外科和麻醉器械等清洗消毒器检测

发布时间：2024-06-21 作者：中析研究所浏览：

GB 18278.1-2015医疗保健产品灭菌湿热第1部分:医疗器械灭菌过程的开发、确认和常规控制要求

GB 18278的本部分规定了医疗器械湿热灭菌的开发、确认和常规控制的要求。本部分包含以下湿热灭菌过程，但不限于此：a)　饱和蒸汽-重力排气系统；b)　饱和蒸汽-动力排气系统；c)　空气蒸汽混合气体；d)　水喷淋；e)　水浸没。本部分未规定对海绵状脑病(如羊痒症、牛海绵状脑病和克雅症)病原体灭活过程的开发、确认和常规控制的要求。对于处理潜在受这些病原体污染的材料，某些制定了特殊的规范。本部分不适用于以湿热和其他灭菌剂(如：甲醛)组合作为灭菌因子的灭菌过程。本部分未详述标示“无菌”医疗器械的特定要求。本部分未规定控制医疗器械生产的所有阶段的质量管理体系。本部分未规定与湿热灭菌设施的设计和运行相关的职业安全要求。

YY/T 0734.1-2018清洗消毒器第1部分:通用要求和试验

YY/T 0734的本部分规定了自动控制的清洗消毒器及其附件的术语和定义、通用要求、试验方法、标志与使用说明书、包装、运输和贮存等。本部分适用于对可重复使用的医疗器械和对医疗机构等领域的物品进行清洁和消毒的清洗消毒器。处理特殊负载的清洗消毒器的要求和试验由YY/T 0734的其他部分或其他标准规定。

YY/T 0734.2-2018清洗消毒器第2部分:对外科和麻醉器械等进行湿热消毒的清洗消毒器要求和试验

YY/T 0734的本部分规定了预期在单一工作周期对可重复使用医疗器械，例如外科器械、麻醉器械等进行清洗和湿热消毒的清洗消毒器的专用要求。本部分要求与YY/T 0734.1—2018中规定的通用要求合并使用。

YY/T 0734.3-2018清洗消毒器第3部分:对人体废弃物容器进行湿热消毒的清洗消毒器要求和试验

YY/T 0734的本部分规定了采用单个工作周期对盛接人体废弃物容器进行清空、冲洗、清洁和湿热消毒的清洗消毒器的专用要求。本部分要求与YY/T 0734.1-2018中规定的通用要求合并使用。

YY/T 0734.4-2016清洗消毒器第4部分:对非介入式等医疗器械进行湿热消毒的清洗消毒器要求和试验

YY/T 0734的本部分规定了对非介入式等医疗器械进行湿热消毒的清洗消毒器的特殊要求。此类清洗消毒器可确保通过清洁和湿热消毒达到消毒保证水平(Λ<下标0>值不低于60)。同时，清洗过程关键工艺参数的自动记录不要求独立的记录系统。本部分要求与YY/T 0734.1-2009中规定的通用要求合并使用。本部分要求的清洗消毒器适用于非介入式(即，非穿透皮肤或非接触黏膜表面)等复用医疗器械的清洗和消毒。本部分的要求不适用于YY/T 0734.2,YY/T 0734.3范围中定义的清洗消毒器，也不适用于内镜清洗消毒器，本部分规定进行处理的医疗器械不包括动力器械、管腔器械和其他介入器械。

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。

YY/T 1309-2016清洗消毒器超声清洗的要求和试验

本标准适用于具有自动超声清洗功能且符合YY/T 0734.1、YY/T 0734.2要求的清洗消毒器，规定了超声清洗的专用要求。本标准要求与YY/T 0734.1、YY/T 0734.2中规定的要求合并使用。

YY/T 1495-2016清洗消毒效果的微生物验证方法

本标准规定了一种验证清洗消毒效果的微生物试验方法。本标准适用于对外科和麻醉器械等医疗器械进行湿热消毒的清洗消毒器，不适用于采用化学消毒方式且消毒对象不耐热的清洗消毒器。

WS/T 367-2012医疗机构消毒技术规范

本标准规定了医疗机构消毒的管理要求；消毒与灭菌的基本原则；清洗与清洁、消毒与灭菌方法,清洁、消毒与灭菌的效果监测等。本标准适用于各级各类医疗机构。

GSO ISO 15883-2-2013清洗消毒器第2部分：外科器械、麻醉设备、碗、碟、接收器、器具、玻璃器皿等采用热消毒的清洗消毒器的要求和试验。

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1. The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation.

TS EN ISO 15883-2-2012清洗消毒器. 第2部分: 对外科和麻醉器械等进行湿热消毒的清洗消毒器要求和试验

DIN EN ISO 15883-1-2014清洗消毒器.第1部分:一般要求,术语,定义和试验(ISO 15883-1-2006+Amd 1-2014).德文版本EN ISO 15883-1-2009+A1-2014

This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.

DIN EN ISO 15883-2-2009清洗消毒器.第3部分:对外科器械,麻醉设备,碗,碟,接收器,器具,玻璃器具等进行热消毒的清洗消毒器的试验方法和要求(ISO 15883-2-2006).英文版本DIN EN ISO 15883-2-2006

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended foruse for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such assurgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination ofthe two.The requirements specified in this part of ISO 15883 are applicable in conjunction with the generalrequirements specified in ISO 15883-1.The specified performance requirements of this part of IS~ 15883 may not ensure the inactivation or removalof the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.NOTE 2 If it is considered that priori protein can be present, particular care is needed in the choice of disinfectants andcleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit itsremoval or inactivation.

DIN EN ISO 15883-6-2016清洗消毒器.第6部分:非侵入式,非关键医疗设备和保健设备用的利用热消毒的垫圈-消毒器具的试验和要求(ISO 15883-6-2011).德文版本EN ISO 15883-6-2015

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces). NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two.

DIN EN ISO 17665-1-2006保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认和常规控制的要求(ISO 17665-1:2006)

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.