美标：AAMI ST108医疗器械处理用水

ICBC

AAMI TIR 34经过修改，已经被AAMI ST108所替代，成为正式的美国标准。现将其目录和前言部分分享大家

Water for the processing of medical devices

Contents

1．Scope

2．Normative references

3．Terms and definitions

4．Roles and responsibilities

5．Risk analysis

6．Categories of water quality for medical device processing

7．Water quality selection and requirements

8．Water treatment systems installation and operationqualification

9．Water treatment systems performance qualification - evaluationof water quality

10．Water treatment systems routine monitoring

11．Continuous quality improvement

12．Water treatment systems maintenance

13．Special considerations

Annex A (informative) Guidance on the application ofthe normative requirements

Annex B (informative) Risk analysis

Annex C (informative) Automated Endoscope Reprocessor(AER)

Annex D (informative) Water used in cleaning and moistheat processes

Annex E (informative) Water treatment technologies

Annex F (informative) Water treatment system design

Annex G (informative) Routine monitoring of watertreatment equipment & produced water quality

Annoy H (informative) Maintaining microbiologicalquality

Annex I (informative) Typical presentation of waterquality issues during the processing of medical devices Bibliography

Introduction

Water quality is an important considerationin all stages of medical device processing, as is the purity or chemicalcontent of the steam that is generated for moist heat sterilization. The healthcare facility should have a multidisciplinary team in place that develops astrategy to confirm all aspects of water quality that impact the processing ofmedical devices within this standard. Appropriate water quality and steampurity in device processing requires collaboration between the personnel whoprocess medical devices and the personnel who establish and maintain the watertreatment system.

Water treatment and delivery systems can beconfigured in many ways to achieve the required water quality specifications.Water can be treated by a variety of methods that yield different levels ofwater quality. Gram-negative bacteria and nontuberculous mycobacteria can growin water regardless of treatment process. The rate of growth and the microbiallevels attained are a function of several factors related to the water (e.g.,variety and concentration of organic contaminants, pH, temperature). Watersystems that are closely monitored for quality reduce variability of processingconditions and effectiveness of cleaning and disinfection processes as well asreduce the potential of microbial proliferation. The importance of monitoringwater quality to prevent problems with microbial proliferation cannot beoveremphasized.

This standard defines multiple levels ofwater quality and steam purity suitable for medical device processing, and itdescribes the water treatment processes that can be utilized in order toproduce water of the quality to meet each of these categories.

1  Scope

1.1  General

This standard establishes minimumrequirements for the water quality used at different stages in the processingof medical devices (e.g., reusable devices and single-use devices providednon-sterile requiring processing prior to use such as non-sterile implants andprocessed single-use devices) to make them ready for use on the next patient.These requirements are established to assist medical device processingprofessionals in the selection of the appropriate water quality needed forcleaning, rinsing, disinfection, and sterilization of medical devices.

1.2  Inclusions

This standard covers the quality of thewater delivered to the point-of-use and used in medical device processing(cleaning, rinsing, disinfection and sterilization). It defines water typesbased on the qualities possessed and where it will be used. Included in thisdocument are:

a) Responsibility for the water management program;

b) Importance of water quality;

c) Adverse effects of water impurities on medical device processing;

d) Categories and requirements of water quality for medical deviceprocessing;

e) Selection of water of the appropriate quality;

f) Purity requirements of water used to generate steam;

g) Effective water treatment and qualification;

h) Considerations for ongoing maintenance, monitoring and qualityimprovement of the water treatment system;

i) Troubleshooting water quality issues.

This standard also provides definitions ofterms and a bibliography.

1.3  Exclusions

This standard does not cover:

a) Waterrequirements for hemodialysis applications;

b) Waterrequirements for laboratory use;

c) Steamquality requirements (i.e., physical qualities of steam such as: moisturecontent, noncondensable gas content and Superheat). See ANSI/AAMI ST79 ;

d) Watertreatment performed within the medical device processing equipment (e.g.,washers, washer/disinfectors, or automated endoscope reprocessors (AERs);

e) Waterquality of municipal water supply; and

f) Testingof water post use.

