11.080.01 消毒和灭菌综合 标准查询与下载

CAN/CSA-Z11135-2015 保健品灭菌 环氧乙烷 医疗器械灭菌过程开发、验证和常规控制要求（第一版）

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (First Edition)

ASTM E1173-15 评估手术前, 导管插入术前或注射前皮肤处理的标准试验方法

5.1 These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting in reducing significantly the number of organisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, to maintain reductions for an extended time. 1.1 The test method is designed to measure the reduction of the microflora of the skin. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3.1 Exception—In this test method, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses. 1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).2 1.5 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

GSO ISO 11137-2:2014 保健品灭菌辐射 第2部分：灭菌剂量的测定

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

GSO ISO 13408-2:2014 无菌保健品的制备 第2部分：过滤

This part of ISO 13408 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. This part of ISO 13408 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

GSO ISO 13408-4:2014 医疗保健产品灭菌器的准备 第4部分：原位清洁技术

This part of ISO 13408 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. This part of ISO 13408 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. This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer. This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

Aseptic processing of health care products -- part 4 : clean-in-place technologies

GSO ISO 11137-1:2014 保健品灭菌辐射 第1部分：医疗器械灭菌过程准备、验证和常规监测要求

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator. ISO 11137-1:2006 does not: specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease; detail specified requirements for designating a medical device as sterile; specify a quality management system for the control of all stages of production of medical devices; specify requirements for occupational safety associated with the design and operation of irradiation facilities; specify requirements for the sterilization of used or reprocessed devices.

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

GSO ISO 11135:2014 保健品灭菌环氧乙烷医疗器械灭菌过程的制备、验证和常规监测

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices

GSO ISO 17665-1:2014 保健品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、验证和常规控制要求

1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to: a) saturated steam venting systems; b) saturated steam active air removal systems; c) air steam mixtures; d) water spray; e) water immersion. NOTE See also Annex E. 1.2 Exclusions 1.2.1 This part of ISO 17665 does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.2 This part of ISO 17665 does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent. 1.2.3 This part of ISO 17665 does not detail a specified requirement for designating a medical device as “sterile.” NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.4 This part of ISO 17665 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 part of ISO 17665 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party. 1.2.5 This part of ISO 17665 does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities. NOTE Requirements for operational safety are specified in IEC 61010-2-040. Additionally, safety regulations exist in some countries.

Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

GSO ISO 13408-5:2014 医疗保健产品灭菌器的准备 第5部分：现场灭菌

1.1 This part of ISO 13408 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. NOTE SIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steam sterilization in place, which is the most common method used, is given in . 1.2 This part of ISO 13408 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product. 1.3 This part of ISO 13408 does not apply to processes where equipment is dismantled and delivered to a sterilizer. 1.4 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regional jurisdictions. 1.5 This part of ISO 13408 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.

Aseptic processing of health care products -- part 5 : sterilization in place

GSO ISO 17664:2014 医疗器械灭菌 制造商为医疗器械处理过程提供的信息

This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor. This standard specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification. Requirements are specified for processing that consists of all or some of the following activities: — preparation at the point of use; — preparation, cleaning, disinfection; — drying; — inspection, maintenance and testing; — packaging; — sterilization; — storage. When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing. It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards. In this case, a reference in the instructions is all that is required. For those medical devices where instructions for use are not required to accompany the medical device, other means of communicating the information can be used, e.g. user manuals, symbols or wall charts supplied separately. This standard excludes textile devices used in patient draping systems or surgical clothing. NOTE The principles of this standard may be applied when considering the information to be supplied with medical devices which only require disinfection prior to re-use.

Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices

GSO ISO 13408-1:2014 保健品灭菌器的制备 第1部分：一般要求

1.1 This part of ISO 13408 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. 1.2 This part of ISO 13408 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. NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional jurisdictions.

