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GB/T 19633.1-2015 (GB/T19633.1-2015)

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GB/T 19633.1-2015: PDF in English (GBT 19633.1-2015)
GB/T 19633.1-2015
Packaging for terminally sterilized medical devices - Part 1.Requirements for materials, sterile barrier systems and packaging systems
ICS 11.080.30
National Standards of People's Republic of China
Partly replace GB/T 19633-2005
Terminally sterilized medical device packaging
Part 1.Materials, sterile barrier systems and
Packaging system requirements
(ISO 11607-1.2006, IDT)
Released on.2015-12-10 Implemented on.2016-09-01
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Issued by China National Standardization Administration
Table of contents
Preface Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General requirements 4
5 Materials and pre-formed sterile barrier systems 5
6 Design and development requirements of packaging system 8
7 Information to be provided 9
Appendix A (informative appendix) Medical Packaging Guidelines 11
Appendix B (informative appendix) Standard test methods and procedures that can be used to verify compliance with the requirements of this part of GB/T 19633 13
Appendix C (Normative appendix) Test methods for gas impermeable materials to prevent gas passage 17
Reference 18
GB/T 19633 "Terminal Sterilization Medical Device Packaging" is divided into two parts.
---Part 1.Requirements for materials, sterile barrier systems and packaging systems;
---Part 2.Requirements for confirmation of forming, sealing and assembly processes.
This part is Part 1 of GB/T 19633.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 19663-2005 "Packaging of Terminally Sterilized Medical Devices". Compared with GB/T 19663-2005, it is mainly
The main technical content changes are as follows.
---Detailed considerations for the design and development of the packaging system;
---Added the packaging system performance test;
---Added stability test;
---Added information to be provided;
---Appendix A and Appendix B have been added.
The translation method used in this part is equivalent to the international standard ISO 11607-1.2006 "Terminal Sterilization Medical Device Packaging Part 1.Materials
Requirements for materials, sterile barrier systems and packaging systems.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC210).
This section was drafted by. Jinan Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
The main drafters of this section. Wu Ping, Zhang Limei, Liu Chenghu.
The previous versions of the standards replaced by this part are as follows.
---GB/T 19633-2005.
The process of designing and developing terminally sterilized medical device packaging is a complex and important task. Co-construction of device components and packaging system
The effectiveness and safety of the product are established, so that it can be used effectively in the hands of users.
This part of GB/T 19633 specifies the expected use in consideration of material scope, medical devices, packaging system design and sterilization methods.
Basic requirements for materials and pre-formed systems for terminally sterilized medical device packaging systems. GB/T 19633.2 describes forming, sealing and assembly
Process validation requirements. This part specifies the general requirements for all packaging materials, while YY/T 0698.1~YY/T 0698.10 stipulates
Specific requirements for commonly used materials have been introduced. The two parts of GB/T 19633 are also designed to meet the Basic Requirements of the European Medical Device Directive.
For specific materials and pre-formed sterile barrier systems, please refer to the YY/T 0698 series of standards. Meet YY/T 0698.1~
YY/T 0698.10 can be used to verify compliance with one or more of the requirements of this section.
The goal of the terminally sterilized medical device packaging system is to be able to sterilize, provide physical protection, and maintain the sterile state before use.
Bacteria take. The specific characteristics of medical devices, expected sterilization methods, expected use, expiry date, transportation and storage all contribute to the design of the packaging system
And the choice of materials.
During the formulation of ISO 11607-1, one of the main obstacles encountered was the coordination of terminology. The term "packaging" "final packaging" "initial packaging"
"Installation" has different meanings in the world. Therefore, which of these terms is considered to be a barrier to ISO 11607-1?
hinder. As a result of the coordination, the term "sterile barrier system" was introduced to describe the unique functions required to perform medical device packaging
The smallest packaging. Its unique functions are. it can be sterilized, provide an acceptable microbial barrier, and can be taken aseptically. "Protective Packaging"
It is used to protect the aseptic barrier system, and the aseptic barrier system and protective packaging constitute the packaging system. "Pre-formed sterile barrier system" can be included
Including any sterile barrier systems that have been partially assembled, such as combination bags, head bags, hospital packaging materials, etc. Appendix A gives sterile
Overview of the barrier system.
