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WS/T 655-2019

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标准编号: WS/T 655-2019 (WS/T655-2019)
中文名称: 呼吸机安全管理
英文名称: Safety management for lung ventilator
行业: 卫生行业标准 (推荐)
中标分类: C05
发布日期: 2019-10-18
实施日期: 2020-05-01
归口单位: 卫生健康委员会
标准依据: 国卫通(2019)13号

WS/T 655-2019
Safety management for lung ventilator
ICS 11.020
C 05
WS
中 华 人 民 共 和 国 卫 生 行 业 标 准
呼吸机安全管理
2019-10-19发布
2020- 05-01实施
中华人民共和国国家卫生健康委员会发布
目次
前言...Ⅱ
1 范围...1
2 规范性引用文件...1
3 术语和定义...1
4 基本要求...2
4.1 管理组织...2
4.2 管理职责...2
4.3 管理制度...2
4.4 档案管理...3
4.5 使用要求...3
5 安全检查...3
6 使用前安全确认...4
7 安全性能状态标识...5
8 日常维护保养...5
9 维修...5
10 清洗和消毒...5
附录 A(资料性附录) 呼吸治疗记录单...6
附录 B(资料性附录) 呼吸机安全检查测试原始记录单...8
附录 C(规范性附录) 呼吸机安全与性能状态标识...10
参考文献...12
前 言
本标准按照 GB/T 1.1-2009给出的规则起草.,
本标准起草单位: 中国人民解放军总医院, 中国医学装备协会, 中国人民解放军联勤保障部队药品
仪器监督检验总站, 中国人民解放军总医院第七医学中心, 联勤保障部队 920医院, 北京朝阳医院.
本标准主要起草人: 吴昊, 曹德森, 严勇, 高岩, 周娟, 孙志辉, 刘文, 王振洲, 李新胜, 刘晓征,
解立新, 马迎民, 佘丹阳, 刘辉.
呼吸机安全管理
1 范围
本标准规定了医疗机构临床治疗使用的呼吸机在临床使用前及使用期间的安全管理要求, 包括操作
人员, 性能检测, 临床使用, 应急调配, 维护保养等的管理和技术要求.
本标准适用于各医疗机构临床治疗使用的呼吸机的安全管理.
本标准不适用于高频喷射呼吸机, 高频振荡呼吸机和仅用作增加患者通气量的设备.
2 规范性引用文件
下列文件对于本文件的应用是必不可少的.凡是注日期的引用文件, 仅注日期的版本适用于本文件.
凡是不注日期的引用文件, 其最新版本(包括所有的修改单)适用于本文件.
GB 8982 医用及航空呼吸用氧
GB 15982 医院消毒卫生标准
JJF 1234 呼吸机校准规范
WS 392 呼吸机临床应用
3 术语和定义
GB 8982, JJF 1234和WS 392界定的以及下列术语和定义适用于本文件.
3.1
呼吸机 lung ventilator
抢救或治疗呼吸功能不全或呼吸衰竭病人, 以增加或供给病人通气, 及(或)传输气雾剂为基础而
设计的生命支持的一种机械通气设备.
3.2
呼吸机安全管理 safety management for lung ventilator
以保证病人安全为目的, 以确保医疗机构所使用的治疗呼吸机达到一定质量水平为目标, 运用管理
和医学工程技术手段对影响治疗呼吸机使用安全的因素, 环节, 流程进行的系统化工作.
3.3
标准操作程序 standard operating procedure
为有效完成某项工作所规定的操作程序.
3.4
操作人员 operator
医疗机构直接使用呼吸机的医学技术人员.
4 基本要求
4.1 管理组织
由医疗机构主管领导, 医疗业务管理部门, 医疗器械管理部门及呼吸机使用部门共同组成呼吸机安全管理组织.
4.2 管理职责
4.2.1 医疗机构主管领导应履行下列职责:
a) 全面负责呼吸机临床使用的安全管理工作;
b) 负责协调, 配置呼吸机安全管理所需要的医疗器械管理人员, 医学工程技术人员与相关检测设
备, 满足 WS 392 规定的呼吸机使用单位的基本要求.
4.2.2 医疗业务管理部门应履行下列职责:
a) 对呼吸机安全控制中的关键环节, 关键活动进行协调和管理;
b) 组织制定呼吸机安全控制计划和管理制度并监督执行;
c) 制定应急预案, 并定期实施演练;
d) 组织安全管理制度落实情况的检查, 抽查, 协调涉及呼吸机安全问题的事宜.
4.2.3 医疗器械管理部门应履行下列职责:
b) 保证呼吸机使用的配套设施, 环境条件等应合制造厂家产品说明书要求;
c) 制定安全操作规程(岗位作业书), 定期对呼吸机使用操作人员进行基础知识和按型号培训操
作人员的技能;
d) 收集安全管理信息, 不良事件, 进行年度安全控制评价, 向医疗机构安全管理组织提交评价报告并提出改进意见;
e) 负责建立呼吸机台账和安全控制工作的档案.
4.2.4 呼吸机使用部门应履行下列职责:
a) 组织本部门人员学习与落实呼吸机安全管理制度;
b) 组织操作人员接受操作规程的培训, 经考核合格方可操作, 保证标准操作程序的施行;
c) 对呼吸机进行日常维护保养;
4.3 管理制度
4.3.1 应包括应急预案制度, 人员培训考核制度, 使用操作管理制度和档案管理制度.
4.3.2 应急预案制度应包括下列内容:
a) 应建立应急调配程序, 包括呼吸机不能满足临床使用时, 启动该程序的授权人;
b) 应配置无创呼吸机或简易呼吸器, 确保紧急情况时临床可以获得治疗呼吸机的生命支持;
c) 当发生呼吸机无法正常使用时, 使用人员将故障呼吸机从诊疗区域撤离, 粘贴“临时故障”标识,
并及时向医疗器械管理部门报修的程序.
4.3.3 人员培训考核制度应包括下列内容:
a) 应符合 WS 392 的规定;
4.3.4 使用操作管理制度应包括下列内容:
a) 应依据呼吸机不同型号制定相应的操作流程, 保证可行性;
b) 操作人员应遵照 WS 392 要求的使用流程和监测指标;
c) 建立使用操作交接班制度, 对患者诊断, 基本情况及其变化, 呼吸支持治疗情况及其疗效,
注意事项等进行交接;
d) 应填写呼吸治疗记录和使用运行记录.
4.4 档案管理
4.4.1 管理性档案应包括下列内容:
a) 使用过程记录;
c) 清洗和消毒记录;
d) 应急调配记录;
e) 其他管理记录.
4.4.2 技术性档案应包括下列内容:
a) 呼吸机使用手册;
b) 呼吸机维修手册;
c) 出厂测试报告或合格证;
d) 各种检测记录.
4.4.3 应由医疗器械管理部门设专人保管或医疗机构档案管理部门统一管理档案.
4.5 使用要求
4.5.1 呼吸机不应通过电源转换器(接线板)连接电源, 应使用三相插头直接与电源连接,
且应确保电源插头在操作人员视野范围内.
4.5.2 呼吸机氧气输入气源应符合 GB 8982的要求.
4.5.3 氧气和压缩空气压力应在 0.25 MPa~0.65 MPa范围内.
4.5.4 临床使用呼吸机应进行呼吸治疗记录, 呼吸治疗记录内容参见附录 A.
5 安全检查
5.1 检查项目
5.1.1 外观检查应包括下列项目:
b) 呼吸机面板上的控制旋钮档位正确, 步跳清晰, 旋转平滑;
c) 呼吸机外置回路标识及标记清楚;
d) 使用说明书及随机的附件齐全.