缭绕

谢谢！
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医疗器械加工用水
内容
1.适用范围
2.规范性参考
3.术语和定义
4.角色和职责
5.风险分析
6.医疗器械加工水质类别
7.水质选择及要求
8.水处理系统安装运行资质
9.水处理系统性能鉴定-水质评价
10.水处理系统日常监测
11.持续的质量改进
12.水处理系统维护
13.特殊注意事项
附件A（信息性） 关于适用规范性要求的指导意见
附件B（信息性） 风险分析
附录C（信息性）自动内窥镜再处理器（AER）
附件D（信息性）清洁和湿热过程中使用的水
附件E（资料） 水处理技术
附录F（信息性） 水处理系统设计
附件G（信息性）水处理设备和采出水质量的常规监测
烦恼H（信息量） 保持微生物质量
附件一（信息性） 医疗器械加工过程中水质问题的典型表现 参考书目

介绍
在医疗器械加工的所有阶段，水质都是一个重要的考虑因素，湿热灭菌产生的蒸汽的纯度或化学成分也是如此。医疗机构应有一个多学科团队，以制定战略，以确认影响本标准范围内医疗器械加工的水质的各个方面。设备加工中适当的水质和蒸汽纯度需要处理医疗器械的人员与建立和维护水处理系统的人员之间的协作。
水处理和输送系统可以通过多种方式进行配置，以达到所需的水质规格。水可以通过多种方法进行处理，从而产生不同水平的水质。革兰氏阴性菌和非结核分枝杆菌可生长

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在医疗器械加工的所有阶段，水质都是一个重要的考虑因素，湿热灭菌产生的蒸汽的纯度或化学成分也是如此。医疗机构应有一个多学科团队，以制定战略，以确认影响本标准范围内医疗器械加工的水质的各个方面。设备加工中适当的水质和蒸汽纯度需要处理医疗器械的人员与建立和维护水处理系统的人员之间的协作。 水处理和输送系统可以通过多种方式进行配置，以达到所需的水质规格。水可以通过多种方法进行处理，从而产生不同水平的水质。革兰氏阴性菌和非结核分枝杆菌可生长

jerkran

老师，同意下我好友申请，谢谢         

jerkran

Water for the processing of medical devices
医疗器械加工用水
Contents 内容
1．Scope 1.适用范围
2．Normative references 2.规范性参考
3．Terms and definitions 3.术语和定义
4．Roles and responsibilities
4.角色和职责
5．Risk analysis 5.风险分析
6．Categories of water quality for medical device processing
6.医疗器械加工用水的类别
7．Water quality selection and requirements
7.水质选择及要求
8．Water treatment systems installation and operationqualification
8.水处理系统安装运行资质
9．Water treatment systems performance qualification - evaluationof water quality
9.水处理系统性能鉴定-水质评价
10．Water treatment systems routine monitoring
10.水处理系统常规监测
11．Continuous quality improvement
11.持续的质量改进
12．Water treatment systems maintenance
12.水处理系统维护
13．Special considerations
13.特殊注意事项
Annex A (informative) Guidance on the application ofthe normative requirements
附件A（信息性） 关于适用规范性要求的指导意见
Annex B (informative) Risk analysis
附件B（信息性） 风险分析
Annex C (informative) Automated Endoscope Reprocessor(AER)
附录C（信息性）自动内窥镜再处理器（AER）
Annex D (informative) Water used in cleaning and moistheat processes
附件D（信息性）清洁和湿热过程中使用的水
Annex E (informative) Water treatment technologies
附件E（信息） 水处理技术
Annex F (informative) Water treatment system design
附录F（信息性） 水处理系统设计
Annex G (informative) Routine monitoring of watertreatment equipment & produced water quality
附件G（信息性）水处理设备和采出水质量的常规监测
Annoy H (informative) Maintaining microbiologicalquality
烦恼H（信息量） 保持微生物质量
Annex I (informative) Typical presentation of waterquality issues during the processing of medical devices Bibliography
附件一（信息性） 医疗器械加工过程中水质问题的典型表现 参考书目