The sterile barrier system is the basic guarantee for the safety of terminally sterilized medical devices. The regulatory agency regards the sterile barrier system as a medical
An accessory or a component of a medical device recognizes the important characteristics of a sterile barrier system. Sold to many places in the world
A pre-formed sterile barrier system used for sterilization in a medical institution is considered a medical device.
Terminally sterilized medical device packaging
Part 1.Materials, sterile barrier systems and
Packaging system requirements
1 Scope
This part of GB/T 19633 specifies the materials, pre-formed sterile barrier systems, sterile barrier systems and expected to remain final before use.
Requirements and test methods for sterile packaging systems for sterilized medical devices.
This section applies to industries, medical institutions, and any situation where medical devices are sterilized after being installed in a sterile barrier system.
This section does not include all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. Affection for drug and device combination
However, other requirements may also be required.
This section does not describe the quality assurance system for all manufacturing stages.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
ISO 5636-5.2003 Determination of air permeability of paper and paperboard (medium range) Part 5.Gurley method (Paperand
board-Determinationofairpermeanceandairresistance(mediumrange)-Part 5.Gurleymethod)
3 Terms and definitions
The following terms and definitions apply to this document.
Aseptic presentation
Use conditions and procedures that are free from microbial contamination to remove and deliver a sterile product.
The number of surviving microorganisms on the product or sterile barrier system, or in the product or sterile barrier system.
[ISO /T 11139.2006]
Close the sterile barrier system in a way that does not form a seal.
Note. For example, with a reusable container gasket, or repeated folding to form a tortuous path, a sterile barrier system can be closed.
Ensuring the closure characteristics to prevent the entry of microorganisms under specified conditions.
Note. See also 3.8.
At least a date expressed in year and month before which the product can be used.
It is fixed on the medical device or its packaging system by writing, printing, electronic or graphic symbols, or on the documents accompanying the medical device.
Note. Labels are documents related to the identification, technical description and use of medical devices, but do not include transportation documents.
The manufacturer’s intended use is to be applied to humans for one or more of the following specific purposes, whether used alone or in combination
Instruments, equipment, appliances, machines, appliances, implants, in vitro reagents or calibrators, software, materials or other related items. These purposes are.
---Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
---Injury diagnosis, monitoring, treatment, mitigation or compensation;
---Research, substitution, adjustment or support of anatomical or physiological processes;
---Support or sustain life;
---Pregnancy control;
---Disinfection of medical equipment;
---Provide medical information through in vitro examination of samples taken from the human body.
Its main expected effect on the surface or body of the human 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. This definition comes from YY/T 0287-2003/ISO 13485.2003, which is given by the Global Coordination Task Force (GHTF2002).
The ability of a sterile barrier system to prevent the entry of microorganisms under specified conditions.
Any material used to manufacture or seal packaging systems.
Combination of sterile barrier system and protective packaging.
Partially assembled aseptic barrier system (3.22) for loading and final closing or sealing has been completed.
Examples. paper bags, combination bags, and open reusable containers.
The result of the process.
[GB/T 19000-2008]
Note. In the sterilization standard, the product is a tangible entity, which can be raw materials, intermediates, components and medical products.
[ISO /T S11139.2006]
Protective packaging
A material structure to prevent the sterile barrier system and its contents from being damaged during the period from its assembly to the final use.
[ISO /T S11139.2006]
Through the production process of reprocessing the waste, it can be used for the original purpose or other purposes.
When measuring under the same measurement conditions, the degree of consistency between consecutive measurement results of the same specific measured.
Note 1.These conditions are called repeatability conditions.
Note 2.Repeatability conditions can include.
---The same measurement procedure;
---The same observer;
---Use the same measuring instrument under the same conditions;
--- same place;
---Repetition in the short term.
Note 3.Repeatability can be quantitatively characterized by the discrete characteristics of the results.
Note 4.From "International Basic Vocabulary and General Terminology in Metrology",.1993, definition 3.6.
The degree of consistency between the measurement results of the same specific measurement when the measurement (metering) is changed under the measurement conditions.
Note 1.To be able to effectively express reproducibility, the conditions for change need to be regulated.
Note 2.The changed conditions can include.
