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GB/T 19633.1-2015 English PDF (GBT19633.1-2015)

GB/T 19633.1-2015 English PDF (GBT19633.1-2015)

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GB/T 19633.1-2015: Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems

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
C47
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
Preface
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.
introduction
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.
3.1
Aseptic presentation
Use conditions and procedures that are free from microbial contamination to remove and deliver a sterile product. 3.2
Bioburden
The number of surviving microorganisms on the product or sterile barrier system, or in the product or sterile barrier system. [ISO /T 11139.2006]
3.3
Closure
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. 3.4
Closureintegrity
Ensuring the closure characteristics to prevent the entry of microorganisms under specified conditions. Note. See also 3.8.
3.5
Expirydate
At least a date expressed in year and month before which the product can be used. 3.6
Labeling
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. 3.7
Medicaldevice
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). 3.8
Microbialbarrier
The ability of a sterile barrier system to prevent the entry of microorganisms under specified conditions. 3.9
Packagingmaterial
Any material used to manufacture or seal packaging systems.
3.10
Packagingsystem
Combination of sterile barrier system and protective packaging.
3.11
Preformedsterilebarriersystem
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.
3.12
Product
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]
3.13
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]
3.14
Recycledmaterial
Through the production process of reprocessing the waste, it can be used for the original purpose or other purposes. 3.15
Repeatability
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. 3.16
Reproducibility
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;
---Observer;
---measuring instrument;
---Benchmark;
---location;
---Conditions of Use;
---time.
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. 3.17
Reusablecontainer
Designed as a rigid sterile barrier system that can be used repeatedly. 3.18
Seal
The result of surfaces joining together.
Note. For example, use adhesives or hot melt to connect the surfaces together. 3.19
Sealintegrity
Sealed under specified conditions to ensure the characteristics of preventing the entry of microorganisms. Note. See also 3.8.
3.20
Seal strength sealstrength
The mechanical strength of the seal.
3.21
Sterile
No viable microorganisms.
[ISO /T S11139.2006]
3.22
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. 3.23
Sterilefluid-pathpackaging
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. 3.24
Sterilization compatibility
The packaging material and/or system can withstand the sterilization process and make the packaging system reach the required conditions for sterilization. 3.25
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]
3.26
Terminalsterilized
The process in which a product is sterilized in its sterile barrier system. 3.27
Usefullife
Time to meet all performance requirements.
3.28
Validation
(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. 3.29
Validation
(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 Above.
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 Claim.
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 influences;
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 par...

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