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

Delivery: 3 seconds. Download true-PDF + Invoice.Newer version: (Replacing this standard) GB/T 19633.1-2024
Get QUOTATION in 1-minute: Click GB/T 19633.1-2015
Historical versions: GB/T 19633.1-2015
Preview True-PDF (Reload/Scroll if blank)

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 t...