---Measurement principle;
---Measurement methods;
---measuring instrument;
---Conditions of Use;
Note 3.Reproducibility can be quantitatively characterized by the discrete characteristics of the results.
Note 4.From "International Basic Vocabulary and General Terminology in Metrology",.1993, definition 3.7.
Designed as a rigid sterile barrier system that can be used repeatedly.
The result of surfaces joining together.
Note. For example, use adhesives or hot melt to connect the surfaces together.
Sealed under specified conditions to ensure the characteristics of preventing the entry of microorganisms.
Note. See also 3.8.
Seal strength sealstrength
The mechanical strength of the seal.
No viable microorganisms.
[ISO /T S11139.2006]
Sterile barrier system
The smallest packaging that prevents the entry of microorganisms and enables the product to be taken aseptically at the place of use.
Port protection sleeves and/or packaging systems designed to ensure that the parts of the medical device intended to come into contact with liquid are sterile.
Note. The inside of the pipeline for intravenous infusion is an example of aseptic fluid packaging.
Sterilization compatibility
The packaging material and/or system can withstand the sterilization process and make the packaging system reach the required conditions for sterilization.
Sterilizing agent
It is a sterile physical entity, chemical entity or combination entity that has sufficient inactivation properties under specified conditions.
[ISO /T S11139.2006]
The process in which a product is sterilized in its sterile barrier system.
Time to meet all performance requirements.
(General) It is determined by testing and providing objective evidence that the special requirements of a specific intended use can be continuously met.
Note. This definition applies to the verification of test methods and design.
(Process) By obtaining, recording and interpreting the required results to prove that a certain process can continue to produce products that meet predetermined specifications
Documented procedures.
Note. From ISO /T S11139.2006.
4 General requirements
4.1 General
One or more parts in YY/T 0698.1~YY/T 0698.10 can be used to verify compliance with one or more requirements of this part.
4.2 Quality System
4.2.1 The activities described in this section should be run under a formal quality system.
Note. GB/T 19001 and YY/T 0287 give the applicable quality system requirements. Countries or regions may stipulate other requirements.
4.2.2 It is not necessary to obtain third-party quality system certification to meet the requirements of this section.
4.2.3 Medical institutions can adopt the quality system required by their country or region.
4.3 Sampling
The sampling plan used to select and test the packaging system should be suitable for the packaging system being evaluated. The sampling plan should be based on statistical principles
Note. GB/T 2828.1 or GB/T 450 gives a suitable sampling plan. Some countries or regions may also provide other sampling plans.
4.4 Test method
4.4.1 All test methods used to show compliance with this section should be confirmed and documented.
Note. Appendix B contains a list of suitable test methods.
4.4.2 The test method validation shall confirm the suitability of the method used. The following elements should be included.
---Determine the selection principle of the corresponding test of the packaging system;
---Determine acceptable criteria;
Note. Pass/Fail is a form of acceptance criteria.
---Determine the repeatability of the test method;
---Determine the reproducibility of the test method;
---Determine the sensitivity of the integrity test method.
4.4.3 Unless otherwise specified in the test method, the test sample should be carried out under the conditions of (23±1)℃ and (50±2)% relative humidity
Adjust for at least 24h.
4.5 Documenting
4.5.1 Demonstration of compliance with the requirements of this part shall be documented.
4.5.2 All documents should be kept for a specified period. The factors that should be considered in the shelf life are regulatory requirements, medical devices or sterilization barrier systems.
The validity period and traceability of the system.
4.5.3 Documents that meet the requirements can include (but are not limited to) performance data, technical specifications and test results from confirmed test methods.
4.5.4 The electronic records, electronic signatures and hand-signed electronic records used for validation, process control or other quality decision-making processes shall be authentic and reliable.
5 Materials and pre-formed sterile barrier system
5.1 General requirements
5.1.1 The requirements for the materials involved shall apply to pre-formed sterile barrier systems and sterile barrier systems.
5.1.2 The requirements listed in this article (5.1) are not all requirements. For some material properties not listed in this article, Chapter 6 may be required
The performance criteria given are evaluated.
5.1.3 The production and handling conditions of materials and/or pre-formed sterile barrier systems shall be established, controlled and recorded (if applicable) to ensure.
a) These conditions are compatible with the use of materials and/or sterile barrier systems;
b) The properties of the material and/or sterile barrier system are maintained.