Aseptic processing of health care products -- part 1 : general requirements

GSO ISO 13408-3:2014 无菌保健品的制备 第3部分：冷冻干燥

This part of ISO 13408 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

KS P ISO 11135-1:2014 保健品灭菌 环氧乙烷

Sterilization of health care products — Ethylene oxide

KS P ISO TS 11135-2-2014 保健品灭菌环氧乙烷第2部分:ISO 11135－1应用指南

Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135－1

KS P ISO 11135-1-2014 保健品灭菌.环氧乙烷

Sterilization of health care products — Ethylene oxide

KS P ISO 11137-2:2014 保健·医疗灭菌 辐射 第2部分：灭菌剂量的选定

Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose

KS P ISO TS 11135-2:2014 保健品的灭菌.环氧乙烷.第2部分：KS P ISO 11135－1的适用指南

Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135－1

BS EN ISO 11140-1:2014 保健产品的灭菌.化学指示剂.一般要求

Sterilization of health care products. Chemical indicators. General requirements

ASTM E1837-96(2014) 确定可重复使用医疗器械消毒过程功效的标准测试方法（模拟使用测试）

1.1 This test method is intended to describe a procedure for testing the effectiveness of a disinfection process for reprocessing reusable medical devices when it is tested with a challenge of vegetative cells including mycobacteria. Disinfection normally deals with testing activity against vegetative cells of bacteria, viruses, and fungi. Since this test method is process oriented, the user may wish to examine a variety of test organisms. 1.2 This test method is designed to provide a reproducible procedure to verify the effectiveness of a previously validated disinfectant or disinfection procedure for reusable medical instruments and devices. 1.3 This test method is not meant to define the effectiveness of or validation of the particular disinfection process used or its kinetics, but rather, it is devised to confirm the effectiveness of the disinfection process by simulating use situations with a particular test process using medical devices and instruments. Either manual or machine reprocessing can be tested. 1 This test method is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents. Current edition approved Oct. 1, 2014. Published December 2014. Originally approved in 1996. Last previous edition approved in 2007 as E1837 – 96(2007). DOI: 10.1520/E1837-96R14. 2 The boldface numbers in parentheses refer to the list of references at the end of this standard. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 1 1.4 This test method is intended for use with reusable cleaned and previously sterilized or disinfected (high level) medical instruments and devices. Endoscopes are described in this test method as a worst-case example for contamination and sampling. The selected sterilization or disinfection processes, or both, should have been validated previously, as well as the effectiveness of rinsing for residual sterilant/disinfectant removal determined. 1.5 An inoculum with high numbers of selected microorganisms is applied to both test and control, cleaned and sterilized, or disinfected medical instruments. Strains of microorganisms with a recorded resistance to disinfectants are used to contaminate the instrument sites known or suspected to be the most difficult to reprocess. 1.6 It is impractical to test for recovery of survivors by immersion of some instruments, for example, endoscopes or some laproscopic instruments, in growth medium because of complexity, size, difficulty in long-term incubation, or deterious effects resulting from incubation. Elution of organisms from the inoculated surfaces, therefore, may be performed to estimate the number of recoverable organisms. Immersion can be used for smaller instruments. 1.7 Control instruments are inoculated in the same manner as the test instruments and elution or immersion methods are performed to determine the number of organisms recoverable from the instrument. For channeled devices, such as endoscopes testing, the number of organisms recoverable from the instrument (inside and outside) will serve as the initial control count. It is expected that some fraction of the number of organisms inoculated will be lost in the process of inoculation/ drying. 1.8 A testing procedure can be performed on a complete reprocessing cycle or can be limited to just the cleaning or disinfection portions of the cycle whether reprocessing is done in a machine or manually. 1.9 After the test cycle has been completed, remaining inoculated bacteria will be recovered from test instruments using the same elution procedures as for the control instruments. 1.10 Efficacy of a disinfection cycle or reprocessing cycle, or any part thereof, may be determined by comparison of the number of microorganisms recovered from the control instrument (initial recoverable control count) to the recovery determined for the test instruments. 1.11 A knowledge of microbiological techniques is required to conduct these procedures.3 1.12 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)

JIS T 0806-2:2014 保健产品的灭菌.辐射.第2部分:杀菌剂量的确定

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose