11.080.01 消毒和灭菌综合 标准查询与下载
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This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.This International Standard covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see Note 1).This International Standard is not applicable to material of human origin.This
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
- ICS
- 11.080.01
- CCS
- 发布
- 2011-09-30
- 实施
- 2011-09-30
ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
Aseptic processing of health care products - Part 1: General requirements
- ICS
- 11.080.01
- CCS
- 发布
- 2011-09-25
- 实施
- 2011-09-25
ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).
Aseptic processing of health care products - Part 2: Filtration
- ICS
- 11.080.01
- CCS
- 发布
- 2011-09-04
- 实施
- 2011-09-04
ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.
Aseptic processing of health care products - Part 3: Lyophilization
- ICS
- 11.080.01
- CCS
- 发布
- 2011-09-04
- 实施
- 2011-09-04
ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. ISO 13408-4:2005 does not supersede or replace national regulatory requirement
Aseptic processing of health care products - Part 4: Clean-in-place technologies
- ICS
- 11.080.01
- CCS
- 发布
- 2011-09-04
- 实施
- 2011-09-04
ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.
Aseptic processing of health care products - Part 5: Sterilization in place
- ICS
- 11.080.01
- CCS
- 发布
- 2011-09-04
- 实施
- 2011-09-04
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
Aseptic processing of health care products - Part 6: Isolator systems
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- 11.080.01
- CCS
- 发布
- 2011-09-04
- 实施
- 2011-09-04
Aseptic processing of health care products - Part 6 : isolator systems.
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- 11.080.01
- CCS
- C47
- 发布
- 2011-09-01
- 实施
- 2011-09-17
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices.
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09-01
- 实施
- 2011-09-17
Aseptic processing of health care products - Part 2 : filtration.
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09-01
- 实施
- 2011-09-17
Aseptic processing of health care products - Part 1 : general requirements.
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09-01
- 实施
- 2011-09-17
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version EN ISO 13408-1:2011
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09
- 实施
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009); German version EN ISO 25424:2011
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- 11.080.01
- CCS
- C47
- 发布
- 2011-09
- 实施
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005); German version EN ISO 13408-6:2011
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09
- 实施
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09
- 实施
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09
- 实施
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006); German version EN ISO 13408-5:2011
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-09
- 实施
1.1 Inclusions 1.1.1 This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. 1.1.2 This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1) 1.1.3 This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only. 1.2 Exclusions 1.2.1 Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. 1.2.2 This standard does not specify requirements for designating a medical device as “STERILE”. Such requirements are given in EN 556-1. 1.2.3 This standard does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.2 of EN ISO 14937:2000. 1.2.4 This standard does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. NOTE 1 Safety requirements for sterilizers are specified in EN 61010-2-040. NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements. 1.2.5 This European Standard does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. NOTE 1 Attention is drawn to EN 14180. NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation specifying limits for the level of formaldehyde residues on medical devices and products. 1.2.6 This European Standard does not cover preparatory measures that may be necessary before sterilization such as cleaning, disinfection and packing. NOTE For re-sterilizable medical devices, the manufacturer(s) of these devices should supply information on the preparatory measures (see EN ISO 17664).
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-08-31
- 实施
- 2011-08-31
This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. This International Standard covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see Note 1). This International Standard is not applicable to material of human origin. This International Standard does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see Note 2). This International Standard does not describe methods for validation of the inactivation or elimination of protozoa and parasites. The requirements for validation and routine control described in this International Standard are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see Note 4). This International Standard does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see Note 5). This International Standard does not cover the level of residual sterilizing agent within medical devices (see Note 6). This International Standard does not describe a quality management system for the control of all stages of manufacture (see Note 7). NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1, is important. NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this International Standard does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2. NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3. NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a defined sterilization process. NOTE 5 Such testing is a crucial part of the design and development of a medical device. NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents. NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization proc
- ICS
- 11.080.01
- CCS
- C10
- 发布
- 2011-07-31
- 实施
- 2011-07-31
ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- 发布
- 2011-07-31
- 实施
- 2011-07-31
