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Information on Stainless Steel Surfaces in Steam Sterilizers(Phase 8)

Date: 2023.10.16

5.摘要

Summary

  鉴于大量的影响参数和由此产生的复杂相互关系,以及不同影响因素的平行效应,负责消毒设备的人员往往发现在实践中很难确定实际导致腔室内部不锈钢表面(不希望的或麻烦的)改变的具体原因。

   In light of the large number of influencing parameters and the resulting complex interrelations, and because of the parallel effects of different influencing factors, individuals in charge of sanitizing equipment often find it very difficult in practice to determine the specific cause that has actually led to an (undesired or bothersome) alteration of the stainless steel surfaces located in the interior of a chamber.

  本手册的目的是描述并说明被称为红锈的消毒器室表面变化的现象。还描述了在实际中成功实施的措施。在所有所涵盖的方法中,设备用户、设备制造商和专业清洁公司之间的积极和专注的协作是一个恒定的要求。 

     The aim of this brochure is to describe and identify the phenomenon known as rouging as a change in the surfaces of sterilizer chambers. Measures which have already been successfully implemented in practice are also described. In all of the methods covered, an active and focused collaboration between equipment users, the equipment manufacturer and the specialist cleaning company is a constant requirement.

术语和缩写

Begriffserklärungen und Abkürzungen

德国仪器再处理工作组

访问www.a-k-i.org获取详细信息和免费下载工作组的手册。

A

AKI

German Instrument Reprocessing Workgroup

Visit www.a-k-i.org for detailed information and free downloads of the Workgroup's brochures.

活化

使用酸去除表面的氧化物杂质(不纯物)

Activation

Use of acids to remove oxide impurities on surfaces.

光谱分析技术,用于测定材料表面化学成分的无损研究。

AUGER

Spectroscopic analytical technique used in the non-destructive study of material surfaces to determine their chemical composition.

AUGER(俄歇)

一种不锈钢合金,其中金属原子在有序金属晶格体系中具有面中心立方排列。当熔融材料凝固时,建立了单独的系统,单位晶体总是以不同的方向生长。

Austenitic

A stainless steel alloy in which the metal atoms have a face-centred cubic arrangement in the ordered metal lattice system. The individual system is established when the molten material solidifies, with the unit crystals always growing in different directional orientations.

氯化物=氯化物,元素氯离子

C

Cl =Chloride, ions of the element chlorine

腐蚀

是指发生在材料表面作为(不希望的)一种化学反应的一部分变化的术语。在严重的情况下,这基本上会导致材料/部件的破坏。

Corrosion

Term referring to changes occurring on the surface of a material as part of an (undesired) chemical reaction. In serious cases, this can essentially result in the destruction of the material/component.

=元素铬

Cr = the element chromium

CSSD = central sterile services department, new term MPPU

CSSD=中央无菌服务部门,新术语MPPU

去离子水

来自水处理领域的术语。没有标准的水质水平。去离子水通常是指离子交换脱后电导率小于5µS/cm的产品水。

D

Deionised water

Term from the field of water treatment. Level of water quality that is not standardised. Deionised water typically refers to product water with an electrical conductance of less than 5 µS/cm following ion exchange demineralisation.

能量色散x射线分析作为一种化学分析方法。

E

EDX

Energy dispersive X-ray analysis as a method of chemical analysis.

EDX

用于化学分析的电子光谱学。

ESCA

Electron spectroscopy for chemical analysis.

ESCA

乙二胺四乙酸或乙二胺四乙酸形成金属配合物,然后表现出期望的效果。用于溶解表面上的残留物。

EDTA

Ethylenediamine tetraacetic acid or ethylenediamine tetraacetate Forms metal complexes which then exhibit the desired effect. Used to dissolve residues on surfaces.

铁素体

在有序金属晶格中具有以体为中心的立方金属原子排列的不锈钢合金。

F

Ferritic

Stainless steel alloy with a body-centred cubic metal atom arrangement in the ordered metal lattice.