5.1.2 通用报警检查应包括下列项目:
a) 防误操作电源开关;
b) 静音功能;
c) 静音时限;
d) 报警设置;
e) 断电报警;
5.1.3 危险输出检查应包括下列项目:
a) 空气, 氧气混合系统一路气体缺失或供气压力不足;
b) 误调节的预防措施失灵;
c) 病人回路过压保护装置失效.
5.1.4 通气参数报警功能检查应包括下列项目:
a) 分钟通气量报警;
b) 气道压力报警;
c) 氧浓度报警;
d) 通气频率报警;
f) 通气窒息报警.
5.1.5 通用报警检查测试方法, 危险输出检查测试方法和通气参数报警功能检查测试方法应遵照 JJF
1234的规定.
5.2 通气性能检测
5.2.1 通气性能检测应包括下列项目:
a) 潮气量;
b) 通气频率;
c) 吸气压力水平;
d) 呼气末正压;
f) 气体温度.
5.2.2 通气性能检测方法应符合 JJF 1234的规定.
5.2.3 5.2.1 a)~f) 的各项参数应符合 JJF 1234 的要求.
5.2.4 通气性能检测应由医疗机构具备相应能力的医疗器械管理部门技术人员或委托有能力的维修服务机构进行.
5.2.5 对新购置的和维修后的呼吸机应进行检测.检测合格后方可交付临床使用.
5.2.6 临床在用的呼吸机应进行周期性检测, 每个周期时间≤1年.
5.2.7 当对呼吸机性能参数值发生争议时, 应由法定计量技术机构进行仲裁检测.
5.2.8 5.2.5~5.2.7所进行的各种检测应详细记录, 记录项目和内容参见附录 B.检查测试原始记录应归档保存.
6 使用前安全确认
连接, 呼吸管路和湿化罐连接完成后, 按照 5.1 的要求对呼吸机安全性能进行检查, 并进行详细记录.
6.2 呼吸机性能应达到下列状态:
a) 各个配件无缺损, 处于备用状态;
b) 报警系统工作正常;
c) 吸气端或呼气端安装过滤器;
d) 将呼吸机设定为辅助/控制(A/C)模式下定容通气, 设置基本参数后连接模拟肺, 呼吸机监测
呼出潮气量与设定的潮气量之间的差值范围≤10%;
e) 设置氧浓度分别为 21%和 100%, 氧电池检测氧浓度数值与设定值差值≤5%.
7 安全性能状态标识
7.2 安全性能状态标识分为“合格证”, “停用证”和“临时故障证”三种.合格标识为绿色, 停用
标识为红色, 临时故障标识为黄色.
7.3 安全性能标志的式样见附录 C.
7.4 在进行 5.2.5~5.2.7的检测后, 应由医疗器械技术检测人员根据检测结果粘贴性能状态标识.
检测合格的粘贴“合格”标识, 不合格的粘贴“停用”标识.
7.5 置于病区或其他临床诊疗环境的呼吸机因故障或其他原因不能正常使用时, 应由呼吸机使用人员
粘贴“临时故障”标识, 并报医疗器械管理部门检修.
8 日常维护保养
8.1 应根据呼吸机使用频度, 使用时间等因素制定呼吸机维护保养计划, 每年维修保养次数≥2次.
生产厂家要求和使用实际情况进行维护保养.
8.3 根据使用情况定期更换易耗部件, 保证易损部件性能状态完好.
8.4 应详细记录维护保养的日期, 人员, 具体内容及维保后性能状态, 维护保养记录应归档保存.
9 维修
9.1 医疗机构医疗器械管理部门可自行维修呼吸机, 也可委托有条件和能力的维修服务机构进行.
9.2 应详细记录维修日期, 维修人员和维修内容, 包括检测项目与结果, 配件和易耗部件维修和更换情况.
9.3 维修后应按照 JJF 1234的规定进行呼吸机的安全检查与检测.
10 清洗和消毒
10.1 呼吸机的消毒管理, 消毒方法的选择原则应符合 GB 15982和 WS 392的规定.