5.1.4 At least the following aspects should be considered.
a) Temperature range;
b) Pressure range;
c) Humidity range;
d) The maximum rate of change of the above three items (if necessary);
e) Exposure to sunlight or ultraviolet light;
f) Cleanliness;
g) Bioburden;
h) Electrostatic conductivity.
5.1.5 The source, history and traceability of all materials, especially recycled materials, should be understood and controlled to ensure that the final product continues to comply with
Meet the requirements of this section.
Note. Using today's industrial production technology, in addition to the production of recycled materials other than recycled materials, it is impossible to control them safely for medical device packaging.
5.1.6 The following characteristics shall be evaluated.
a) Microbial barrier;
b) Biocompatibility and toxicological properties;
Note. This generally applies to materials in contact with the device. GB/T 16886.1 gives guidelines for biocompatibility. The effect of sterilization on biocompatibility should be evaluated.
c) Physical and chemical characteristics;
d) Adaptability to the forming and sealing process;
e) Adaptability to the expected sterilization process (see 5.3);
f) The storage life before and after sterilization.
5.1.7 Materials, such as wrapping materials, such as paper, plastic film or non-woven fabrics or reusable fabrics should meet the following general properties
a) The material should be free of leachables and tasteless under the specified conditions, and should not adversely affect the performance and safety of medical devices in contact with it
Note. Since the odor can be a consensus, there is no need to use standardized test methods to determine the odor.
b) There should be no perforations, breakages, tears, wrinkles or partial thickness unevenness on the material that affect the function of the material;
c) The basic weight (mass per unit area) of the material should be consistent with the specified value;
d) The materials should have acceptable levels of cleanliness, particulate contamination and flocculation;
e) The material should meet the specified or minimum physical performance requirements, such as tensile strength, thickness difference, tear resistance, air permeability and burst resistance;
f) The material should meet the established minimum chemical properties, such as pH value, chloride and sulfate content, to meet the requirements of medical devices, packaging systems
System or sterilization process requirements;
g) Under the conditions of use, the material should not contain or release enough to cause health hazards, whether before, during or after sterilization.
Of toxic substances.
5.1.8 In addition to the requirements given in 5.1.1 ~ 5.1.7, the material of the glue layer shall also meet the following requirements.
a) The coating should be continuous, and there should be no gaps or discontinuities so as not to cause discontinuities in the seal;
b) The quality of the coating should be consistent with the nominal value;
c) When the material forms a seal with another specific material under specified conditions, it shall be confirmed to have the specified minimum sealing strength.
5.1.9 In addition to conforming to 5.1.1 to 5.1.7 and 5.1.8 (if applicable), the sterile barrier system and pre-formed sterile barrier system shall also comply with the following
a) Before, during, and after the prescribed sterilization process, the materials and their composition, such as coating, ink or chemical indicators, should not be
The medical device reacts, contaminates and/or migrates to it, so as not to have side effects on the medical device;
b) If it is sealed, the width and strength of the seal (tensile strength and/or burst resistance) should meet the specified requirements;
c) The peeling structure should have continuous and uniform peeling characteristics, and does not affect the delamination or tearing of the materials for aseptic opening and retrieval;
Note 1.Paper bags and heat-sealed combination bags and roll materials have structural and design requirements, as well as performance requirements.
Note 2.If the seal is expected to be used aseptically after opening, it may be necessary to specify the maximum seal strength.
d) The seal and/or closure should form a microbial barrier.
5.1.10 For reusable containers, in addition to meeting the requirements of 5.1.1 to 5.1.7, the following requirements should also be met.
a) Each container should have an "open sign" system that can provide clear instructions when the integrity of the closure is compromised;
b) During the removal, transportation and storage from the sterilizer, the entrance and exit of the sterilization medium should provide a microbial barrier (see 5.2);
c) After the formation of the microbial barrier system, its closure should provide a barrier to microorganisms;
d) The structure of the container should facilitate inspection of all basic components;
e) The acceptance criteria for each repetitive pre-use inspection should be established;
Note 1.The most common inspection procedure is visual inspection, there may be other acceptable methods.
f) The parts of the container of the same modulus should be completely interchangeable, and the parts of the container of different modulus cannot be interchanged;
Note 2.Appropriate codes and/or labels can be used to meet this design requirement.
g) Services, cleaning procedures, and component inspection, maintenance and replacement methods should be specified.
