CN103710163A - 医疗器械的清洗剂和消毒剂 - Google Patents
医疗器械的清洗剂和消毒剂 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/23—Solid substances, e.g. granules, powders, blocks, tablets
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
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- A01N37/16—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group; Thio analogues thereof
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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C—CHEMISTRY; METALLURGY
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Abstract
本发明涉及配制为粉末的用于医疗和/或外科的部件和设备的清洗剂和/或消毒剂。其包含至少一种过氧化物、至少一种用于在水溶液中由过氧化物释放过乙酸的酰化剂以及至少一种非离子表面活性剂。根据本发明,提供包含用于将2%的水溶液的pH值调节到7.5-9的试剂,并且配制为粒料,其中过氧化物和/或酰化剂被非离子表面活性剂包覆。
Description
技术领域
本发明涉及配制为粉末的用于医疗和/或外科的部件和设备的清洗剂和/或消毒剂。其包含至少一种过氧化物、至少一种用于在水溶液中从过氧化物释放过乙酸的酰化剂以及至少一种非离子表面活性剂。
背景技术
医疗和/或外科器械和设备的消毒剂在实践中广泛使用。消毒作用常基于醛类、季铵化合物类、酚类、醇类或其它有效物质。
同样已知的是基于过氧化物,尤其是过乙酸的清洗剂和消毒剂。过氧化物有好的抗微生物作用,但通常仅具有很低的储存稳定性。
发明内容
EP 1
489 908 A1 已经公开了根据权利要求1的前述部分的试剂。相对于该现有技术,本发明的目的是提供一种在本文开头提及的清洗剂和/或消毒剂,其表现出好的储存能力,且在溶解于水中之后快速施展出其完整的作用范围。
根据本发明,该目的通过包含用于将 2%(在本发明范围内的所有数据均为重量%)的水溶液的 pH 值调节到 pH
7.5-9 的试剂并将其配制成粒料来实现,其中用非离子表面活性剂包覆过氧化物和/或酰化剂。
首先解释几个在本发明范围内使用的术语。
术语粉末指包括粒料在内的可分散或可流动的固体。
用于医疗和/或外科的部件和设备的清洗剂和/或消毒剂是这样的试剂,其在处理这类器械的过程中至少减少污物负荷,尤其是病菌负荷。在清洗或消毒内窥镜的过程中本发明尤其适合。
酰化剂是这样的化合物,其在过氧化物的水溶液中可释放过乙酸。其例如可涉及酰氧基羧酸,但尤其是 N-酰基化合物。
用于调节根据本发明所采用的7.5-9的 pH 值的试剂尤其可包含合适的酸和/或缓冲系统。应出现该 pH 值的通常的申请浓度是 2 重量% 的粉末在水中的溶液。根据本发明,可采用并优选的是,在1 %的溶液及在这之间的浓度中也出现该 pH 值。
在本发明范围内,术语粒料指可流动的固体,在其中,过氧化物、酰化剂、任选的也有另外的成分例如用于调节 pH 值的试剂被非离子表面活性剂包覆。这意味着,无论如何相当部分的非离子表面活性剂富集在粒料颗粒的表面。所述包覆可通过合适的且为本领域技术人员所熟悉的方法例如喷涂来进行。本发明所使用的非离子表面活性剂在室温下或者在轻微加热至例如 30-40℃ 后为液体或有足够的可流动性,以能够被喷洒。
根据本发明,所述粒料的颗粒大小优选可在 0.1-2 mm,进一步优选
0.2-1.6 mm,进一步优选 0.4-1.2 mm 的范围。优选至少 80 重量%,进一步优选至少 90 重量%的粒料落在所述各自的大小范围。
外科器械如尤其是内窥镜,在使用后,在使其经受完整的处理循环之前经常首先人工预清洗。通常是经常在使用之后紧接着立即进行预清洗,在预清洗时应尽可能减少病菌负荷,使得对操作该经消毒的器械的人员的危害减少到最低限度。替代地或者额外地,经常也在浸浴中进行人工消毒。
在这两种情况中重要的是,在由该固体调制成相应的水溶液之后快速产生抗微生物作用,即在该水溶液中快速产生游离过乙酸的有效浓度。本发明已认识到,通过用非离子表面活性剂(n-Tensid)包覆粒料将促进粒料的快速崩解和物理溶解过程。将即可使用的稀释溶液中的 pH 值调节到要求的范围 7.5-9 促进酰化剂由过氧化物快速释放足量的过乙酸并因此最晚 15
min 后在该水溶液中存在对于应用目的而言足够的并因此有效的过乙酸浓度。根据本发明,特别优选将 pH 值调节到 7.5-8.5,进一步优选 7.6-7.9的范围。
此外,用非离子表面活性剂包覆粒料有利于使得在储存酰化剂和过氧化物的混合物时发生的分解反应减少到最低限度并因此提高本发明的试剂的储存能力。
因此本发明提供在室温下,优选也在 40℃下的通常储存的情况下,可储存至少一年,优选至少两年的试剂,该试剂在溶解于水中后快速(在15
min内)提供有效浓度的游离过乙酸。本发明试剂在水溶液中的典型使用浓度为 1 或 2 重量%。典型地,在1%的溶液中,在 15 min 后,产生至少 900 ppm,典型约1500 ppm 的游离过乙酸的浓度。在2%的溶液中,其为至少 2600 ppm,典型地为 3000 ppm。
作为过氧化物,根据本发明优选使用无机过氧化物如特别是过硼酸盐或过碳酸盐。优选钠盐。特别优选过碳酸钠。根据本发明可以并优选,所使用的过氧化物在混合前同样具有包衣,以在与酰化剂一起储存时使不希望的分解反应减少到最低限度。例如,所述过氧化物可具有油酸盐/酯-硫酸钠-包衣。
根据本发明,所述酰化剂可选自四乙酰乙二胺 (TAED)、四乙酰甘脲和二乙酰六氢三嗪二酮。四乙酰乙二胺
(TAED)是特别优选的。
根据本发明,所述非离子表面活性剂可选自脂肪醇乙氧基化物、脂肪醇丙氧基化物、EO-PO-嵌段共聚物、烷基葡糖苷、烷基多葡糖苷、辛基酚乙氧基化物和壬基酚乙氧基化物。本领域技术人员熟悉的乙氧基化脂肪醇是特别优选的。
作为用于调节 pH 值的试剂优选采用酸和/或缓冲系统。特别优选的是柠檬酸(优选无水酐)、柠檬酸盐缓冲液、磷酸盐-或碳酸盐缓冲液。根据本发明,例如可将柠檬酸与磷酸盐,优选三聚磷酸钠组合。
本发明的试剂配制为固体。其优选是基本上无水的,以使得过氧化物的分解反应减少到最低限度并且提高储存稳定性。过氧化物、酰化剂和用于调节 pH 值的试剂的质量比例的总和优选为本发明试剂总质量的至少 60 重量%,进一步优选至少 70 重量%,进一步优选至少 80 重量%,进一步优选至少 90 重量%。该总和例如可以为该试剂总质量的95 重量%。
在本发明范围内,基于配制成固体的试剂的总质量计,优选的是以下的内容物重量比例:
- 过氧化物 40 – 70,优选 50 – 60 重量%;
- 酰化剂 15 – 40,优选 20 – 30 重量%,
- 用于调节 pH 值的试剂 5 – 25 重量%,优选 10 – 20 重量%,
- 非离子表面活性剂 1 – 5 重量%,优选 2 – 4 重量%。
此外,本发明的主题是用于制备本发明试剂的方法。在该方法中,首先将过氧化物、酰化剂和用于调节 pH 值的试剂(任选地也有可选的另外的内容物)彼此混合。随后在喷射液体非离子表面活性剂的情况下制粒。所述包覆例如可借助于旋转喷射混合器进行。根据本发明可使用的典型喷射参数是 4
bar 的喷射压力和 175 g/s的喷射功率。
上文中提及的可选的另外的添加物例如可以是酶,尤其是蛋白水解酶,另外的表面活性剂或这一类的。这些内容物可有利于改善本发明的试剂的清洗能力。
此外,本发明的主题是用于清洗和消毒医疗和/或外科器械和/或设备(尤其是内窥镜)的方法,该方法包括下述步骤:
a)制备根据权利要求1-9的任一项的清洗剂和/或消毒剂的 0.5-3%的,优选 1-2%的水溶液,
b)清洗和/或消毒医疗和/或外科器械和设备。
使用浓度取决于所预定的使用目的。如果仅进行预清洗以减少病菌负荷,则可以例如在 1 %的溶液中消毒 5 min 时间足以。如果意在进行完全的清洗和消毒 (优选人工进行),根据本发明则优选例如选择 2 %的浸浴清洗和消毒 15 min 的时间。
根据本发明,其优选在浸浴中进行。
在人工使用时,在使用期间该溶液的温度优选在约 20℃(室温) - 40℃。
所述清洗或消毒优选进行 5-30 min,进一步优选
10-20 min的时间。
具体实施方式
以下描述本发明的实施例。
实施例1
为制备本发明的清洗剂和消毒剂,以给出的重量比使用下述的原材料:
重量% | |
过碳酸钠 (Harke Chemicals) | 55.0 |
TAED (Peractive® P, Clariant) | 25.0 |
三聚磷酸钠 (袋装商品,粗 850 – 1100,BK Giulini) | 2.0 |
柠檬酸酐 | 15.0 |
PPG-4 Laureth-5 (脂肪醇 C10/12, 5 EO/4 PO, Cognis) | 3.0 |
在搅拌下,将所述粉末成分 (除非离子表面活性剂之外的所有成分)加入到旋转混合器中并均匀混合。将所述非离子表面活性剂加热到 40℃并在 4
min 内在 4 bar的喷射压力下,在连续地进一步混合下喷射在所述粉末混合物上。然后进一步混合约 12
min 。
实施例2
如按实施例1进行,所用原材料如下:
重量% | |
过碳酸钠 ( Harke Chemicals) | 49.0 |
TAED (Peractive® AN,具有油酸盐/酯-硫酸钠-包衣的过氧化物,Clariant) | 29.0 |
三聚磷酸钠 (袋装商品, 粗 850 – 1100,BK Giulini) | 4.0 |
柠檬酸酐 | 12.0 |
Dehypon® GRA (改性脂肪醇聚二醇醚,Fa. BASF) | 4.0 |
碳酸钾 (无水,约 95%的) | 2.0 |
在本实施例中使用另一种非离子表面活性剂,并且通过使用碳酸钾改性缓冲系统。
实施例3
如按实施例1进行,所用原材料如下:
重量% | |
过碳酸钠 ( Harke Chemicals) | 50.0 |
TAED (Peractive® AN,具有油酸盐/酯-硫酸钠-包衣的过氧化物,Clariant) | 29.0 |
三聚磷酸钠 (袋装商品,粗 850 – 1100,BK Giulini) | 3.0 |
柠檬酸酐 | 15.0 |
脂肪醇 C10, 11 EO (Lutensol® ON110, BASF) | 3.0 |
在本实施例中使用另一种非离子表面活性剂。
实施例4
按实施例1进行,所用原材料如下:
重量% | |
过碳酸钠 ( Harke Chemicals) | 50.0 |
TAED (Peractive® AN,具有油酸盐/酯-硫酸钠-包衣的过氧化物,Clariant) | 29.0 |
益瑞蛋白酶(Esperase) (Novozymes) | 1.0 |
柠檬酸酐 | 15.0 |
