GB/T 19633.1-2024 PDF EnglishUS$905.00 · In stock · Download in 9 seconds
GB/T 19633.1-2024: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB/T 19633.1: Historical versions
Similar standardsGB/T 19633.1-2024: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT19633.1-2024 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080.01 CCS C 47 GB/T 19633.1-2024 / ISO 11607-1.2019 Replacing GB/T 19633.1-2015 Packaging for Terminally Sterilized Medical Devices – Part 1.Requirements for Materials, Sterile Barrier Systems and Packaging Systems (ISO 11607-1.2019, IDT) Issued on: MAY 28, 2024 Implemented on: DECEMBER 1, 2025 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 Introduction... 6 1 Scope... 8 2 Normative References... 8 3 Terms and Definitions... 9 4 General Requirements... 16 5 Materials, Preformed Sterile Barrier Systems and Sterile Barrier Systems... 18 6 Design and Development for Packaging Systems... 24 7 Usability Evaluation for Aseptic Presentation... 26 8 Packaging System Performance and Stability... 27 9 Packaging System Validation and Changes... 28 10 Inspection Immediately Prior to Aseptic Presentation... 29 11 Information to be Provided... 29 Annex A (Informative) Guidance on Medical Packaging... 31 Annex B (Informative) Standardized Test Methods, Guides and Procedures That Can be Used to Demonstrate Conformity with the Requirements of This Document... 34 Annex C (Normative) Test Method for Resistance of Impermeable Materials to the Passage of Air... 52 Annex D (Informative) Environmental Aspects... 53 Annex E (Informative) Draft Guidance on Ways to Differentiate a Sterile Barrier System from Protective Packaging... 54 Annex F (Normative) Risk Management... 59 Annex G (Informative) Risk Management for Medical Device Packaging - Rationale for Requirements... 64 Bibliography... 76ForewordThis Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents. This Document is Part 1 of GB/T 19633 Packaging for Terminally Sterilized Medical Devices. GB/T 19633 has published the following parts. --- Part 1.Requirements for Materials, Sterile Barrier Systems and Packaging Systems; --- Part 2.Validation Requirements for Forming, Sealing and Assembly Processes. This Document replaced GB/T 19633.1-2015 Packaging for Terminally Sterilized Medical Devices - Part 1.Requirements for Materials, Sterile Barrier Systems and Packaging Systems. Compared with GB/T 19633.1-2015, the major technical changes of this Document are as follows besides the structural adjustments and editorial modifications. --- Change the description of scope (see Clause 1 of this Edition; Clause 1 of the 2015 Edition); --- Add the terms "control", "supervision", "terminally sterilized", "expiration date", "hazard", "intended use", "intended purpose", "process", "reasonably foreseeable misuse", "risk" and their definitions (see 3.5, 3.10, 3.28, 3.29, 3.32, 3.33, 3.34, 3.35 and 3.36 of this Edition); --- Delete the terms "packaging material" and "recycled material" and their definitions (see 3.9 and 3.14 of the 2015 Edition); --- Add the requirements for risk management (see 4.2, Annex F of this Edition); --- Add the sampling requirements for materials and sterile barrier systems (see 4.3 of this Edition); --- Add the requirements for the microbial barrier properties of materials [see 5.1.7h) of this Edition]; --- Add the requirements for confirming compliance with ISO11607-2 and the sub-clause for reversible seals or closures [see 5.1.9 a), f) of this Edition]; --- Add requirements for aseptic access (see 6.1.2 of this Edition); --- Add performance evaluation requirements for selection and confirmation of materials and preformed aseptic barrier systems (see 6.2.2 of this Edition); --- Add labeling requirements on protective packaging of aseptic liquid products (see 6.2.5 of this Edition); --- Add requirements for usability evaluation of aseptic access (see Clause 7 of this Edition); --- Add general requirements for performance and stability of packaging systems (see 8.1 of this Edition); --- Change the test objects of performance tests (see 8.2.2 of this Edition; 6.3.4 of the 2015 Edition); --- Add requirements for forming documents to determine the worst-case principle (see 8.2.3 of this Edition); --- Change the time when real-time aging starts (see 8.3.4 of this Edition; 6.4.4 of the 2015 Edition); --- Add packaging system validation and changes (see Clause 9 of this Edition); --- Add requirements for inspection immediately prior to aseptic presentation (see Clause 10 of this Edition). This Document equivalently adopted ISO 11607-1.2019 Packaging for Terminally Sterilized Medical Devices – Part 1.Requirements for Materials, Sterile Barrier Systems and Packaging Systems. The following minimal editorial changes were made to this Document. --- Incorporate the amendments of ISO11607-1.2019/Amd.1.2023, and the outer margins of the involved clauses are marked with vertical double lines (‖); --- Add NOTE 2 to 3.8; --- Adjust the format of Table B.1, adding a column "Chinese standard number corresponding to the reference standard", and merged "reference standard" and "name" into one column; --- Added NOTE to Annex E; --- Change the numbers of the NOTEs in F.2 and F.7. Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Document was proposed by National Meical Products Administration. This Document shall be under the jurisdiction of National Technical Committee on Disinfection Technology and Equipment of Standardization Administration of China (SAC/TC 200). Drafting organizations of this Document. Guangdong Medical Devices Quality Surveillance and Test Institute; Shanghai MicroPort Medical (Group) Co., Ltd.; DuPont (China) Research & Development and Management Company Limited; Micro-Tech (Nanjing) Co., Ltd.; Shanghai Jianzhong Medical Packaging Co., Ltd.; and Amcor Group, Bemis Flexible Packaging (Suzhou) Co., Ltd. Chief drafting staffs of this Document. Wan Yiyi, Li Ran, Qin Lei, Ding Yanqin, Wang Youqiong, Qian Jun, Wang Fangying, Yuan Biyu, Li Yong, Li Ning, Song Yiqin, and Wang Qing. The historical editions replaced by this Standard are as follows. --- GB/T 19633-2005 Packaging for Terminally Sterilized Medical Devices was first-time published in 2005; --- It was first-time revised in 2015; the standard number and name was adjusted into GB/T 19633.1-2015 Packaging for Terminally Sterilized Medical Devices - Part 1. Requirements for Materials, Sterile Barrier Systems and Packaging Systems.1 ScopeThis Document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.2 Normative ReferencesThe provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document. ISO 5636-5 Paper and board – Determination of air permeance (medium range) – Part 5. Gurley method 3.1 Aseptic presentation Transfer of sterile contents from its sterile barrier system using conditions and procedures that minimize the risk of microbial contamination. 3.2 Bioburden Population of viable microorganisms on or in product and/or sterile barrier system.4 General Requirements4.1 Quality systems The activities described within this document shall be carried out within a formal quality system. 4.2 Risk management A risk management process conforming with the requirements of Annex F shall be implemented.5 Materials, Preformed Sterile Barrier Systems and SterileBarrier Systems 5.1 General requirements 5.1.1 Materials and/or preformed sterile barrier systems shall be selected to fulfil the goals of a terminally sterilized medical device packaging system. 5.2 Microbial barrier properties 5.2.1 If not a declared porous material, the impermeability shall be determined in accordance with Annex C.6 Design and Development for Packaging Systems6.1 General 6.1.1 The packaging system shall be designed to minimize the risks, as specified in Annex F, to the user and patient during intended use and/or reasonably foreseeable misuse.7 Usability Evaluation for Aseptic Presentation7.1 A documented usability evaluation shall be conducted to demonstrate that the sterile contents can be aseptically removed from the sterile barrier system for presentation.8 Packaging System Performance and Stability8.1 General Sterile barrier system integrity testing shall be performed after packaging system performance testing and stability testing on sterilized samples.9 Packaging System Validation and ChangesDocuments concerning packaging system designs shall be covered by a change control procedure for documenting, verifying and authorizing change. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of GB/T 19633.1-2024 be delivered?Answer: The full copy PDF of English version of GB/T 19633.1-2024 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of GB/T 19633.1-2024_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 19633.1-2024_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB/T 19633.1-2024 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.Question 5: Should I purchase the latest version GB/T 19633.1-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 19633.1-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.How to buy and download a true PDF of English version of GB/T 19633.1-2024?A step-by-step guide to download PDF of GB/T 19633.1-2024_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).Step 2: Search keyword "GB/T 19633.1-2024". Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart. Step 4: Select payment option (Via payment agents Stripe or PayPal). Step 5: Customize Tax Invoice -- Fill up your email etc. Step 6: Click "Checkout". Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively. Step 8: Optional -- Go to download PDF. Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice. See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9 |
