11.080.30 消毒封装 标准查询与下载
共找到 211 条与 消毒封装 相关的标准，共 15 页
本文件描述了无菌医疗器械初包装微粒污染试验方法：液体洗脱法。 本文件适用于表面不规整的泡罩盒类和容器类无菌医疗器械初包装。
Cleanliness of Primary Packaging of Sterile Medical Devices Part 2: Particle Contamination Test Method Liquid Elution Method
- ICS
- 11.080.30
- CCS
- C358
- 发布
- 2020-12-31
- 实施
- 2020-12-31
本文件为应用GB/T 19633.1和GB/T 19633.2中的相关要求提供了指南，并未添加或以其他方式修改GB/T 19633.1和GB/T 19633.2的要求。本文件提供评估、选择和使用包装材料、预成型无菌屏障系统、无菌屏障系统和包装系统的指导方针。还提供成型、密封和装配过程的确认要求指导。针对医疗机构和医疗器械行业分别制定应用指南，并附19个资料性附录做详细指导：附录A 包装材料和无菌屏障系统的选择、评估和测试；附录B 灭菌注意事项；附录C 包裹方法实例；附录D 确认计划文件；附录E 安装鉴定文件；附录F 运行鉴定文件；附录G 性能鉴定文件；附录H 应对最坏情况要求；附录I 建立最终包装系统确认方案；附录J 设计输入—医疗器械特性；附录K 风险分析工具；附录L 抽样计划注意事项；附录M 稳定性试验；附录N 互联网应用；附录O 过程参数建立指南；附录P 合同包装商的使用；附录Q 过程参数建立指南；附录R 调查故障；附录 S 包装生产过程和包装系统设计可行性评估。
Packaging for terminally sterilized medical devices—Guidance on the application of GB/T 19633.1 and GB/T 19633.2
- ICS
- 11.080.30
- CCS
- C358
- 发布
- 2020-12-31
- 实施
- 2020-12-31
本文件对无菌屏障系统的材料和制造、物理性能、性能要求、尺寸、外观、印刷、包装标识等技术要求，以产品规格书的形式，为供需双方达成一致提供了指南。本文件涉及的要求适用于提供无菌屏障系统的供应商和使用无菌屏障系统的器械制造商。本指南可用于双方制定质量协议或技术要求的参考依据。本文件适用于人字形三边封袋，顶头袋和角剥离三边封袋。其他制袋形式经供需双方协商一致，也可以参照执行。
Standard Guide for Writing a Specification for Sterilizable Peel Pouches
- ICS
- 11.080.30
- CCS
- C358
- 发布
- 2020-12-31
- 实施
- 2020-12-31
This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods. In the last few years, following the more and more urge
Sterile packaged ready for filling glass cartridges (ISO 21881:2019)
- ICS
- 11.080.30
- CCS
- 发布
- 2020-12-01
- 实施
This document specifies the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods. In the last few years, following the more and more urgent re
Sterile packaged ready for filling glass vials (ISO 21882:2019)
- ICS
- 11.080.30
- CCS
- 发布
- 2020-12-01
- 实施
DIN 58953-7 applies to the packaging, marking and loading of sterilisation chambers of/with sterilised goods, which are packed in paper bags according to DIN EN 868-4, in sealable transparent bags and tubes made of porous materials and plastic composite film according to DIN EN 8
Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven wrapping material, paper bags and sealable pouches and reels
- ICS
- 11.080.30
- CCS
- C31
- 发布
- 2020-11-01
- 实施
1.1 This test method is to be used to verify a specific material design property. Some flexible barrier materials are designed to have a resistance to the passage of air through the membrane structure. These materials are characterized as nonporous. This test method provides a means to verify this property by challenging a material with a given volume of air under pressure over a specific time period. 1.2 This test method is not intended to measure the diffusion properties of a material nor to identify or quantify the presence of pinhole damage to the design that may result in leaks. 1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
- ICS
- 11.080.30
- CCS
- 发布
- 2020-05-01
- 实施
This 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. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
- ICS
- 11.080.30
- CCS
- 发布
- 2020-01-15
- 实施
- 2020-04-30
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
- ICS
- 11.080.30
- CCS
- 发布
- 2020-01-15
- 实施
- 2020-04-30
What is ISO 21881 – Sterile packaged ready for g lass cartridges about? ISO 21881 discusses Sterile packaged ready for filling glass cartridges. ISO 21881 is an international standard that provides for the filling of empty glass cartridges. ISO 21881 specifies the characteristics of sterile packaged ready for glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems, and analytical test methods. Under ISO 21881 the availability of two packaging configurations makes ready for the filling glass cartridges suitable for use both in clinical trials and in mass production. The duality of packaging configurations calls for standardization of the production processes, materials quality and analytical methods when launching these products on the market, to avoid conceiving too highly customized processes. Who is ISO 21881 – Sterile packaged ready for g lass cartridges for? ISO 21881 on sterile packaged ready for glass cartridges is relevant to: Glass cartridges manufacturer Test centers for glass cartridges for medical purposes Medical laboratories Regulatory authorities Why should you use ISO 21881 – Sterile packaged ready for g lass cartridges ? In the last few years, more and more urgent requests for ready for filling containers is increasing due to which the packaging manufacturers managed to offer to the pharmaceutical industry containers that are already washed and sterilized. This category of products was b...
Sterile packaged ready for filling glass cartridges
- ICS
- 11.080.30
- CCS
- 发布
- 2019-10-31
- 实施
- 2019-10-31
What is ISO 21882 - Sterile packaged ready for g lass vials about? ISO 21882 discusses filling glass vials. ISO 21882 is an international standard that provides for s terile packaged ready for filling glass vials. ISO 21882 outlines the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems, and analytical test methods. Under ISO 21882 the availability of two packaging configurations makes ready for filling glass cartridges suitable for use both in clinical trials and in mass production. The duality of packaging configurations calls for standardization of the production processes, materials quality, and analytical methods when launching these products on the market, to avoid conceiving too highly customized processes. Who is ISO 21882 - Sterile packaged ready for glass vials for? I...
Sterile packaged ready for filling glass vials
- ICS
- 11.080.30
- CCS
- 发布
- 2019-10-31
- 实施
- 2019-10-31
This document specifies the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.
Sterile packaged ready for filling glass vials
- ICS
- 11.080.30
- CCS
- 发布
- 2019-10-18
- 实施
This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.
Sterile packaged ready for filling glass cartridges
- ICS
- 11.080.30
- CCS
- 发布
- 2019-10-18
- 实施
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2019-03-01
- 实施
This 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. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
- ICS
- 11.080.30
- CCS
- 发布
- 2019-01-31
- 实施
- 0000-00-00
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
- ICS
- 11.080.30
- CCS
- 发布
- 2019-01-31
- 实施
- 0000-00-00
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- 发布
- 2018-11-05
- 实施
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- 发布
- 2018-11-05
- 实施
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- 发布
- 2018-11-05
- 实施
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- 发布
- 2018-11-05
- 实施
