Juridical Review of Medical Devices in Legal 在 RSPAD Gatot Soebroto 对医疗器械的法律

Regulation, Hospital Accreditation, and ISO 监管、医院评审和 ISO 管理体系进行司法审查

Management System at RSPAD Gatot Soebroto

Rineke Sara1, Ramlan2 Rineke Sara 1 , Ramlan 2

rineke_sara@borobudur.ac.id1, syukriramlan045@gmail.com2 rineke_sara@borobudur.ac.id 1 , syukriramlan045@gmail.com 2

Universitas Borobudur1, 2 婆罗浮屠大学 1, 2

Abstract. The use of medical devices according to standards will improve the quality of 摘要按照标准使用医疗设备将提高社区医疗服务的质量。优质医疗服务对提高社区
health services for the community. Quality health services have implications for improving 生活质量具有重要意义。本研究从法律法规、医院认证和使用国内内容水平（TKD
the quality of life of the community. This study analyzes the feasibility of using medical N）等方面分析了使用医疗设备的可行性。本研究采用定性方法，以案例研究法作
devices in terms of legal regulations, hospital accreditation and the use of the Domestic 为探究策略。通过深入访谈和观察收集原始数据。通过文件研究收集了二手数据，
Content Level (TKDN). This research uses a qualitative approach with the case study 并对定性数据结果进行了深入分析。研究结果表明，在 RSPAD Gatot Subroto 医院
method as a strategy of inquiry. Primary data collection was conducted by in-depth ，按照法律规定使用医疗器械、医院认证以及使用和关注带有 TKDN 的医疗器械对
interviews and observations. While secondary data were collected through document 患者的优质医疗服务具有影响。
studies and analyzed with qualitative data findings intensively. The results of this study
show that the use of medical devices in accordance with legal regulations, hospital
accreditation and using and paying attention to medical devices with TKDN have
implications for quality health services among patients at RSPAD Gatot Subroto hospital.

Keywords: RSPAD Gatot Soebroto, Juridical Review, Medical Devices. 关键词RSPAD Gatot Soebroto、司法审查、医疗器械。

1 Introduction 1 引言

The Dutch colonial government established the Groot Militair Hospitaal Weltevreden 荷兰殖民政府于 1936 年 10 月建立了 Groot Militair Hospitaal Weltevreden，它是 RSP
in October 1936, which served as a precursor to the RSPAD Gatot Soebroto Army Central AD Gatot Soebroto 陆军中心医院的前身。在不断发展的同时，加托特-索埃布罗托医疗
Hospital. Alongside its ongoing presence, Gatot Soebroto Medical clinic has turned into a kind 诊所已成为一种行政诊所，是整个印尼军队和军队中最值得一提的参考，同样也是全体
An administration clinic and is the most noteworthy reference in the positions of the TNI overall 人民的福利管理机构。RSPAD Gatot Soebroto是军事大本营（Mabesad）的一个执行部
and the Military specifically, which is likewise a wellbeing administration for the overall 门，直接隶属于印尼武装部队参谋长（Kasad），其主要任务是为印尼军队提供最高级
population. RSPAD Gatot Soebroto is a carrying out component at the Military Base camp 别的医疗服务，帮助印尼武装部队履行义务。Gatot Soebroto 急诊室不仅是印尼军队最
(Mabesad) level which is straightforwardly under the Head of Staff of the Indonesian Armed 高级别的参考诊所，也是真正的官方参考诊所。Gatot Soebroto 诊所不仅获得了广泛和
force (Kasad) which has the principal assignment of giving the most elevated wellbeing 普遍的认证，还被指定为 PKBLU 急诊诊所，其主要任务是为贵宾、战士和政府工作人员
administrations in the positions of the TNI to help the obligations of the Indonesian Armed 及其家属提供全面的医疗服务，并在相关法规和指导方针的指导下，进一步提高管理质
force. Aside from being the most elevated reference medical clinic in the positions of the TNI, 量和患者安全。
Gatot Soebroto Emergency clinic is additionally the really official reference clinic. Gatot
Soebroto Clinic, as well as being broadly and universally certify, is likewise assigned as a PK-
BLU emergency clinic which has the primary undertaking of giving total wellbeing
administrations to VVIPs, warriors and government workers and their families and is directed
by pertinent regulations and guidelines to further develop administration quality and patient
security.
The vision of Gatot Soebroto Clinic is to turn into an official standard emergency 加托特-索博罗托（Gatot Soebroto）诊所的愿景是成为一家官方标准急诊诊所，成为
clinic, which is the pride of troopers, the TNI family and the local area. In the interim, the 部队官兵、印尼军大家庭和当地的骄傲。在此期间

MIC 2023, October 28, Jakarta, Indonesia MIC 2023，10 月 28 日，印度尼西亚雅加

Copyright © 2023 EAI 达 Copyright © 2023 EAI DOI 10.4108/ea
DOI 10.4108/eai.28-10-2023.2341747 i.28-10-2023.2341747
missions of RSPAD Gatot Soebroto, among others: ( a) Putting together the best medical care RSPAD Gatot Soebroto 的任务包括(a) 为总统、副总统及其家人，以及前总统、副总统
for the President, Vice President, and their families, as well as former presidents and vice 及其家人和国宾提供最好的医疗服务；(b) 为战士、印尼军队远亲、高级国家机关和地
presidents and their families and state visitors; ( b) Coordinating the most noteworthy whole 方协调最值得关注的整体和参考急诊管理；(c) 通过全球标准的医疗诊所管理，建立公共
and reference emergency clinic administrations for Warriors, TNI More distant family, High 健康框架；(d) 提供精英式的援助；(e) 通过指导和准备，提高健康工作者的能力，并促
State Authorities and the Local area; ( c) Putting together the Public Wellbeing Framework 进基于探索的管理。
through worldwide standard medical clinic administrations; ( d) Offering elite phenomenal
types of assistance; also (e) Work on the capacity of wellbeing laborers through instruction and
preparing and foster prevalent exploration based administrations.
Gatot Soebroto Hospital, which was built on 12.5 hectares of land and has a building Gatot Soebroto 医院占地 12.5 公顷，建筑面积 115 010 平方米，拥有充足的设施和基
area of 115,010 m2, has adequate facilities and infrastructure to accomplish the aforementioned 础设施来实现上述愿景和使命。印度尼西亚共和国 2009 年第 36 号《福利法》第 1 条
vision and mission. One of these is the installation of a material warehouse to store health 第 3 款规定，福利用品是完成福利工作所需的材料和设备。安康工作本身是指公共当局
supplies in accordance with Law No. 36 of 2009 concerning Wellbeing.[1] In article 1 section 或当地以协调、配合和合理的方式开展的任何工作以及一系列工作，以保持和提高总体
3 of Law of the Republic of Indonesia Number 36 of 2009 concerning Wellbeing, it is expressed 安康水平，如疾病预防、安康改善、疾病治疗和安康恢复。因此，Gatot Soebroto 医院
that wellbeing supplies are materials and gear expected to complete wellbeing endeavors. 总是提供医疗用品，这些用品通常存放在物资仓库。加托特-索埃布罗托急诊室的物资
Wellbeing endeavors themselves are any exercises and additionally series of exercises did in a 仓库由一个整体物资配送中心和一个健康物资仓库组成。
coordinated, coordinated and reasonable way to keep up with and work on the level of general
wellbeing as illness avoidance, wellbeing improvement, sickness therapy, and wellbeing
recuperation by the public authority or potentially the local area. Because of this, Gatot Soebroto
Hospital always provides medical supplies that are typically housed in material warehouse
installations. The establishment of the material stockroom at Gatot Soebroto Emergency clinic
comprises of an overall material distribution center and a wellbeing material stockroom.
Related to the above, Gatot Soebroto Hospital has a commitment to providing health 与此相关的是，加托特-索埃布罗托医院致力于提供医疗服务，尤其是在医疗器械方面
services, especially in terms of medical devices. In article 1 section 3 of Law of the Republic of 。印度尼西亚共和国 2009 年第 36 号《保健法》第 1 条第 3 款规定，保健用品是指完
Indonesia Number 36 of 2009 concerning Wellbeing, it is expressed that wellbeing supplies are 成保健工作所需的材料和设备。福祉工作本身是指公共机构或潜在的地方以协调、配合
materials and gear expected to complete wellbeing endeavors. Wellbeing endeavors themselves 和合理的方式开展的任何工作以及一系列工作，以保持和提高总体福祉水平，如疾病预
are any exercises and additionally series of exercises did in a coordinated, coordinated and 防、福祉改善、疾病治疗和福祉恢复、工具和/或植入物、体外试剂和校准器、软件、
reasonable way to keep up with and work on the level of general wellbeing as illness avoidance, 材料或单独或组合使用的材料、用于预防、分析、修复和缓解疾病，治疗死亡人员，重
wellbeing improvement, sickness therapy, and wellbeing recuperation by the public authority 建人们的健康，以及组织和进一步发展人体能力、阻塞准备、临床小工具的消毒和人体
or potentially the local area, tools, and/or implants, in vitro reagents and calibrators, software, 实例的体外测试，并可能包含不通过药理学、免疫学或新陈代谢周期在人体内完成基本
materials or materials used single or in combination, to forestall, analyze, fix, and ease illnesses, 活动以帮助实现理想能力/执行的药物。
treat wiped out individuals, reestablishing wellbeing in people, and additionally organizing and
further developing body capabilities, obstructing preparation, sanitization of clinical gadgets,
and in vitro testing of examples from the human body, and may contain drugs that don't
accomplish essential activity in the human body through pharmacological, immunological or
metabolic cycles to help the ideal capability/execution.
In addition, there must be a significant amount of domestic content in medical devices 此外，医疗器械和体外诊断医疗器械中必须有大量的国产成分--国产成分水平，在本文
and in vitro diagnostic medical devices—the Domestic Component Level, also referred to as 中也称为 TKDN。与 TKDN 相关的是 2022 年第 31 号《关于确定临床器械和体外示范临
TKDN in this document. Connected with TKDN, this is managed in the Guideline of the 床器械国产部件价值水平的安排和策略的行业指导原则》。该TKDN计划有助于提高临
Clergyman of Industry Number 31 of 2022 concerning Arrangements and Strategies for 床小工具行业和国产体外分析临床小工具行业的水平，进一步发展一般安康保障。
Ascertaining the Worth of Homegrown Part Levels of Clinical Gadgets and In Vitro
Demonstrative Clinical Gadgets. This TKDN plans to help the improvement of the clinical
gadget industry and the homegrown in vitro analytic clinical gadget industry in further
developing general wellbeing security.
Based on the above, the author intends to conduct a juridical review of the feasibility 基于以上所述，作者打算对加托特-索布洛托医院的医疗器械在法律法规、医院认证和 I
of medical devices in legal regulations, hospital accreditation, and ISO management systems at SO 管理体系中的可行性进行司法审查。在本文中，司法审查可解释为根据法律法规或
Gatot Soebroto Hospital. In this paper, juridical review can be interpreted as a rigorous 以法律法规为基础，系统、客观地对某一事物进行的严格审查活动、数据收集或调查。
examination activity, data collection or investigation carried out systematically and objectively
on something according to or based on laws and regulations.[2] The Law of the Republic of
Indonesia Number 36 of 2009 about Wellbeing and Guideline of the Clergyman of Strength of [3]除法律方面的审查外，笔者还根据印度尼西亚共和国实力牧师关于急诊室许可证准则
the Republic of Indonesia Number 54 of 2015 concerning Testing and Adjustment of Clinical 的第Hk.01.07/Menkes/1128/2022号宣言和关于医疗设备质量管理体系的ISO 13485进
Gadgets are connected with the subject of writing in this legal audit.[3] In addition to the review 行医院认证方面的审查。
in legal aspects, the author also conducts a review in the aspect of hospital accreditation as per
the Declaration of the Pastor of Strength of the Republic of Indonesia Number
Hk.01.07/Menkes/1128/2022 concerning Emergency clinic License Guidelines and ISO 13485
concerning medical equipment quality management systems.[4]

2 Method 2 方法

The sort of lawful examination utilized is regulating legitimate exploration. Regulating 使用的合法检查类型是规范性合法检查。5] 在这种合法性审查中，法律通常被概念化为
legitimate examination is lawful exploration led by inspecting optional writing or 法律和准则（书本中的规定）中所写的内容，或者规定被概念化为决定或标准，这些决
information.[5] In this kind of legitimate examination frequently the law is conceptualized as 定或标准是人类行为方式的基准，被认为是正确的。此外，本研究还涉及一种法律方法
what is written parents in law and guidelines (regulation in book) or regulation is conceptualized 论，在本研究中，该方法论围绕印度尼西亚共和国 2009 年第 36 号《繁荣法》和印度
as decides or standards that are a benchmark for human way of behaving that is viewed as 尼西亚共和国 2015 年第 54 号《充足教士规则》（关于临床器械的测试和安排）展开
proper. What's more, this review involves a legal methodology which in this review centers 。尽管从合法的角度进行了调查，但创建者同样根据《印度尼西亚共和国卫生部长关于
around Law of the Republic of Indonesia Number 36 of 2009 concerning Prosperity, and Rule 医院认证标准的第Hk.01.07/Menkes/1128/2022号声明》和关于医疗设备质量管理系统
of the Cleric of Sufficiency of the Republic of Indonesia Number 54 of 2015 concerning Testing 的ISO 13485标准，指导对医疗诊所认证部分进行审计。
and Arrangement of Clinical Contraptions. Notwithstanding the survey in legitimate
perspectives, the creator likewise directs an audit in the part of medical clinic certification as
per the Declaration of the Clergyman of Soundness of the Republic of Indonesia Number
Hk.01.07/Menkes/1128/2022 concerning Hospital Accreditation Standards and ISO 13485
concerning medical equipment quality management systems.
In view of the kind of lawful exploration utilized is regularizing legitimate 鉴于合法性审查所使用的法律探索类型，本研究中所指的探索信息为辅助信息，具体包
examination, the exploration information that is referred to in this study is Auxiliary 括基本法律材料和可选法律材料。[6] 基本法律材料是指具有权威性的确定性法律材料
Information, to be specific as Essential Lawful Material and Optional Lawful Material.[6] ，其中包括法规、官方记录或确定法规和法官选择的会议记录。[7] 而辅助法律材料则
Essential legitimate material is lawful material that is definitive, which has authority, which 从合法和不合法的书面情感、与从发言人处获得的数据有关的研究成果中获得。使用可
incorporates regulation, official records or minutes in settling on regulation and judges' 选的合法材料是为了给专家们提供一种 "提示"，告诉他们考试的方向。然后，在这篇文
choices.[7] While auxiliary legitimate materials are obtained from lawful and non-lawful 章中，对于信息审查策略，从严密的视角应用了顽固的法规或合法科学的五项任务，重
sentiments from writing, research results connected with data acquired from the speakers. The 点关注确定的法规，特别是法规和准则，其中包括、描绘、系统化、调查、理解和评估
utilization of optional lawful material is to furnish specialists with a sort of "hint" in which 积极的法规和评估，以回答问题[8]。
heading the examination is heading. Then, at that point, for the information examination strategy
in this composing applies five errands of obdurate regulation or legitimate science from a tight
perspective that spotlights on sure regulation, specifically regulations and guidelines which
incorporate, depiction, systematization, investigation, understanding and appraisal of positive
regulation and assessment to answer issues.[8]