脂肪醇 C10/12, !0 EO (Dehypon® LS 104 l,BASF) | 2.0 |
碳酸钾 (无水,约 95%的) | 3.0 |
在本实施例中又使用另一种非离子表面活性剂,此外另外包含一种蛋白水解酶。
实施例5
在本实施例中进行预清洗或预消毒(如下进行部分消毒,使得对随后操作内窥镜的人的沾污危险减少至最低限度)。
在清洗槽内,在温热的水中制备实施例 1 的试剂的 1 重量% 的溶液。在 15 min 之后产生约 1500
ppm 浓度的游离过乙酸。根据本发明该浓度应尽可能为或高于 900 ppm。
在检查之后立即还在检查室中用无绒布擦拭内窥镜 (其尚连接在光源和抽气泵上)。应避免有机残余物在其上干燥。然后将内窥镜浸入该溶液中并多次冲洗和抽吸所有的通道。将内窥镜与光源和抽吸装置分离,关闭清洗槽并运送到处理室中。
实施例6
在本实施例中,进行内窥镜的人工清洗和消毒。
在清洗槽内,在温热的水中制备实施例 1 的试剂的 2 重量% 的溶液。在 15 min 之后产生约 3000
ppm 浓度的游离过乙酸。将内窥镜或辅助器械(Zusatzinstrument)如此置于该溶液中,使得所有表面均被完全润湿且不存在气泡。所有的清洗步骤均在液体表面以下进行。用刷子小心地清洗内窥镜通道,其中注意内窥镜生产商的说明,使用对于每个通道而言合适的经消毒的刷子。为冲洗该应用的溶液,可在每种情况中使用新鲜的无微生物的水,其中必须仔细冲洗内窥镜的所有通道和外壳(Außenmantel)。
实施例7
对于有效消毒而言重要的是,在由本发明的试剂调制成溶液后迅速产生足够的游离过乙酸浓度并在该溶液中保持较长的使用时间。
在自来水中制备实施例 1 的试剂的 2 重量% 的溶液(在 25℃下搅拌15 min)。测定溶液中游离过乙酸的浓度,以表2中给出的时间间隔重复该测定。可看出,在配制溶液后立即产生有效浓度且经通常 8 h 的使用时间后仍保持了有效浓度。
表 2
时间 [h] | 过乙酸 [ppm] |
0 | 3345 |
1 | 2991 |
2 | 2631 |
3 | 2564 |
4 | 2354 |
5 | 2106 |
6 | 2054 |
7 | 1880 |
8 | 1591 |
实施例8
为检验本发明试剂的储存能力,在每种情况中将 2 kg 实施例 1 的粉末装入 3 l 的桶中(聚丙烯)并用盖子将该桶封闭。将如此制得的样品曝露在下述不同的储存条件下总共12周的时间:
- 6℃,55% 相对湿度
- 21℃,55% 相对湿度
- 30℃,70% 相对湿度
- 40℃,75% 相对湿度
- 交变气候 6℃、21℃、40℃、21℃、6℃ 各 5h,其中各温度之间的过渡时间各 1 h。
在储存 4、8 和 12 周之后研究每种样品的粉末或粒料外观,和由其制成 2%的水溶液、该溶液的 pH值和在该溶液中的游离过乙酸的浓度。
在所有样品中和所有储存条件下得到如下结果:
所述粒料保持了其最初的白-浅黄色的颜色和可流动性。该水溶液是清澈无色的。在搅拌 15 min 后,水溶液中游离过乙酸的浓度为 2600 - 3000 ppm。所述溶液的 pH 值为 7.6 – 7.8。
该储存实验支持这样的结论,在室温下,本发明的试剂可储存至少 2 年。
实施例9
在本实施例中,研究本发明的试剂的清洗效果。本发明的首要目的是,通过在水溶液中释放游离过乙酸来起到消毒的作用。过乙酸广泛而良好的消毒效果是现有技术中早已知晓的。
此外,本发明的试剂应以有利的方式同样有助于清洗。下面进行的浸泡实验意在定量其清洗能力。如此设计本实验(仅浸在溶液中而没有在被污染的面上施加直接的机械作用),以至于不可能并因此也不能期待完全去除试验污物。
作为污物载体使用粗糙的小金属片 5 x 10 cm 。将200
µl 除去纤维蛋白的绵羊血( Acila Ch. B.
