11.080.30 消毒封装 标准查询与下载
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Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2006-07-01
- 实施
- 2006-07-05
This standard specifies the requirements for 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.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) English version of DIN EN ISO 11607-2:2006-07
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2006-07
- 实施
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
- ICS
- 11.080.30
- CCS
- 发布
- 2006-06-30
- 实施
- 2006-06-30
This part of ISO 11607 specifies the requirements for 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.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- 发布
- 2006-06-28
- 实施
- 2006-06-28
ISO 11607-2:2006 specifies the requirements for 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. ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also 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
- C47
- 发布
- 2006-05-31
- 实施
- 2006-05-31
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
- 2006-05-31
- 实施
- 2006-05-31
This part of ISO 11607 specifies the requirements for 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.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
- ICS
- 11.080.30
- CCS
- 发布
- 2006-04-01
- 实施
This part of ISO 11607 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 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. This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2006-04
- 实施
This part of ISO 11607 specifies the requirements for 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2006-04
- 实施
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 to the point of use.
Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2005-12-23
- 实施
Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2005-12-23
- 实施
Establishes requirements and provides guidance for the selection of an appropriate Sterility Assurance Level (SAL) for terminally sterilized medical devices labeled "sterile." Also establishes acceptance criteria for maximum contamination rates for aseptically-filled products labeled "sterile."
Sterilization of Health Care Products - Requirements for products labeled "STERILE"
- ICS
- 11.080.30
- CCS
- C04
- 发布
- 2003-12-18
- 实施
Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven wrapping material, paper bags and heat and self-sealable pouches and reels
- ICS
- 11.080.30
- CCS
- C48
- 发布
- 2003-10
- 实施
Specifies the requirements and test methods for packaging materials and systems that are used for packaging of medical devices which are to be terminally sterilized and which are intended to maintain sterility of the device.
Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods
- ICS
- 11.080.30
- CCS
- 发布
- 2003-07-18
- 实施
- 2003-07-18
Packaging for terminally sterilized medical devices
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2003-02
- 实施
Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants
- ICS
- 11.080.30
- CCS
- 发布
- 2003
- 实施
- 2004-01-01
Packaging for terminally sterilized medical devices. General requirements
- ICS
- 11.080.30
- CCS
- 发布
- 2003
- 实施
- 2004-01-01
Sterilization - Sterile supply - Part 9: Handling of sterilization container
- ICS
- 11.080.30
- CCS
- C48
- 发布
- 2002-10
- 实施
Standard Guide for Accelerated Aging of Sterile Medical Device Packages
- ICS
- 11.080.30
- CCS
- 发布
- 2002-01-10
- 实施
Specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin.
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants
- ICS
- 11.080.30
- CCS
- 发布
- 2002
- 实施