3 Results and Discussion 3 结果与讨论

3.1 Implementation of Regulation of the Minister of Health of the Republic of Indonesia 3.1 印度尼西亚共和国卫生部 2015 年第 54 号《医疗器械测试与校准条例》的实施情况
Number 54 of 2015 concerning Testing and Calibration of Medical Devices
Medical device technology currently has excellent capabilities and quality, so 目前，医疗器械技术具有卓越的能力和质量，因此可以利用这些医疗器械检测出各
that various kinds of health problems can be detected using these medical devices. 种健康问题。但是无论医疗设备的质量有多好，并不意味着该工具总能以最佳状态
But. No matter how good the quality of the medical device is, it does not mean that 运行。有必要对医疗设备进行维护、测试和校准，以提高这些医疗设备的准确性。
the tool always works optimally. There is a need for maintenance, testing and
calibration of medical devices to improve the accuracy of these medical devices.
 In view of Regulation No. 36 of 2009 concerning Wellbeing, it gives everybody the 鉴于 2009 年关于福利的第 36 号条例，人人都可以选择获得受保护、优质和合理
option to get protected, quality, and reasonable wellbeing administrations. To improve the 的福利管理。为了提高医疗服务的质量和安全性，有必要提供高质量的医疗器械，
quality and safety of health services, it is necessary to provide quality medical devices, 即保证准确性、精确性和使用安全性的医疗器械。医疗器械必须具备严格的性能，
namely medical devices that are guaranteed accuracy, accuracy and safety of their use. 包括准确性、灵敏性、再现性和安全性。因此，在使用过程中，它将始终处于随时
Medical devices must have strict performance, including accuracy, sensitivity, 可用的状态，并具备使用医疗设备的技术标准。
reproducibility and safety aspects. So that in its use it will always be ready to use and have
technical standards for the use of medical equipment.
The gamble of clinical gadgets that are not tried or aligned, has an inappropriate 使用未经试验或未对准的临床小工具进行赌博，会产生不恰当的结果，导致指示性
result that will cause less exact indicative outcomes and helpful portions. Essentially, 结果和有用部分不够准确。从根本上说，未在特定时间范围内使用和从未进行过维
clinical gadgets that are not utilized for a specific timeframe and have never been done 护的临床设备会导致可靠性降低、健康得不到保证以及硬件状态得不到控制。
upkeep cause a reduction in the degree of dependability, wellbeing isn't ensured and the
state of the hardware isn't controlled.
In connection with global demands in the quality of health services, the existence of 根据全球对医疗服务质量的要求和 2009 年第 8 号《消费者保护法》，[9] 医疗服
Law No. 8 of 2009 concerning Consumer Protection,[9] medical devices used in Health 务设施中使用的医疗设备必须根据医疗设备的类型定期进行测试和/或校准，以免
Service Facilities so as not to risk harming recipients of health services must be tested and 对医疗服务对象造成伤害。
/ or calibrated periodically according to the type of medical device.
As per Unofficial law Number 60 of 2008 concerning the Public authority Interior 根据 2008 年第 60 号关于公共机构内部控制框架（SPIP）的非官方法律，第 11 条
Control Framework (SPIP) article 11 has given a firm command that in an administration 明确规定，在管理框架中需要有一个强大的政府内部监督机制，而印度尼西亚共和
framework there is a requirement for a powerful government interior oversight contraption 国 2015 年第 54 号关于临床小工具测试和校准的《健全牧师准则》第 4 条第 1 款
and Guideline of the Clergyman of Soundness of the Republic of Indonesia Number 54 of 、第 6 条第（1）、（2）、（3）款和第 9 条第（1）、（2）款则表示
2015 concerning Testing and Alignment of Clinical Gadgets article 4 section (1), article 6
passage (1), (2), (3) and article 9 sections (1), (2) have expressed that:
• Article 4 paragraph (1): - 第 4 条第(1)款
" Each Clinical Gadget utilized in Wellbeing Administration Offices and other "安康管理办公室和其他安康办公室使用的每个临床小工具应由安康办公室测试
Wellbeing Offices should be tried and additionally adjusted occasionally by the 中心或安康办公室测试机构偶尔试用和调整"。
Wellbeing Office Testing Center or Wellbeing Office Testing Establishment."

In the article and paragraph above, every health service facility and other health 在上述条款和段落中，每个医疗服务机构和其他医疗机构（本例中为 Gatot Sub
facilities in this case Gatot Subroto Hospital must test and / or calibrate every medical roto 医院）都必须对用于提供医疗服务的每个医疗设备进行测试和/或校准。在
device that will be used in providing health services. In this context, RSPAD Gatot 这种情况下，Gatot Subroto 医院在使用医疗器械之前，必须先向医疗器械供应
Subroto before using medical devices first asks for a license for the test and calibration 商申请医疗器械测试和校准许可证。
of medical devices from medical device providers.

• Article 6 paragraph (1): - 第 6 条第(1)款规定

" Testing of Medical Devices in Health Care Facilities and other Health Facilities "医疗机构和其他卫生机构对医疗器械的测试包括功能测试、安全测试和性能测
includes function tests, safety tests, and performance tests." 试"。

In the article and paragraph above, medical devices used by Gatot Subroto Hospital 在上述条款和段落中，Gatot Subroto 医院使用的医疗器械以功能测试、安全测
carry out tests and / or calibrations of each medical device in the form of function tests, 试和性能测试的形式对每个医疗器械进行测试和/或校准。
safety tests, and performance tests.

• Article 9 paragraph (1): - 第 9 条第(1)款

" Medical Devices that have met the standards based on the results of Testing and/or "根据测试和/或校准结果符合标准的医疗器械必须获得适合使用证书和标签"。
Calibration, must be given a Certificate and Label of Fit for Use."