WS/T 655-2019
HEALTH INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.020
C 05
Safety Management for Lung Ventilator
呼吸机安全管理
ISSUED ON: OCTOBER 19, 2019
IMPLEMENTED ON: MAY 01, 2020
Issued by: National Health Commission of PRC
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Basic Requirements ... 5
4.1 Management organization ... 5
4.2 Management responsibilities ... 5
4.3 Management system ... 6
4.4 File management ... 7
4.5 Requirements for use ... 8
5 Safety Inspection ... 8
6 Safety Confirmation before Use ... 10
7 Label of Safety Performance Status ... 11
8 Routine Maintenance ... 11
9 Repair ... 11
10 Cleaning and Disinfection ... 12
Appendix A (Informative) Expiratory Treatment Record List ... 13
Appendix B (Informative) Original Record List of Safety Inspection and Test of
Ventilator ... 15
Appendix C (Normative) Ventilator Safety and Performance Status Labels .. 17
Bibliography ... 20
Safety Management for Lung Ventilator
1 Scope
This Standard specifies the safety management requirements for lung ventilator used
in clinical treatment by medical institutions before and during clinical use; including
management and technical requirements for operators, performance testing, clinical
use, emergency deployment, and maintenance, etc.
This Standard is applicable to the safety management of lung ventilator used in clinical
treatment by various medical institutions.
This Standard is not applicable to high-frequency jet ventilator, high-frequency
oscillatory ventilator and equipment used only to increase patient ventilation.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB 8982 Oxygen Supplies for Medicine and Aircraft Breathing
GB 15982 Hygienic Standard for Disinfection in Hospitals
JJF 1234 Calibration Specification for Ventilators
WS 392 Clinical Application of Ventilator
3 Terms and Definitions
For the purpose of this document, the terms and definitions given in GB 8982, JJF
1234 and WS 392 and the following apply.
3.1 Lung ventilator
A life-supporting mechanical ventilation device designed to rescue or treat patients with
respiratory insufficiency or respiratory failure, based on increased or supplied patient
ventilation and/or delivery of aerosol.
ventilator.
4.2.3 The medical device management department shall perform the following
duties:
a) Organize the safety testing, maintenance and repair of ventilator; and deal with
the technical problems related to safety;
b) Ensure that the supporting facilities and environmental conditions used by the
ventilator shall meet the requirements of the manufacturer's instruction manual;
c) Formulate safe operation regulations (post workbooks); and regularly carry out
basic knowledge training and training skills of the operators using the ventilator
as per the models;
d) Collect safety management information and adverse events, conduct an annual
safety control evaluation. Submit an evaluation report to the medical institution's
e) Responsible for the establishment of ventilator accounts and safety control files.
4.2.4 The ventilator use department shall perform the following duties:
a) Organize the staff of this department to learn and implement the safety
management system of ventilator;
b) Organize the operators to receive training on operating procedures; operate only
after passing the assessment; and ensure the implementation of standard
operating procedures;
c) Daily maintenance of the ventilator;
d) Once the ventilator malfunction is found, make sure to implement the emergency
4.3 Management system
4.3.1 It shall include the emergency plan system, personnel training assessment
system, use operation management system and file management system.
4.3.2 The emergency plan system shall include the following:
a) It shall establish emergency deployment procedure, including the authorized
person who initiates the procedure when the ventilator cannot meet clinical use;
b) it shall configure non-invasive ventilator or simple ventilator to ensure that the life
support of the therapeutic ventilator can be obtained clinically in an emergency;
d) Various test records.
custody of the files; or the file management department of the medical institution shall
manage the files in a unified manner.
4.4.4 All files shall be kept for 5 years after the ventilator is terminated.
4.5 Requirements for use
4.5.1 The ventilator shall not be connected to the power supply through the power
converter (terminal block); it shall be directly connected to the power supply by a three-
phase plug; and ensure that the power plug is within the operator's field of vision.