24632)施加在经清洗和称重的小金属片上并在室温下过夜干燥。 然后称重这些实验小片。
在 600 ml 的烧杯中制备500 g 2%的实施例 1 的水溶液。在实验进行期间,在室温下用磁力搅拌器(8级)搅拌该溶液。
将所述实验小片在该溶液中浸泡 15 min ,随后通过浸入去离子水中来简单漂洗。在过夜干燥后,重新称重这些实验小片。
实验后,残留在实验小片上的试验污物的残余量为 48.6 重量%。在为进行比较而测试的市售用于内窥镜的消毒剂的情况中,该残余量明显更高 (最高到 96.9 重量%)。这表明,本发明的试剂不仅产生良好的消毒作用,而且肯定有助于清洗。
Claims (15)
1.配制为粉末的用于医疗和/或外科的器械和设备的清洗剂和/或消毒剂,其包含:
a)至少一种过氧化物,
b)至少一种酰化剂,其用于在水溶液中由过氧化物释放过乙酸,
c)至少一种非离子表面活性剂,
其特征在于:
d)其包含用于将 2%的水溶液的 pH 值调节到 pH 7.5-9 的试剂,
e)其配制为粒料,其中用非离子表面活性剂包覆过氧化物和/或酰化剂。
2.根据权利要求1的清洗剂和/或消毒剂,其特征在于,所述过氧化物包括过硼酸盐和/或过碳酸盐。
3.根据权利要求1或2的清洗剂和/或消毒剂,其特征在于,所述酰化剂选自四乙酰乙二胺 (TAED)、四乙酰甘脲和二乙酰六氢三嗪二酮。
4.根据权利要求1-3任一项的清洗剂和/或消毒剂,其特征在于,所述非离子表面活性剂选自脂肪醇乙氧基化物、脂肪醇丙氧基化物、EO-PO-嵌段共聚物、烷基葡糖苷、烷基多葡糖苷、辛基酚乙氧基化物和壬基酚乙氧基化物。
5.根据权利要求 1-4任一项的清洗剂和/或消毒剂,其特征在于,其包含酸和/或缓冲系统作为用于调节 pH 值的试剂。
6.根据权利要求5的清洗剂和/或消毒剂,其特征在于,其包含柠檬酸和/或磷酸盐-或碳酸盐缓冲液作为用于调节 pH 值的试剂。
7.根据权利要求6的清洗剂和/或消毒剂,其特征在于,其包含三聚磷酸钠作为磷酸盐缓冲液。
8.根据权利要求1-7任一项的清洗剂和/或消毒剂,其特征在于,过氧化物、酰化剂和用于调节 pH 值的试剂的总和为所述清洗剂和/或消毒剂总质量的至少 60 重量%,进一步优选至少 70 重量%,进一步优选至少 80 重量%,进一步优选至少 90 重量%。
9.根据权利要求1-8任一项的清洗剂和/或消毒剂,其特征在于下述内容物的重量比:
- 过氧化物 40-70,优选 50–60 重量%;
- 酰化剂 15–40,优选 20–30 重量%,
- 用于调节 pH 值的试剂5–25 重量%,优选 10 – 20 重量%,
- 非离子表面活性剂 1–5 重量%,优选 2–4 重量%。
10.用于制备根据权利要求1-9任一项的清洗剂和/或消毒剂的方法,其特征在于下述步骤:
a)将过氧化物、酰化剂和用于调节 pH 值的试剂混合,
b)在喷射非离子表面活性剂的情况下进行造粒。
11.用于清洗和/或消毒医疗和/或外科器械和设备的方法,其特征在于下述步骤:
a)制备根据权利要求1-9的任一项的清洗剂和/或消毒剂的 0.5-3%的,优选 1-2%的水溶液,
b)清洗和/或消毒医疗和/或外科器械和设备。
12.根据权利要求11 的方法,其特征在于,所述清洗和/或消毒在浸浴中进行。
13.根据权利要求11 或12 的方法,其特征在于,所述清洗和/或消毒在 20-40℃下进行。
14.根据权利要求11 - 13 任一项的方法,其特征在于,所述清洗和/或消毒进行 5-30 min,优选 10-20 min的时间。
15.根据权利要求11 - 14 任一项的方法,其特征在于,所述清洗和/或消毒以人工进行。
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CN104621180A (zh) * | 2015-02-02 | 2015-05-20 | 山东威高药业股份有限公司 | 一种新型消毒灭菌粉 |
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GB2531246A (en) | 2014-10-07 | 2016-04-20 | Peracide Uk Ltd | Disinfectant wipe dispenser |
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AU2022249170A1 (en) * | 2021-04-01 | 2023-10-12 | Sterilex, Llc | Quat-free powdered disinfectant/sanitizer |