In the article and paragraph above, Gatot Subroto Hospital has stored certificates and 在上述条款和段落中，Gatot Subroto 医院保存了所使用医疗器械的合格证书和
labels of the eligibility of the medical devices used. However, there are still medical 标签。然而，仍有一些医疗器械没有合格证书和标签，却被贴上了 "适合使用 "
devices that do not have certificates and labels of eligibility, but are given a label of 的标签。
 information of unfit for use as stated in article 9 paragraph 2, " Medical Devices that 第 9 条第 2 款规定，"根据检测和/或校准结果不符合标准的医疗器械，必须提
do not meet the standards based on the results of Testing and / or Calibration, must be 供不适合使用的信息和标签"。
given information and labels are not fit to use."
3.2 Implementation of Hospital Accreditation 3.2 实施医院评审
A medical clinic is a wellbeing administration organization that gives entire 医疗诊所是一个提供长期、短期和危机管理的整体个人健康管理机构。在提供各类
individual wellbeing administrations that give long term, short term, and crisis 援助时，急诊诊所应注重质量和患者安全。优质健康管理是指具有受保护、理想、
administrations. In offering types of assistance, emergency clinics should focus on quality 富有成效、可行、由患者安排、公平和整合等特性的管理。医院服务质量的实现有
and patient security. Quality wellbeing administrations are administrations that have the 两种途径，即内部质量改进和外部质量改进。
personality of protected, ideal, productive, viable, patient-arranged, fair and incorporated.
Fulfillment of service quality in hospitals is carried out in two ways, namely internal
quality improvement and external quality improvement.
Internal Continuous Quality Improvement, where the hospital makes periodic 内部持续质量改进，即医院定期开展质量改进工作，包括制定、测量、报告和评估
quality improvement efforts, including setting, measuring, reporting and evaluating quality 质量指标，报告患者安全事件。这种内部质量改进是医院确保服务质量的重中之重
indicators and reporting patient safety incidents. This internal quality improvement is the 。外部持续质量改进是医院整体服务质量改进工作的一部分。包括外部质量改进在
most important thing for hospitals to ensure the quality of service. External Continuous 内的一些活动有许可、认证和评审。根据《印度尼西亚共和国实力牧师关于诊所认
Quality Improvement is part of efforts to improve the quality of service in the hospital as 证准则的声明》（编号：Hk.01.07/Menkes/1128/2022），诊所许可证是对诊所管
a whole. Some activities that include external quality improvement are licensing, 理性质的一种认可，在评估之后，诊所必须满足公共机构支持的认证准则。
certification, and accreditation. Clinic license as per the Declaration of the Priest of
Strength of the Republic of Indonesia Number Hk.01.07/Menkes/1128/2022 concerning
Clinic Certification Guidelines is an acknowledgment of the nature of clinic
administrations after an evaluation is made that the clinic has satisfied the certification
guidelines supported by the Public authority.[10]
Related to the components of hospital accreditation, one of them is the quality and 与医院认证相关的内容之一是医院所拥有的医疗设备的质量和品质。换言之，Gato
quality of medical devices owned by hospitals. In other words, Gatot Soebroto Hospital, t Soebroto 医院获得了独立认证评估机构（LIPA），即印尼医疗机构认证机构（LA
which has Plenary accreditation from the Independent Accreditation Assessment Institute FKI）的全面认证，其使用的医疗设备肯定符合标准。
(LIPA), namely the Indonesian Health Facility Accreditation Institute (LAFKI), has
certainly been declared that the medical devices it uses are in accordance with standards.