Introduction 介绍
Water quality is an important considerationin all stages of medical device processing, as is the purity or chemicalcontent of the steam that is generated for moist heat sterilization.
在医疗器械加工的所有阶段，水质都是一个重要的考虑因素，湿热灭菌产生的蒸汽的纯度或化学成分也是如此。
The healthcare facility should have a multidisciplinary team in place that develops astrategy to confirm all aspects of water quality that impact the processing ofmedical devices within this standard.
医疗机构应有一个多学科团队，以制定战略，以确认影响本标准范围内医疗器械加工的水质的各个方面。
Appropriate water quality and steampurity in device processing requires collaboration between the personnel whoprocess medical devices and the personnel who establish and maintain the watertreatment system.
设备加工中适当的水质和蒸汽纯度需要处理医疗器械的人员与建立和维护水处理系统的人员之间的协作。
Water treatment and delivery systems can beconfigured in many ways to achieve the required water quality specifications.Water can be treated by a variety of methods that yield different levels ofwater quality.
水处理和输送系统可以通过多种方式进行配置，以达到所需的水质规格。水可以通过多种方法进行处理，从而产生不同水平的水质。
Gram-negative bacteria and nontuberculous mycobacteria can growin water regardless of treatment process.
革兰氏阴性菌和非结核分枝杆菌无论处理过程如何，都可以在水中生长。
The rate of growth and the microbiallevels attained are a function of several factors related to the water (e.g.,variety and concentration of organic contaminants, pH, temperature).
生长速率和达到的微生物水平是与水相关的几个因素（例如，有机污染物的种类和浓度，pH值，温度）的函数。
Watersystems that are closely monitored for quality reduce variability of processingconditions and effectiveness of cleaning and disinfection processes as well asreduce the potential of microbial proliferation.
密切监测质量的水系统可减少加工条件的变化以及清洁和消毒过程的有效性，并减少微生物扩散的可能性。
The importance of monitoringwater quality to prevent problems with microbial proliferation cannot beoveremphasized.
监测水质以防止微生物扩散问题的重要性怎么强调都不为过。
This standard defines multiple levels ofwater quality and steam purity suitable for medical device processing, and itdescribes the water treatment processes that can be utilized in order toproduce water of the quality to meet each of these categories.
该标准定义了适用于医疗器械加工的多个级别的水质和蒸汽纯度，并描述了可用于生产满足这些类别中每个类别的质量水的水的水处理过程。
1  Scope 1 范围
1.1  General 1.1 概述
This standard establishes minimumrequirements for the water quality used at different stages in the processingof medical devices (e.g., reusable devices and single-use devices providednon-sterile requiring processing prior to use such as non-sterile implants andprocessed single-use devices) to make them ready for use on the next patient.These requirements are established to assist medical device processingprofessionals in the selection of the appropriate water quality needed forcleaning, rinsing, disinfection, and sterilization of medical devices.
本标准规定了医疗器械加工不同阶段使用的水质的最低要求（例如，可重复使用的器械和一次性设备，提供非无菌设备，在使用前需要处理的非无菌设备，如非无菌植入物和加工过的一次性设备），以使其准备用于下一个患者。制定这些要求是为了帮助医疗器械加工专业人员选择医疗器械清洁、冲洗、消毒和灭菌所需的适当水质。
1.2  Inclusions 1.2 内含物
This standard covers the quality of thewater delivered to the point-of-use and used in medical device processing(cleaning, rinsing, disinfection and sterilization). It defines water typesbased on the qualities possessed and where it will be used. Included in thisdocument are:
本标准涵盖了输送到使用点和用于医疗器械加工（清洁，漂洗，消毒和灭菌）的水的质量。它根据拥有的品质和使用地点来定义水的类型。本文档包括：
a) Responsibility for the water management program;
a） 负责水管理计划;
b) Importance of water quality;
b） 水质的重要性;
c) Adverse effects of water impurities on medical device processing;
c） 水杂质对医疗器械加工的不利影响;
d) Categories and requirements of water quality for medical deviceprocessing;
d） 医疗器械加工用水的类别和要求;
e) Selection of water of the appropriate quality;
e） 选择适当质量的水;
f) Purity requirements of water used to generate steam;
f） 用于产生蒸汽的水的纯度要求;
g) Effective water treatment and qualification;
g） 有效的水处理和鉴定;
h) Considerations for ongoing maintenance, monitoring and qualityimprovement of the water treatment system;
h） 对水处理系统的持续维护、监测和质量改进的考虑;
i) Troubleshooting water quality issues.
i） 解决水质问题。
This standard also provides definitions ofterms and a bibliography.
本标准还提供了术语定义和参考书目。
1.3  Exclusions 1.3 排除
This standard does not cover:
本标准不包括：
a) Waterrequirements for hemodialysis applications;
a） 血液透析应用的用水需求;
b) Waterrequirements for laboratory use;
b） 实验室用水需求;
c) Steamquality requirements (i.e., physical qualities of steam such as: moisturecontent, noncondensable gas content and Superheat). See ANSI/AAMI ST79 ;
c） 蒸汽质量要求（即蒸汽的物理质量，例如：水分含量、不凝性气体含量和过热度）。参见 ANSI/AAMI ST79 ;
d) Watertreatment performed within the medical device processing equipment (e.g.,washers, washer/disinfectors, or automated endoscope reprocessors (AERs);
d） 在医疗器械加工设备（例如，清洗机、清洗机/消毒器或自动内窥镜再处理器 （AER））内进行的水处理;
e) Waterquality of municipal water supply; and
e） 市政供水的水质;和
f) Testingof water post use.
f） 水后使用测试。