Note 3.For other guidelines for reusable containers, see YY/T 0698.8.
5.1.11 For reusable fabrics, in addition to meeting the requirements of 5.1.1 to 5.1.7 and 5.1.8 (if applicable), the following requirements should also be met.
a) The material should meet the performance requirements after repairing and each sterilization;
b) Washing and finishing procedures should be established and documented;
Note. This may include visual inspection, other test methods and acceptance criteria for reuse.
c) The processing procedure should be given on the product label.
5.1.12 For reusable sterile barrier systems, including containers and fabrics, it should be determined whether they will cause degradation when handled according to the instructions provided.
Solution, thereby affecting the service life. When degradation is expected, the maximum allowable number of treatments or the end of service life should be given in the product label
Should be measurable.
5.2 Microbial barrier properties
5.2.1 The impermeability of the material shall be determined in accordance with Appendix C.
Note. The microbial barrier properties of the materials used in the sterile barrier system are very important to ensure the integrity of the packaging and the safety of the product. Evaluation of microbial barrier properties
The methods are divided into two categories. methods suitable for impermeable materials and methods suitable for breathable materials.
5.2.2 After confirming that the material is impermeable, it means that it meets the requirements of the microbial barrier.
5.2.3 Permeable materials should be able to provide a suitable microbial barrier to provide the integrity of the aseptic barrier system and product safety.
Note. There is no universal method to verify the characteristics of the microbial barrier. The evaluation of the microbial barrier properties of breathable materials is usually performed under specified test conditions (through
The aerosol or particles carrying bacterial spores flow through the sample material under the flow rate of the material, the challenge strain and the test time), so as to challenge the sample.
Test. Under the test conditions specified here, the number of bacteria or particles after passing the material is compared with its initial number to determine the microbial growth of the material.
Physical barrier properties. As long as the confirmed physical test method corresponds to the confirmed microbial challenge method, the data obtained can also be used
Determine the microbial barrier properties. In the future, when there are confirmed materials and microbial barrier system microbial challenge methods, they will be considered for inclusion in this section
in. (For details, see SinclairandTalentire2002[41], TalentireandSinclair1996[40], Scholaetal.1995[39] and Scholaet
5.3 Adaptation to the sterilization process
5.3.1 It should be verified that the materials and pre-formed sterile barrier system are suitable for the sterilization process and cycle parameters for its intended use.
5.3.2 To determine the suitability of sterilization, sterilizers designed, produced and operated in accordance with relevant international standards or European standards should be used.
Note. For example, see ISO 17665-1, ISO 11135, ISO 11137 (all parts), ISO 14937, EN285, EN550, EN552, EN554,
EN1422 or EN14180.When ISO 11607.2006 was formulated, these international standards and European standards were in coordination.
5.3.3 The performance of the material should be evaluated to ensure that the performance of the material is still within the specified limits after being subjected to the specified sterilization process.
5.3.4 The prescribed sterilization process may include multiple exposure to the same or different sterilization process.
5.3.5 The determination of the suitability for the intended use should take into account the changes that will occur in the regular supply of materials.
5.3.6 When the product is multi-layered or multi-layered, the performance of the inner and outer layer materials can be differently limited.
5.3.7 The determination of suitability can be carried out simultaneously with the confirmation of the sterilization process to be adopted.
5.4 Adaptability to the labeling system
The labeling system should.
a) Keep it complete and clear before use;
b) During and after the specified sterilization process and cycle parameters, it is compatible with materials, sterile barrier systems and medical devices,
Should not cause adverse effects on the sterilization process;
c) Ink should not migrate to the device or react with packaging materials and/or systems, thereby affecting the effectiveness of packaging materials and/or systems
It should not change its color to make the label difficult to identify.
Note. The labeling system can have many forms. Including printing or writing directly on the material and/or sterile barrier system, or by pasting, heat sealing or other methods
Another layer of material on the label is bonded to the surface of the material and/or system.