国内外对内镜终末漂洗用水的要求

ICBC

国内外以及各医疗组织对软式内镜终末漂洗用水的要求不尽相同，尤其是对菌落的要求。现将个组织的要求列表如下，供大家参考。

国别/组织	文献	规定	原文
中国	WS 507-2016	≤10 cfu/100ml	纯化水应符合GB 5749的规定，并应保证细菌总数≤10  cfu/100ml
ISO	ISO 5111-2022	≤10 cfu/100ml	At the point of use, the final rinse  water in WD intended to process thermolabile endoscopes should ensure fewer  than 10 CFU/100 ml sample of final  rinse water
ISO	ISO 15883.4-2018	≤10 cfu/100ml	there are less than 10cfu/100ml sample of final rinse water when tested
WGO	WGO Endoscope Disinfection 2023	—	Endoscopes should be thoroughly rinsed  with bacteria-free water after disinfection.
美国	CLSI guidelines C3-A4	＜10 cfu/ml	4.2.2 Microbiological Impurities    The specification for microbial content  of CLRW at the point where the water exits a purification system for use in  the laboratory is a maximum of 10  CFU/mL, measured by the plate count method described in Section 7.2.
美国	AAMI/ST 108-2023	＜10 cfu/ml	The bacteria level for Critical Water in Table 2(<10  CFU/mL) is consistent with the Clinical Laboratory Standards Institute (CLSI)  guidelines.
美国	AAMI/ST91-2021	＜10 cfu/ml	Critical  Water: This water is mainly used for the final  rinse or for steam generation
英国/香港/新加坡	HTM 01-06 E：2016	＜1 cfu/100ml	Satisfactory
		1-9  cfu/100ml	Acceptable – indicates that bacterial  numbers are under a reasonable level of control
		10-100  cfu/100ml	Risk assessment required to investigate  potential problems and super chlorinate or repeat EWD self-disinfect
		＞100 cfu/100ml	Risk assessment required to consider  taking EWD out of service until water quality improved

几点说明：
1. 我国的要求和ISO的要求一样；
2. 大多数欧洲国家也是采用的ISO标准；
3. 美国的标准（＜10 cfu/ml，即：＜1000 cfu/100ml）比ISO标准（≤ 10 cfu/100ml）要低很多；（为啥呢？？？）
4. 香港、新加坡采用的是英国HTM标准。这一标准是分段的；
5. 日本的标准没有找到英文版的；
6. 另附3张图片和参考文献于后，方便大家阅读和查阅原文








参考文献：

1.      WS 507-2016 《软式内镜清洗消毒技术规范》

2.      ISO/TS 5111-2022 Guidance onquality of water for sterilizers, sterilization and washer-disinfectors forhealth care products.

3.      ISO 15883-4:2018 Washer-disinfectorsPart 4: Requirements and tests for washer-disinfectors employing chemicaldisinfection for thermolabile endoscopes.

4.      World Gastroenterology Organization(WGO) Guidelines, Endoscope disinfection update: 2023.

5.      Clinical and LaboratoryStandards Institute. C3-A4 Preparation and Testing of Reagent Water in theClinical Laboratory; Approved Guideline, Fourth Edition.

6.      ANISI/AAMI ST108:2023 Water forthe processing of medical devices.

7.      AAMI ST91-2021 flexible andsemi-rigid endoscope processing in health care facilities.

8.      Health Technical Memorandum(HTM) 01-06:2016 Decontamination of flexible endoscopes Part E: Testing methods

9.      MOH Singapore, the NationalInfection Prevention & Control Guidelines for Endoscopy Centres. 2023.

junior86

方法也很重要，R2A培养5天和普通琼脂培养2天，细菌数能差十几二十倍，还有有没有使用滤膜法。美国的建议再查证下

高山雪莲W

我国的标准与国际标准看齐了。
图表一目了然就能了解国内外内镜终末漂洗用水的标准要求。

ICBC

高山雪莲W 发表于 2024-6-26 11:03
我国的标准与国际标准看齐了。
图表一目了然就能了解国内外内镜终末漂洗用水的标准要求。 ...

我觉得，英国HTM标准值得参考（最后一张，按照红黄橙红分4段控制微生物）

姓陳

整理的很详细，学习了

EMP

junior86 发表于 2024-6-25 16:37
方法也很重要，R2A培养5天和普通琼脂培养2天，细菌数能差十几二十倍，还有有没有使用滤膜法。美国的建议再 ...

实际中应该参照哪个具体的实验条件进行呢？是取100mL，薄膜过滤法，30~35℃培养5天？现在有没有哪一个明确的检验标准？

junior86

EMP 发表于 2024-6-26 18:57
实际中应该参照哪个具体的实验条件进行呢？是取100mL，薄膜过滤法，30~35℃培养5天？现在有没有哪一个明 ...