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- 2013-07-29 AU AU2013209372A patent/AU2013209372A1/en not_active Abandoned
- 2013-07-30 RU RU2013135663/15A patent/RU2598350C2/ru active
- 2013-07-31 BR BR102013019428-0A patent/BR102013019428A2/pt not_active Application Discontinuation
- 2013-07-31 JP JP2013158475A patent/JP2014031513A/ja active Pending
- 2013-08-01 US US13/956,751 patent/US20140039051A1/en not_active Abandoned
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CN102165053A (zh) * | 2008-09-24 | 2011-08-24 | 埃科莱布有限公司 | 粒状清洁和消毒组合物 |
Cited By (11)
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CN104621180A (zh) * | 2015-02-02 | 2015-05-20 | 山东威高药业股份有限公司 | 一种新型消毒灭菌粉 |
CN109789230A (zh) * | 2016-09-28 | 2019-05-21 | 美涤威公司 | 用于制备高水平消毒剂的设备和方法 |
CN109803688A (zh) * | 2016-09-28 | 2019-05-24 | 美涤威公司 | 用于使用固体高水平消毒化学物质产生消毒液的系统和方法 |
CN109789230B (zh) * | 2016-09-28 | 2021-01-08 | 美涤威公司 | 用于制备高水平消毒剂的设备和方法 |
CN107596417A (zh) * | 2017-09-26 | 2018-01-19 | 北京健租宝科技有限公司 | 一种医疗器械的消毒方法和消毒液及其制备方法 |
CN107875425A (zh) * | 2017-11-27 | 2018-04-06 | 中国人民解放军陆军防化学院 | 设施内部空间的消毒方法 |
CN107875425B (zh) * | 2017-11-27 | 2020-06-30 | 中国人民解放军陆军防化学院 | 设施内部空间的消毒方法 |
CN113166682A (zh) * | 2018-09-27 | 2021-07-23 | 丹尼斯科美国公司 | 用于医疗器械清洁的组合物 |
CN109136950A (zh) * | 2018-09-28 | 2019-01-04 | 天津圳鹏清洗技术开发有限公司 | 用于医疗器械和设备的清洗剂 |
CN109392903A (zh) * | 2018-11-02 | 2019-03-01 | 广东环凯微生物科技有限公司 | 一种过氧羧酸消毒液及其制备方法 |
CN109392903B (zh) * | 2018-11-02 | 2021-04-06 | 广东环凯微生物科技有限公司 | 一种过氧羧酸消毒液及其制备方法 |
Also Published As
Publication number | Publication date |
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EP2692844A1 (de) | 2014-02-05 |
RU2598350C2 (ru) | 2016-09-20 |
BR102013019428A2 (pt) | 2015-01-06 |
RU2013135663A (ru) | 2015-02-10 |
JP2014031513A (ja) | 2014-02-20 |
AU2013209372A1 (en) | 2014-02-20 |
US20140039051A1 (en) | 2014-02-06 |
CA2822187A1 (en) | 2014-02-01 |
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