外科和麻醉器械等清洗消毒器檢測

外科和麻醉器械等清洗消毒器檢測項(xiàng)目報(bào)價(jià)？??解決方案？??檢測周期？??樣品要求？

點(diǎn) 擊 解 答??

GB 18278.1-2015醫(yī)療保健產(chǎn)品滅菌 濕熱 第1部分:醫(yī)療器械滅菌過程的開發(fā)、確認(rèn)和常規(guī)控制要求

GB 18278的本部分規(guī)定了醫(yī)療器械濕熱滅菌的開發(fā)、確認(rèn)和常規(guī)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(tǒng)；b)　飽和蒸汽-動力排氣系統(tǒng)；c)　空氣蒸汽混合氣體；d)　水噴淋；e)　水浸沒。本部分未規(guī)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(fā)、確認(rèn)和常規(guī)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(guī)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(biāo)示“無菌”醫(yī)療器械的特定要求。本部分未規(guī)定控制醫(yī)療器械生產(chǎn)的所有階段的質(zhì)量管理體系。本部分未規(guī)定與濕熱滅菌設(shè)施的設(shè)計(jì)和運(yùn)行相關(guān)的職業(yè)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(yàn)

YY/T 0734的本部分規(guī)定了自動控制的清洗消毒器及其附件的術(shù)語和定義、通用要求、試驗(yàn)方法、標(biāo)志與使用說明書、包裝、運(yùn)輸和貯存等。本部分適用于對可重復(fù)使用的醫(yī)療器械和對醫(yī)療機(jī)構(gòu)等領(lǐng)域的物品進(jìn)行清潔和消毒的清洗消毒器。處理特殊負(fù)載的清洗消毒器的要求和試驗(yàn)由YY/T 0734的其他部分或其他標(biāo)準(zhǔn)規(guī)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(jìn)行濕熱消毒的清洗消毒器 要求和試驗(yàn)

YY/T 0734的本部分規(guī)定了預(yù)期在單一工作周期對可重復(fù)使用醫(yī)療器械，例如外科器械、麻醉器械等進(jìn)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(guī)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(jìn)行濕熱消毒的清洗消毒器 要求和試驗(yàn)

YY/T 0734的本部分規(guī)定了采用單個(gè)工作周期對盛接人體廢棄物容器進(jìn)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(guī)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(yī)療器械進(jìn)行濕熱消毒的清洗消毒器要求和試驗(yàn)

YY/T 0734的本部分規(guī)定了對非介入式等醫(yī)療器械進(jìn)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(dá)到消毒保證水平(Λ<下標(biāo)0>值不低于60)。同時(shí)，清洗過程關(guān)鍵工藝參數(shù)的自動記錄不要求獨(dú)立的記錄系統(tǒng)。本部分要求與YY/T 0734.1-2009中規(guī)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(fù)用醫(yī)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(nèi)鏡清洗消毒器，本部分規(guī)定進(jìn)行處理的醫(yī)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(yī)療器械的材料評價(jià)

本標(biāo)準(zhǔn)規(guī)定了材料選擇、設(shè)計(jì)和加工、材料試驗(yàn)。為選擇濕熱滅菌的材料適應(yīng)性提供評價(jià)指南。本標(biāo)準(zhǔn)適用于采用濕熱滅菌的醫(yī)療器械的材料評價(jià)。

YY/T 1309-2016清洗消毒器 超聲清洗的要求和試驗(yàn)

本標(biāo)準(zhǔn)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(guī)定了超聲清洗的專用要求。本標(biāo)準(zhǔn)要求與YY/T 0734.1、YY/T 0734.2中規(guī)定的要求合并使用。

YY/T 1495-2016清洗消毒效果的微生物驗(yàn)證方法

本標(biāo)準(zhǔn)規(guī)定了一種驗(yàn)證清洗消毒效果的微生物試驗(yàn)方法。本標(biāo)準(zhǔn)適用于對外科和麻醉器械等醫(yī)療器械進(jìn)行濕熱消毒的清洗消毒器，不適用于采用化學(xué)消毒方式且消毒對象不耐熱的清洗消毒器。

WS/T 367-2012醫(yī)療機(jī)構(gòu)消毒技術(shù)規(guī)范

本標(biāo)準(zhǔn)規(guī)定了醫(yī)療機(jī)構(gòu)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(jiān)測等。本標(biāo)準(zhǔn)適用于各級各類醫(yī)療機(jī)構(gòu)。

GSO ISO 15883-2-2013清洗消毒器第2部分：外科器械、麻醉設(shè)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(yàn)。

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(jìn)行濕熱消毒的清洗消毒器要求和試驗(yàn)

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.

DIN EN ISO 15883-1-2014清洗消毒器.第1部分:一般要求,術(shù)語,定義和試驗(yàn)(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(shè)備,碗,碟,接收器,器具,玻璃器具等進(jìn)行熱消毒的清洗消毒器的試驗(yàn)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(guān)鍵醫(yī)療設(shè)備和保健設(shè)備用的利用熱消毒的墊圈-消毒器具的試驗(yàn)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(chǎn)品的滅菌.輻射.第1部分:醫(yī)療器件消毒過程的制定、確認(rèn)和常規(guī)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.

BS EN ISO 15883-2-2009洗滌消毒器.對外科器具,麻醉設(shè)備,碗,碟,收集器,器皿,玻璃器具等進(jìn)行熱物消毒的洗滌消毒器的試驗(yàn)方法和要求

To be read in conjunction with BS EN ISO 15883-1

BS EN ISO 15883-3-2009洗滌消毒器.對人類廢棄物容器進(jìn)行熱消毒的洗滌消毒器的試驗(yàn)和要求

To be read in conjunction with BS EN ISO 15883-1