规范没有给出检测方法，药典2022版纯水是R2A培养基培养的。美国的规范里就有通过第 7.2 节中描述的孔板计数方法测量的描述

ICBC

将ISO的终末漂洗用水的微生物检测方法做了简单的翻译，供参考。以下内容以英语为准

ISO 15883-4:2018

Annex E

(normative)

Tests for microbialcontamination of final rinse water

终末漂洗用水的微生物污染试验

E.1 Principle    Samples of WD  rinse water are inoculated onto appropriate microbiological growth media to  evaluate the microbial quality of the water. The media facilitates the growth  and counting of aerobic mesophilic bacteria, including Pseudomonas aeruginosa, and detection of environmental (atypical)  Mycobacterium sp.	E.1原则    将清洗消毒机漂洗用水的样品接种到适当的微生物生长培养基上，以评估水中的微生物质量。培养基有利于需氧嗜温菌的生长和计数，包括铜绿假单胞菌，以及环境(非典型)分枝杆菌的检测。
E.2  Material    Sampling containers used for collection  of final rinse water shall be 250 ml, or larger, and shall be sterile.	E.2材料    用于收集终末漂洗用水的取样容器应为250毫升或更大，并应无菌。
E.3  Procedure    E.3.1  Sampling technique    Take samples from draw-off points  adjacent to the WD and from the point of discharge into the WD chamber or  load.	E.3过程    E.3.1采样技术    从 WD 附近的取样点以及进入 WD 室或负载的排放口采集样本。
Swab the discharge surfaces of the  sampling points thoroughly with 0.2 μm filtered 70% alcohol and allow to dry by  evaporation immediately before the sample is taken.	用 0.2 μm 过滤的 70% 酒精彻底擦拭取样点的排放口表面，并在采集样本前立即蒸发干燥。
Collect a sample of not less than 200 ml,  or as specified, from each sampling point for each test to be carried out.	对于每次要进行的测试，从每个取样点采集不少于 200 毫升的样品，或按规定采集。
Test the samples within 4 h of collection  or store at 2℃ to 5℃ and test within 48 h of collection.	样品采集后4小时内检测，或2℃~ 5℃保存，采集后48小时内检测。
E.3.2  Test for aerobic mesophilic bacteria    Test final rinse water for aerobic  mesophilic bacteria in accordance with ISO 15883-1:2006+Amd 1:2014. 6.4.2.4, and  Annex D of this document.	E.3.2需氧嗜温菌试验    根据ISO 15883-1:2006+Amd 1:2014的6.4.2.4和本文附件D测试终末漂洗用水中的需氧嗜温细菌。
NOTE   Specific microbiological media can be used for the detection of  certain types of microorganisms (e.g. for Pseudomonas  aeruginosa).	注：特定微生物培养基可用于检测某些类型的微生物(如铜绿假单胞菌)。
E.3.3  Test for environmental (atypical) Mycobacterium  sp.    Filter a 100 ml aliquot of the sample  under vacuum through a 0.2 μm filter that is of appropriate size to allow its transfer and  incubation as described below (e.g. 47 mm diameter).	E.3.3环境(非典型)分枝杆菌试验。    将 100 ml 样品在真空条件下通过适当大小的 0.2 μm 过滤器进行过滤，以便进行如下所述的转移和孵育（例如直径 47 mm）。
Transfer the filter aseptically to the  surface of a Middlebrook * 7H10 Agar plate and incubate at (30 ±2)℃. The plates should be read regularly. Incubation  should be continued for 28 d before it is concluded that no growth has  occurred.    * Equivalent media can be used if they can  be shown to lead to the same results	将滤膜无菌转移至 Middlebrook * 7H10 琼脂平板表面，在 (30 ±2)℃ 下培养。定期读数。培养 28 天后方可判定无生长发生。    * 如果能证明它们会导致相同的结果，则可以使用等效介质
The agar plate should be sealed to  prevent dehydration of the growth medium.	琼脂板应密封，以防止培养基脱水。
Carry out the  test in duplicate. Examine the filters weekly and count and record the number  of colonies of bacterial growth.	试验一式两份。每周检查过滤器，计数并记录细菌生长的菌落数量。
Record the mean  number of colony forming units per sample.	记录每个样品的平均菌落形成单位数。
NOTE If plates are overgrown by  relatively faster growing contaminants within 48 h to 72 h, it might be necessary  to resample and perform a validated preliminary partial decontamination of  the sample with one or more chemicals to which mycobacterial species are more  resistant than the other organisms.	注:如果培养皿在48小时至72小时内被生长相对较快的污染物过度生长，可能需要重新取样，并使用一种或多种分枝杆菌比其他生物更耐药的化学品对样品进行初步的部分去污。
If growth of (atypical) Mycobacterium sp. is observed  consideration should be given to having the cultures transferred to a  specialist laboratory for identification of the mycobacterial strains  isolated.	如果观察到(非典型)分枝杆菌生长，应考虑将培养物转移到专业实验室，以鉴定分离的分枝杆菌菌株。
E.4  Results/Acceptance criteria	E.4结果/验收标准
Record the number of aerobic mesophilic  bacteria per 100 ml sample of final rinse water;	记录每100毫升最终漂洗水样品中需氧嗜温菌的数量;
Report the number of Pseudomonas aeruginosa in 100 ml, and (atypical) Mycobacterium sp. in 100 ml.	报告100毫升中的铜绿假单胞菌的数量，以及100毫升中的（非典型）分枝杆菌属的数量。
There are fewer than 10 CFU/100 ml sample  of final rinse water and the water is free from Pseudomonas aeruginosa in 100 ml, and (atypical) Mycobacterium sp. in 100 ml (see 6.3).	终末冲洗用水样品中的细菌数量少于 10 CFU/100 ml，且 100 ml 水中不含铜绿假单胞菌，以及（非典型）分枝杆菌属（见 6.3）。

zjw600154

整理的很详细，学习了

陈壹千

想问一下，终末漂洗用的纯水，多久需要检测一次？按季度吗？