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
Sterilization; packing materials for sterilizing goods, instrument trays made of metal
Sterilization; packing materials for sterilizing goods, instrument trays made of metal
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 1977-01
- 实施
ISO 11607-1:2006 specifies the 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. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 实施
- 0000-00-00
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022)
- ICS
- 11.080.30
- CCS
- 发布
- 实施
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 实施
- 0000-00-00
ISO 11607-1:2006 specifies the 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. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 实施
- 0000-00-00
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. Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 实施
- 0000-00-00
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 实施
- 0000-00-00
Specifies requirements for single-use non-woven materials made of natural or man-made (synthetic) fibres or their blends intended for use as non-reusable wraps for goods undergoing sterilization in health care facilities.
Packaging of items (sterile) for patient care - Single-use, non-woven wrapping materials - For goods undergoing sterilization in health care facilities
- ICS
- 11.080.30
- CCS
- 发布
- 实施
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022)
- ICS
- 11.080.30
- CCS
- 发布
- 实施
This part of the series of EN 868 provides examples of particular requirements and test methods for heat and self-sealable pouches and reels manufactured from paper complying with EN 868-3 and plastic film complying with clause 4 of this European Standard. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2, 4.3, 4.4, 4.5, 4.6 and 4.7 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. Heat and self-sealable pouches and reels specified in this standard are suitable for use as packaging of medical devices which are to be terminally sterilized. The use of heat and self-sealable pouches and reels as primary packages enables ease of aseptic presentation where it is important for the user to be able to see the contents of the pack before it is opened.
Packaging materials and systems for medical devices which are to be sterilized - Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 实施
- 0000-00-00