3.3 ISO Management System Implementation 3.3 ISO 管理体系的实施

ISO certificate is a proof of service in international quality health institutions. So ISO 证书是国际优质医疗机构的服务证明。可以这样理解，ISO 是一个独立机构对
that it can be interpreted, ISO is a recognition from an independent institution for the 医院质量和服务的认可。其中一个 ISO 标准与医疗设备质量管理体系标准有关，即
quality and services produced by hospitals. One of the ISO related to standards on medical ISO 13485。
equipment quality management systems, namely ISO 13485.
This standard gives a structure to associations to create, execute, screen and 该标准为各协会创建、执行、筛选和持续进一步发展临床设备质量管理框架提供了
consistently further develop clinical gadget quality administration frameworks and 一个结构，并符合相关法规和准则以及其他要求。
consistence with relevant regulations and guidelines and different necessities.
The purpose of ISO 13485 is to produce a safe medical device production process ISO 13485 的目的是为客户提供安全的医疗器械生产过程。通过一系列质量标准流
for customers. Through a series of quality standard processes including consistency in 程，包括设计、开发、生产、安装和向直接客户或分销商交付医疗器械的一致性。
design, development, production, installation, and delivery of medical devices to direct 通过 ISO 13485，可以防止医疗器械的泄漏和滥用。获得 ISO 13485 认证意味着医
customers or distributors. Through ISO 13485, prevention of the release of medical 院在医疗设备质量管理系统领域获得了全球认可的证书。这证明医院能够提供安全
devices and their misuse can be applied. Being ISO 13485 certified means that the hospital 、合格的医疗设备，并获得客户的信任。
has received a globally recognized certificate in the field of medical equipment quality
management systems. This proves that the hospital has been able to provide safe and
competent medical devices and achieve customer trust.
 Related to ISO 13485, based on the results of field research conducted by the 关于 ISO 13485，根据笔者进行的实地调查结果，RSPAD Gatot Soebroto 没有实
author, RSPAD Gatot Soebroto has not implemented an ISO 13485 management system 施 ISO 13485 医疗器械质量管理体系。
for quality management of medical devices.

4 Conclusion 4 结论
RSPAD Gatot Soebroto is a type A government hospital that is the highest reference RSPAD Gatot Soebroto 是一家甲级政府医院，是印尼军队（尤其是印尼陆军）的最高
in the ranks of the TNI in general and the Army in particular. It is also a health service for the 参照标准。同时，它也是一所为公众提供医疗服务的医院，并将继续努力提高医疗质量
general public that continues to strive to improve its quality in an effort to provide complete ，为每一位患者提供完善的医疗服务。RSPAD Gatot Soebroto 也是为公众提供医疗服
health services for each patient. RSPAD Gatot Soebroto is also a health service for the general 务的机构。这无疑是其中的一项努力，其次是提高所使用医疗器械的质量。印度尼西亚
public. This effort is certainly one of them followed by quality improvements in the medical 共和国实力牧师 2015 年第 54 号《临床小工具测试和校准指南》第 4 条第 (1) 款、第 6
devices used. Connected with the Guideline of the Pastor of Strength of the Republic of 条第 (1) 款和第 9 条第 (1) 款、第 (2) 款规定，Gatot Soebroto 医院在使用医疗设备之前
Indonesia Number 54 of 2015 concerning Testing and Alignment of Clinical Gadgets article 4 ，应首先向医疗设备提供商申请医疗设备测试和校准许可证。此外，加托特苏布罗托医
passage (1), article 6 section (1), and article 9 passage (1), (2) states that Gatot Soebroto Hospital 院还以功能测试、安全测试和性能测试的形式对每个医疗设备进行测试和/或校准。RSP
before using medical devices first asks for a license for the test and calibration of medical AD Gatot Soebroto 储存了所使用医疗设备的合格证书和标签。但是，仍有一些医疗器
devices from medical device providers. In addition, Gatot Subroto Hospital conducts tests and 械没有合格证书和标签，却被贴上了不适合使用的信息标签。与医院评审的内容有关，
/ or calibrations of each medical device in the form of function tests, safety tests, and 其中之一就是医院所拥有的医疗器械的质量和品质。换句话说，Gatot Soebroto 医院获
performance tests. RSPAD Gatot Soebroto has stored certificates and labels of eligibility for the 得了独立认证评估机构（LIPA），即印尼医疗机构认证机构（LAFKI）的全面认证，它
medical devices used. However, there are still medical devices that do not have certificates and 所使用的医疗器械肯定是符合标准的。关于 ISO 13485，根据笔者的实地调查结果，RS
labels that are fit to use, but are given information labels that are not fit to use. Related to the
PAD Gatot Soebroto 没有实施 ISO 13485 医疗器械质量管理管理体系。
components of hospital accreditation, one of them is the quality and quality of medical devices
owned by hospitals. In other words, Gatot Soebroto Hospital, which has Plenary accreditation
from the Independent Accreditation Assessment Institute (LIPA), namely the Indonesian Health
Facility Accreditation Institute (LAFKI), has certainly been declared that the medical devices it
uses are in accordance with standards. Related to ISO 13485, based on the results of field
research conducted by the author, RSPAD Gatot Soebroto has not implemented an ISO 13485
management system for quality management of medical devices.

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