4.5.2 The source of oxygen input to the ventilator shall meet the requirements of GB
8982.
0.65 MPa.
4.5.4 The ventilator for clinical use shall be recorded for respiratory therapy. For the
content of respiratory therapy, please refer to Appendix A.
5 Safety Inspection
5.1 Inspection items
5.1.1 The appearance items shall include the following items:
a) The ventilator shall be marked with manufacturer, model, exit-factory date and
number, power supply rated voltage, frequency, gas source name and pressure
range;
and smooth rotation;
c) The external circuit of the ventilator is clearly identified and marked;
d) The instruction manual and accompanied accessories are complete.
5.1.2 The general alarm inspection should include the following items:
a) Anti-mis-operation power switch;
b) Mute function;
f) Gas temperature.
5.2.2 Ventilation performance testing method shall comply with the provisions of JJF
1234.
5.2.4 Ventilation performance test shall be performed by technicians of medical device
management departments with corresponding capabilities of medical institutions or
entrusted by competent maintenance service agencies.
5.2.5 The newly purchased and repaired ventilator shall be tested. Only after passing
the test can it be delivered for clinical use.
5.2.6 The ventilator in clinical use shall be periodically tested, each cycle time ≤ 1 year.
5.2.7 When there is a dispute over the performance parameter value of the ventilator,
the legal measurement technical agency shall conduct arbitration test.
5.2.8 The various tests conducted in 5.2.5 ~ 5.2.7 shall be recorded in detail. For the
testing shall be archived and kept.
6 Safety Confirmation before Use
6.1 Before each use on a patient, the clinical user or the technical staff of the medical
device management department shall, after the connection of the air source, power
supply, breathing tube and humidification tank of the ventilator, inspect the safety of
the ventilator according to the requirements in 5.1 and make detailed records.
6.2 The performance of the ventilator shall reach the following state:
a) All accessories are intact and in standby state;
b) The alarm system works normally;
d) Set the ventilator to constant volume ventilation in assist/control (A/C) mode;
connect the simulated lung after setting the basic parameters; and the difference
range between the ventilator monitoring exhaled tidal volume and the set tidal
volume shall be ≤10%;
e) Set the oxygen concentration to 21% ~ 100%, respectively; and the difference
between the value of the oxygen concentration detected by the oxygen battery
and the set value shall be ≤5%.
7 Label of Safety Performance Status
7.1 The ventilator shall be used as a medical device for mandatory verification; and
7.2 The safety performance status labels are divided into three types: "Qualification
Certificate", "Deactivation Certificate" and "Temporary Failure Certificate". The
qualified label is green, the deactivation label is red, and the temporary fault label is
yellow.
7.3 The style of the safety performance label is shown in Appendix C.
7.4 After performing the tests from 5.2.5 to 5.2.7, the medical device technical testing
personnel shall paste the performance status label according to the test results. Paste
the "qualified" label for those passing the test; and paste the "deactivated" label for
unqualified.
environment, or cannot be used normally due to failure or other reasons, the person
who uses the ventilator shall paste the "temporary failure" label and report it to the
medical device management department for repair.
8 Routine Maintenance
8.1 The maintenance plan of the ventilator shall be formulated according to factors
such as the frequency of use of the ventilator and the time of use, and the number of
repairs and maintenance shall be ≥ 2 times per year.
8.2 The internal or external air compressors, oxygen sensors, leather pads, filters or
filter nets and other vulnerable and consumable parts shall be maintained according
8.3 Replace consumable parts regularly according to usage conditions to ensure that
the performance status of vulnerable parts is in good condition.
8.4 The maintenance date, personnel, specific content and performance status after
maintenance shall be recorded in detail, and the maintenance records shall be
archived and kept.
9 Repair
9.1 The medical device management department of a medical institution may repair
the ventilator by itself, or it may entrust a qualified and capable maintenance service
   
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