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外科和麻醉器械等清洗消毒器檢測

發布日期： 2024-06-21 17:34:53 - 更新時間：2024年06月29日 15:22

外科和麻醉器械等清洗消毒器檢測項目報價？??解決方案？??檢測周期？??樣品要求？

GB 18278.1-2015醫療保健產品滅菌濕熱第1部分:醫療器械滅菌過程的開發、確認和常規控制要求

GB 18278的本部分規定了醫療器械濕熱滅菌的開發、確認和常規控制的要求。本部分包含以下濕熱滅菌過程，但不限于此：a)　飽和蒸汽-重力排氣系統；b)　飽和蒸汽-動力排氣系統；c)　空氣蒸汽混合氣體；d)　水噴淋；e)　水浸沒。本部分未規定對海綿狀腦病(如羊癢癥、牛海綿狀腦病和克雅癥)病原體滅活過程的開發、確認和常規控制的要求。對于處理潛在受這些病原體污染的材料，某些制定了特殊的規范。本部分不適用于以濕熱和其他滅菌劑(如：甲醛)組合作為滅菌因子的滅菌過程。本部分未詳述標示“無菌”醫療器械的特定要求。本部分未規定控制醫療器械生產的所有階段的質量管理體系。本部分未規定與濕熱滅菌設施的設計和運行相關的職業安全要求。

YY/T 0734.1-2018清洗消毒器第1部分:通用要求和試驗

YY/T 0734的本部分規定了自動控制的清洗消毒器及其附件的術語和定義、通用要求、試驗方法、標志與使用說明書、包裝、運輸和貯存等。本部分適用于對可重復使用的醫療器械和對醫療機構等領域的物品進行清潔和消毒的清洗消毒器。處理特殊負載的清洗消毒器的要求和試驗由YY/T 0734的其他部分或其他標準規定。

YY/T 0734.2-2018清洗消毒器第2部分:對外科和麻醉器械等進行濕熱消毒的清洗消毒器要求和試驗

YY/T 0734的本部分規定了預期在單一工作周期對可重復使用醫療器械，例如外科器械、麻醉器械等進行清洗和濕熱消毒的清洗消毒器的專用要求。本部分要求與YY/T 0734.1—2018中規定的通用要求合并使用。

YY/T 0734.3-2018清洗消毒器第3部分:對人體廢棄物容器進行濕熱消毒的清洗消毒器要求和試驗

YY/T 0734的本部分規定了采用單個工作周期對盛接人體廢棄物容器進行清空、沖洗、清潔和濕熱消毒的清洗消毒器的專用要求。本部分要求與YY/T 0734.1-2018中規定的通用要求合并使用。

YY/T 0734.4-2016清洗消毒器第4部分:對非介入式等醫療器械進行濕熱消毒的清洗消毒器要求和試驗

YY/T 0734的本部分規定了對非介入式等醫療器械進行濕熱消毒的清洗消毒器的特殊要求。此類清洗消毒器可確保通過清潔和濕熱消毒達到消毒保證水平(Λ<下標0>值不低于60)。同時，清洗過程關鍵工藝參數的自動記錄不要求獨立的記錄系統。本部分要求與YY/T 0734.1-2009中規定的通用要求合并使用。本部分要求的清洗消毒器適用于非介入式(即，非穿透皮膚或非接觸黏膜表面)等復用醫療器械的清洗和消毒。本部分的要求不適用于YY/T 0734.2,YY/T 0734.3范圍中定義的清洗消毒器，也不適用于內鏡清洗消毒器，本部分規定進行處理的醫療器械不包括動力器械、管腔器械和其他介入器械。

YY/T 1265-2015適用于濕熱滅菌的醫療器械的材料評價

本標準規定了材料選擇、設計和加工、材料試驗。為選擇濕熱滅菌的材料適應性提供評價指南。本標準適用于采用濕熱滅菌的醫療器械的材料評價。

YY/T 1309-2016清洗消毒器超聲清洗的要求和試驗

本標準適用于具有自動超聲清洗功能且符合YY/T 0734.1、YY/T 0734.2要求的清洗消毒器，規定了超聲清洗的專用要求。本標準要求與YY/T 0734.1、YY/T 0734.2中規定的要求合并使用。

YY/T 1495-2016清洗消毒效果的微生物驗證方法

本標準規定了一種驗證清洗消毒效果的微生物試驗方法。本標準適用于對外科和麻醉器械等醫療器械進行濕熱消毒的清洗消毒器，不適用于采用化學消毒方式且消毒對象不耐熱的清洗消毒器。

WS/T 367-2012醫療機構消毒技術規范

本標準規定了醫療機構消毒的管理要求；消毒與滅菌的基本原則；清洗與清潔、消毒與滅菌方法,清潔、消毒與滅菌的效果監測等。本標準適用于各級各類醫療機構。

GSO ISO 15883-2-2013清洗消毒器第2部分：外科器械、麻醉設備、碗、碟、接收器、器具、玻璃器皿等采用熱消毒的清洗消毒器的要求和試驗。

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: 對外科和麻醉器械等進行濕熱消毒的清洗消毒器要求和試驗

DIN EN ISO 15883-1-2014清洗消毒器.第1部分:一般要求,術語,定義和試驗(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:對外科器械,麻醉設備,碗,碟,接收器,器具,玻璃器具等進行熱消毒的清洗消毒器的試驗方法和要求(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,非關鍵醫療設備和保健設備用的利用熱消毒的墊圈-消毒器具的試驗和要求(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保健產品的滅菌.輻射.第1部分:醫療器件消毒過程的制定、確認和常規控制的要求(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.