=元素铁

Fe = the element iron

GLDA=谷氨酸二乙酸四钠络合剂,也被称为螯合剂,是与金属离子形成螯合配合物的化合物。它们会导致不需要的金属离子(铁离子)的掩盖(键合)。

G

GLDA = tetrasodium glutamate diacetate Complexing agents, also known as chelating agents, are chemical compounds which form chelate complexes with metal ions. They result in a masking (bonding) of undesired metal ions (iron ions).

混合离子交换床

阳离子和阴离子交换树脂的混合物。这种混合物通过离子交换从水中去除所有的盐(矿物质、分离的水成分)。

M

Mixed-bed ion exchange

Mixture of cation and anion exchange resin. This mixture removes all salts (mineral, dissociated water constituents) from the water as it passes through the ion exchange.

马氏体

在硬化过程中持续产生的一种合金的晶体结构。在附随的金属晶格中金属原子的排列通常是四面体的。

Martensitic

Crystalline structure of an alloy that consistently occurs during hardening. The metal atom arrangement in the accompanying metal crystal lattice is usually tetrahedral.

形态结构

在不锈钢合金表面的合金元素的精确配置的描述

Morphological structure

Description of the precise configuration of the alloying elements on the surface of the stainless steel alloy.

医疗产品加工单元

MPPU

Medical products processing unit

次氮基三乙酸

用于处理/清洗无污钢表面的化学品。金属络合剂。

N

NTA

Nitrilotriacetic acid

Chemical used for treating/cleaning stain- less steel surfaces. A metal complexing agent.

=元素镍

Ni = the element nickel

氧化

一般来说,氧化本质上是任何化学发生增加的化学反应,也是涉及氧气的化学过程,通常与表面的破坏和锈的形成有关。

O

Oxidation

Generally speaking, oxidation is essentially any chemical reaction in which an increase in valence occurs, and is also a chemical process involving oxygen, usually in connection with damage to / destruction of a surface and rust formation.

欧洲药典

P

Ph. EUR

European Pharmacopoeia (Europäische Pharmakopöe

点蚀

一种通常由氯离子引起特殊(局部)类型的腐蚀。

Pitting

A specific (local) type of corrosion, usually caused by chloride ions.

Ra=算术平均粗糙度值,根据DIN EN ISO 4287规定的表面粗糙度参数

R

Ra = Arithmetical mean roughness value, a surface roughness parameter according to DIN EN ISO 4287

Rz=平均粗糙度深度,根据DINENISO4287规定的表面粗糙度参数

Rz = Mean roughness depth, a surface roughness parameter according to DIN EN ISO 4287

红锈,生锈

最初是一个用来表示红色化妆色调的法语术语。在此用途是指在腔室或腔室表面发现的红褐色膜层/变色(腐蚀)。

Rouge, Rouging

Originally a French term used to denote the application of red make-up hues. Used in this context to refer to the reddish-brown films/discolourations (corrosion) found in chambers or on chamber surfaces.

硅氧化物

含硅酸的水成分的分类术语。这些物质可能是造成不需要的变色膜层的部分原因。

S

Silica

Categorical term for water constituents containing silicic acid. These substances can be partially responsible for undesired coloured films.

硅氧化物的突破

表示在生产处理水时使用混合床离子交换时没完全去除氧化硅化合物。

Silica breakthrough

Denotes the incomplete removal of silica compounds during the use of mixed-bed ion exchanges in the production of treated water.

钢,腐蚀/不锈钢是含有一种铁和其他符合DIN EN 1002010027-1/210088的规格,且在一定条件下不会生锈的元素(铬、镍、钼等)的高级合金。

Steel, non-corroding / stainless steel is a high-grade alloy of iron and other (Cr, Ni, Mo, etc.) elements that meets the specifications of DIN EN 10020, 10027-1/2 and 10088 and will not rust under certain conditions.

超纯水

指满足蒸汽灭菌要求的完全脱盐水。没有从任何特定的标准中定义的质量概念。

U

Ultrapure water

Refers to fully demineralised water which satisfies the requirements for steam sterilization. Not a defined quality concept from any specific standard.

美国药典

USP

United States Pharmacopeia

WD=清洗机消毒器

W

WD = Washer-disinfector


来自:德国钱伯斯工作组(德语缩写:AKK)的手册

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