulate the intended use of the environment. The relevant limits for the test methods and specific types of implants should be determined by the manufacturer
It is demonstrated that the in vitro manipulation test verifies the intended effect between the implant and the instrument and, if applicable, verifies that the interconnected implant
The expected effect.
In the case of implantation, if applicable, the evaluation of the removal of the implant can not be made directly by comparison with the existing instrument and, if possible,
Evaluation.
If static and/or dynamic load testing is associated with implant evaluation, or using available test criteria, or by considering implantation
The properties of the product are tailored to the test model. Due to the wide variety of implants and their characteristics, there may be no test criteria or may be
Line modification.
Where appropriate, biophysical or modeling studies can be used to demonstrate that the intended performance of the implant is achieved.
The test shall take into account the expected load and/or environmental conditions and, if applicable, the test sample shall, to the extent possible, represent the implant to be implanted.
For a particular implant, its test methods and limits are described in the relevant criteria (e.g., listed in the references).
7.3 Clinical evaluation
Implants should be evaluated on the basis of the following.
a) rigorous review of the safety, performance, design attributes and intended use of implants or similar implants related scientific literature and clinical literature
Offer;
b) all clinical trial results;
c) the combination of clinical data provided by a) and b) above.
Should be in accordance with the requirements of ISO 14155 clinical trials.
Note 1. Clinical trial requirements for specific product types may be included in other relevant international standards.
Note 2. ISO 14155 requires that the clinical trial protocol (CIP) should include follow-up periods for specific items in clinical trials and the reasons for the development of the follow-up period. Follow-up period
Should be sufficient to reflect the true performance of the instrument and to identify the risks associated with evaluating the side effects of the instrument during follow-up.
7.4 Tracking after listing
Should have appropriate systematic procedures to review the post-marketing situation of the implant.
When the manufacturer's risk analysis indicates that the implant has a significant risk of failure or incompatibility with the patient during the life expectancy,
Measures should be taken to ensure that the performance and safety of the implant are maintained.
Note. Suitable methods for monitoring implant performance and safety include survival analysis (end of revision), clinical follow-up, or based on scientific efficacy
Other methods (see reference [3]).
8 manufacturing
The manufacture of implants should be in accordance with the relevant requirements to ensure that the specified design attributes can be achieved.
Note. Manufacturing requirements for specific product types are included in other standards.
9 sterilization
9.1 General
The manufacturer shall demonstrate that the sterilization or repeated sterilization (if applicable) method used does not affect the safety or performance of the implant.
9.2 Products supplied aseptically
The sterilization process should be confirmed and routine controlled.
For a final sterile implant that is labeled & quot; sterile & quot ;, the theoretical probability that the living microorganism appears on or on the surface of the implant should be equal to or
Less than 1 × 10-6.
Note. Requirements for other sterile assurance levels for specific implants can be found in the relevant secondary and tertiary standards.
The manufacturer may use other levels of sterility assurance, but this level should provide a reasonable risk assessment document to prove it. If the implant is picked
Sterilization with ethylene oxide should be in accordance with ISO 11135-1.
If the implant is irradiated with radiation, it shall comply with the requirements of ISO 11137-1 and ISO 11137-2.
If the implant is steam sterilized, it shall comply with ISO 17665-1.
If the implant contains animal source material, and the application of chemical liquid reagent sterilization, should meet the requirements of ISO 14160.
If the implant is sterilized by any other final sterilization method, it shall comply with the requirements of ISO 14937.
If the implant is sterile and should meet the requirements of ISO 13408-1.
9.3 Sterilized by user
9.3.1 Products supplied in a non-sterile state
For implants that are supplied in a non-sterile state, the manufacturer shall specify at least one suitable sterilization method and its appropriate cycle parameters to
So that the safety and performance of the implant will not be adversely affected. If multiple sterilization is not allowed, it should be stated in the information provided by the manufacturer.
(See Chapter 11)
9.3.2 Repeated sterilization
The information provided by the manufacturer should indicate whether the implant can be re-sterilized, and if so, the sterilization method and its cycle parameters should be consistent
ISO 17664. The manufacturer should specify the maximum number of cycles for repeated sterilization, so that the safety and performance of the implant will not be adversely affected.
9.4 Sterilization residue
The test of the sterilized residue shall be carried out in accordance with the principles specified in ISO 10993-1. The level of ethylene oxide residue should not exceed
ISO 10993-7 limits.
10 packs
10.1 to prevent damage to storage and transportation
For each implant, the packaging design shall be such that, at the manufacturer's storage, transport and handling conditions (if applicable,
Degree, humidity, and environmental pressure) to protect the implant from damage and deterioration, and does not adversely affect the implant.
Note 1. If applicable, the test methods given in IEC 60068-2-27, IEC 60068-2-32 or IEC 60068-2-47 may be used.
Note 2. Before using any packaging method, evaluate whether it is suitable for the intended purpose. The evaluation can be carried out under hazardous test conditions to simulate the package
Equipment may encounter bad situation.
10.2 Retention of aseptic status during transfer
Immediate packaging labeled "sterile" should be so packaged that it remains sterile under prescribed storage, transport and handling conditions
Flat, unless the packaging that remains sterile is damaged or opened. Packaging should be in accordance with ISO 11607-1.
11 Information provided by the manufacturer
11.1 General
The information provided by the manufacturer for direct visual recognition, taking the illuminance of 215lx, takes into account the shape and dimensions of individual implants
Inch, with normal vision (if necessary, to correct vision) in the appropriate distance observation, should be clear and easy to read.
Note 1. Information provided in the appropriate place should be easy to understand for prospective users and/or others.
If the instrument packaging container does not have enough space, if applicable, the relevant information can be inserted in the insert, attached documents, or in the adjacent packaging layer
Given.
The identification of certain markers on small implants or special implants may require the use of methods other than visualization, such as electronic methods.
When applicable, symbols, abbreviations and identification colors can be used in the markings and accompanying documents of the implant. The published international standards should be used
(Such as ISO 7000) in the symbols, abbreviations and identify the color. In the absence of relevant standards, the manufacturer should use the documentation contained in the accompanying documentation
Symbols, abbreviations, or identification colors.
The information provided by the manufacturer can not be confused with possible other important information.
Any unit of measurement shall be in the International System of Units (SI) specified in ISO 80000. Equivalent units can be specified in parentheses.
Note 2. ISO 80000-1 provides further guidance on the application of the International System of Units for reference.
Wherever feasible and appropriate, the information required for safe use of the implant should be placed on the packaging itself and/or on the packaging of each unit,
Sales on the packaging. If the individual packaging for each unit is not feasible, the information should be placed in the instructions provided in the package of the implant.
When applicable, the function of the user's adjustable control should be clearly stated.
Any removable part that is used separately from the manufacturer's original implant shall be identified by its lot number or other suitable means.
All (date) year and month should be in accordance with ISO 8601, to 4 digits year -2 months month -2 digits date (YY YY -MM-
DD) or 4-digit year-2-digit month (YY YY -MM) or 4-digit year (YY YY ).
11.2 tags
The label should contain the following information.
a) If the package contains any radioactive material, it shall have a m...