11.080.01 消毒和灭菌综合 标准查询与下载

GSO ISO 14937:2015 保健品灭菌 医疗器械灭菌过程灭菌材料特性、开发、验证和常规监测的通用要求

1.1 Inclusions 1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products. 1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. 1.1.3 This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. 1.1.4 This International Standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process. NOTE It is not a requirement of this International Standard to have a full quality management system. The necessary elements 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 or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party. 1.2 Exclusions 1.2.1 This International Standard does not apply to sterilization processes that rely solely on physical removal of microorganisms (for example, filtration). 1.2.2 This International Standard does not describe detailed procedures for assessing microbial inactivation. 1.2.3 This International Standard does not specify requirements for characterization of an agent or 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. 1.2.4 This International Standard does not supersede or modify published International Standards for particular sterilization processes.

Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

GSO ISO 11140-5:2015 保健品灭菌化学指标 第5部分：Bowie型和Dick型除气试验2类指标

This part of ISO 11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Additionally, this part of ISO 11140 includes test methods and equipment used to meet these performance requirements.

Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

GSO ISO 14161:2015 保健品灭菌 生物指示剂 选择、使用和解释结果的指南

This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. This International Standard applies to biological indicators for which International Standards exist. NOTE 1 See, for example, the ISO 11138 series. NOTE 2 The general information provided in this International Standard can have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g., new and developing sterilization processes. This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration. This International Standard is not intended to apply to combination processes using, for example, washer disinfectors or flushing and steaming of pipelines. This International Standard is not intended to apply to liquid sterilization processes.

Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results

GSO ISO 11140-3:2015 卫生保健产品灭菌 化学证据 第3部分：鲍伊和迪克蒸汽渗透测试的2级证据系统

This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.

Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

GSO ISO 14160:2015 卫生保健产品的灭菌 利用动物组织及其衍生物的一次性医疗器械的液体化学灭菌剂 灭菌剂的表征、开发、验证和常规控制的要求

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 sterilizati...

GSO ISO 11138-5:2015 保健品灭菌 生物指示剂 第5部分：低温蒸汽和甲醛灭菌工艺的生物指示剂

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937. NOTE 2 Requirements for work place safety may be provided by national or regional regulations.

Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

BS EN ISO 13408-1:2015 保健品的无菌加工 一般要求

Aseptic processing of health care products. General requirements

EN ISO 13408-7:2015 保健品的无菌加工.第7部分:医疗器具及其组合产品的可供选择的处理(ISO 13408-7:2012)

Dieser Teil von ISO 13408 legt Anforderungen an alternative Ansätze zur Verfahrenssimulation für die Qualifizierung der aseptischer Herstellung von Medizinprodukten und Kombinationsprodukten fest, die nicht in der Endverpackung sterilisiert werden können und bei denen der Ansatz für die Verfahrenssimulation nach ISO 13408-1 nicht angewendet werden kann, und stellt einen Leitfaden dafür zur Verfügung. Dieser Teil von ISO 13408 beschreibt, wie die Risikobeurteilung während der Entwicklung eines aseptischen Verfahrens verwendet werden kann, um eine Studie zur Verfahrenssimulation für Medizinprodukte und Kombinationsprodukte in den Fällen zu planen, in denen ein direkten Ersatz des Produktes durch Medien während der aseptischen Herstellung praktisch nicht möglich ist oder nicht das tatsächliche aseptische Verfahren simulieren würde.

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

BS EN ISO 11137-1:2015 医疗保健产品的消毒. 辐射. 医疗器械消毒方法的制定, 确认和常规控制要求

Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices

BS EN ISO 11137-2:2015 保健产品的灭菌.辐射.杀菌剂量的确定

Sterilization of health care products. Radiation. Establishing the sterilization dose

EN ISO 13408-1:2015 保健品的无菌加工.第1部分:通用要求(ISO 13408-1:2008, including Amd 1:2013)

Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an Verfahren, Programme und Verfahrensweisen zur Entwicklung, Validierung und Routinekontrolle des Herstellungsverfahrens für aseptisch hergestellte Produkte für die Gesundheitsfürsorge fest und stellt einen Leitfaden dafür zur Verfügung. Der vorliegende Teil von ISO 13408 umfasst Anforderungen und einen Leitfaden in Bezug auf das Gesamtthema der aseptischen Herstellung. Besondere Anforderungen und ein Leitfaden für verschiedene spezielle Prozesse und Verfahren in Bezug auf Filtration, Lyophilisierung, Technologien der Reinigung vor Ort (en: cleaning in place, CIP), Sterilisation vor Ort (en: sterilization in place, SIP) und Isolatorsysteme sind in anderen Teilen von ISO 13408 angeführt. ANMERKUNG Der vorliegende Teil von ISO 13408 ersetzt keine nationalen behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken (GMP) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale Zuständigkeiten betreffen.

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

YY/T 1302.1-2015 环氧乙烷灭菌的物理和微生物性能要求　第1部分：物理要求

Physical requirements and microbiological performance of ethylene oxide sterilization—Part 1: Physical aspects

YY/T 1302.2-2015 环氧乙烷灭菌的物理和微生物性能要求 第2部分:微生物要求

YY/T 1302的本部分规定了环氧乙烷灭菌微生物方面的过程定义、确认、过程有效性维护等。 本部分适用于医疗器械及其他相关产品或材料的环氧乙烷灭菌过程，为环氧乙烷(EO)灭菌过程的开发和确认中的各种微生物方面问题提供了解决方法。本部分还为采用ISO 11135-1：2007和ISO/TS 11135-2:2008标准的医疗器械制造商(包括使用外包灭菌工厂或外包灭菌操作的制造商)提供额外的应用指南。 YY/T 1302的本部分未包括可能对产品生物负载和灭菌过程有影响的各个因素。

Physical requirements and microbiological performance of ethylene oxide sterilization.Part 2:Microbiological aspects

YY/T 1264-2015 适用于臭氧灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择臭氧灭菌工艺材料适应性提供评价指南。本标准适用于采用臭氧灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to ozone sterilization

YY/T 1267-2015 适用于环氧乙烷灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择环氧乙烷灭菌的材料适应性提供评价指南。 本标准适用于采用环氧乙烷灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to ethylene oxide sterilization

YY/T 1265-2015 适用于湿热灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择湿热灭菌的材料适应性提供评价指南。 本标准适用于采用湿热灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to moist heat sterilization

YY/T 1266-2015 适用于过氧化氢灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择过氧化氢灭菌的材料适应性提供评价指南。本标准适用于采用过氧化氢灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to hydrogen peroxide sterilization

YY/T 1263-2015 适用于干热灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择干热灭菌的材料适应性提供评价指南。本标准适用于采用干热灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to dry heat sterilization

YY/T 1268-2015 环氧乙烷灭菌的产品追加和过程等效

本标准规定追加新产品或有变化的产品于原有确认的环氧乙烷灭菌过程中,使用不同设备时灭菌过程的等效性。本标准适用于经环氧乙烷(EO)灭菌法处理、采用传统放行或参数放行的医疗器械。本标准适用的环氧乙烷灭菌情况包括:a)在已经确认的环氧乙烷灭菌过程中增加新产品;b)评估已确认产品的变更;c)已确认的过程转移到不同的场地或设备;d)评估灭菌过程的等效性。尽管本标准预期应用于医疗器械,但其内容也适用于其他相关的产品或材料。

Product adoption and process equivalence for ethylene oxide sterilization

NF S98-001-1*NF EN ISO 11140-1:2015 卫生保健产品的消毒.化学指示剂.第1部分:一般要求

La présente partie de l'ISO 11140 spécifie les exigences générales et les méthodes d'essai relatives aux indicateurs qui révèlent l'exposition à des procédés de stérilisation par modification physique et/ou chimique de substances, et qui sont utilisés pour contrôler l'obtention d'un ou de plusieurs paramètres spécifiés pour un procédé de stérilisation. Leur action ne dépend pas de la présence ou de l'absence d'un organisme vivant.

Sterilization of health care products - Chemical indicators - Part 1 : general requirements