11.080.30 消毒封装 标准查询与下载
共找到 210 条与 消毒封装 相关的标准，共 14 页
GB/T 19633的本部分规定了最终灭菌医疗器械的包装过程的开发与确认要求。这些过程包括了预成形无菌屏障系统、无菌屏障系统和包装系统的成形、密封和装配。 本部分适用于工业、医疗机构对医疗器械的包装和灭菌。 本部分不包括无菌制造医疗器械的包装要求。对于药物与器械的组合，还可能有其他要求。
Packaging for terminally sterilized medical devices.Part 2:Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2015-12-10
- 实施
- 2016-09-01
1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials. 1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available. 1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. 1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019. 1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide. 1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.” 1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for sterile barrier systems. 1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.9 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. 1.10 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 Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- ICS
- 11.080.30
- CCS
- 发布
- 2024-04-25
- 实施
BS EN 868-3 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
- ICS
- 11.080.30
- CCS
- 发布
- 2024-04-11
- 实施
- 2024-04-11
BS EN 868-4 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
- ICS
- 11.080.30
- CCS
- 发布
- 2024-04-11
- 实施
- 2024-04-11
BS EN 868-6 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
- ICS
- 11.080.30
- CCS
- 发布
- 2024-04-11
- 实施
- 2024-04-11
BS EN 868-7 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
- ICS
- 11.080.30
- CCS
- 发布
- 2024-04-11
- 实施
- 2024-04-11
BS EN 868-2 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
- ICS
- 11.080.30
- CCS
- 发布
- 2024-04-11
- 实施
- 2024-04-11
本文件给出了无菌医疗器械初包装材料落絮微粒污染试验方法：干态落絮试验方法。 本文件适用于由各种纤维构成的无菌医疗器械初包装材料。
Cleanliness of primary package for sterile medical device Part 4：Test method for linting in the dry state of fibrous material
- ICS
- 11.080.30
- CCS
- C358
- 发布
- 2024-01-02
- 实施
- 2024-01-03
本文件规定了无菌医疗器械初包装和/或初包装材料洁净度按T/CAMDI 009系列标准试验的污染限量要求。 本文件适用于无菌医疗器械初包装和/或初包装材料制造商，也适用于无菌医疗器械制造商。
Cleanliness of primary package for sterile medical device Part 10：Limits of contamination
- ICS
- 11.080.30
- CCS
- C358
- 发布
- 2024-01-02
- 实施
- 2024-01-03
Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- 发布
- 2023-11-30
- 实施
- 2023-11-30
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等。
Sterilizable packaging films for medical devices
- ICS
- 11.080.30
- CCS
- C292
- 发布
- 2023-05-11
- 实施
- 2023-06-11
1 Scope This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities. The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and illustrates the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate conformity with them. Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given. This document provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices. This document does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply.
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
- ICS
- 11.080.30
- CCS
- 发布
- 2023-05-01
- 实施
无菌医疗器械的初包装是无菌医疗器械的组成部分，因此其洁净度直接影响无菌医疗器械的洁净度。这就要求初包装要在足够洁净的条件下生产。对于某些特殊器械的初包装，可能要求在与无菌医疗器械同等洁净度的生产环境下生产或进行末道清洗。
Cleanliness of primary package for sterile medical device – Part 3：Test methods for estimating the total number of microorganisms
- ICS
- 11.080.30
- CCS
- C358
- 发布
- 2023-04-20
- 实施
- 2023-04-20
无菌医疗器械的初包装是无菌医疗器械的组成部分，因此其洁净度直接影响到无菌医疗器械的洁净度。这就要求初包装要在有足够洁净的条件下生产。对于某些特殊器械的初包装，可能要求在与无菌医疗器械同等洁净度的生产环境下生产或进行末道清洗 无菌医疗器械的初包装的洁净度可从以下几个方面进行评价： ——微粒污染物； ——微生物负载； ——细菌内毒素。
Cleanliness of primary package for sterile medical device - Part 10：Limits of contamination
- ICS
- 11.080.30
- CCS
- C358
- 发布
- 2023-04-20
- 实施
- 2023-04-20
1 Scope 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 - Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- 发布
- 2022-09-30
- 实施
- 2022-09-30
BS EN ISO 11607-1:2019 AMD1. Packaging for terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- 发布
- 2022-08-04
- 实施
- 2022-08-04
BS ISO 11607-2:2019/AMD1. Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- 发布
- 2022-08-03
- 实施
- 2022-08-03
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
- 2022-06-15
- 实施
- 2022-09-30
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
- 2022-06-15
- 实施
- 2022-09-30
GB/T 451.2 纸和纸板定量的测定 GB/T 14233.2-2005 医用输液、输血、注射器具检验方法 第2部分：生物学试验方法 GB 19192-2003 隐形眼镜护理液卫生要求 YY/T 0681.2-2009 无菌医疗器械包装试验方法 第2部分：软性屏障材料的密封强度 YY/T 0681.14-2018 无菌医疗器械包装试验方法 第14部分：透气包 装材料湿性和干性微生物屏障试验 YY/T 0698.5-2009 最终灭菌医疗器械包装材料 第5部分：透气材料与塑料膜组成的可密封组合袋和卷材 要求和试验方法 YY/T 0698.9-2009 最终灭菌医疗器械包装材料 第9部分:可密封组合袋、卷材和盖材生产用无涂胶聚烯经非织造布材料要求和试验方法
General technical criteria of instruction bags for peracetic acid sterilization
- ICS
- 11.080.30
- CCS
- C2780
- 发布
- 2021-12-14
- 实施
- 2021-12-14
