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Human factors in the design of medical devices – approaches to meeting international standards in the European Union and USA

机译：医疗设备设计中的人为因素–达到欧盟和美国国际标准的方法

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This paper is embargoed until twelve months after publication.

机译：该文件将被禁运至发表后十二个月。

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Privitera, Mary B.; Evans, Mark A.; Southee, Darren J.;
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1. First amendment to the international standard for EMC on medical devices: Amendment 1 to IEC 60601-1-2 is worth a careful reading by anyone involved in the design, manufacturing, and/or testing of electrical medical equipment [J] . DANIEL D. HOOLIHAN Interference Technology: EMC Directory & Design Guide . 2005,第2005期

机译：医疗设备EMC国际标准的首次修订：涉及电气医疗设备设计，制造和/或测试的任何人都应认真阅读IEC 60601-1-2的修订1
2. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) (vol 37, pg 459, 2019) [J] . Journal of hypertension . 2020,第3期

机译：执行和报告验证研究的建议和实践指导根据血压测量装置的常用标准，通过协会进行医疗仪器/欧洲高血压/国际标准化组织（AAMI / ESH / ISO）（AAMI / ESH / ISO）（ Vol 37，PG 459,2019）
3. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) [J] . Stergiou George S., Palatini Paolo, Asmar Roland, Journal of hypertension . 2019,第3期

机译：根据血压测量装置验证的普遍标准，通过协会进行血压测量装置的普遍标准的建议和实践指导，用于医疗仪器/欧洲高血压/国际标准化组织（AAMI / ESH / ISO）
4. MUTUAL ACCEPTANCE OF CALIBRATION CERTIFICATES BETWEEN THE EUROPEAN UNION AND THE USA Pressures for Equivalence of Measurement Standards and Mutual Recognition between National Metrology Laboratories (NMIs) [C] . Andrew Wallard, NCSL NCSL Workshop and Symposium . 1998

机译：欧盟与美国对衡量标准等同性的校准证书相互接受，以及国家计量实验室（NMIS）之间的衡量标准和相互承认
5. Project Management Practices and Key Factors for Success in FDA Human Factors Validations of Medical Devices and Combination Products =Prácticas de gestión de proyectos y factores clave para el exito en FDA validaciones de factores humanos de dispositivos [D] . Rojas, KM. 2020

机译：项目管理实践和FDA人类因素成功的关键因素医疗设备和组合产品的验证= FDA人类因素验证设备的项目管理和因素管理实践
6. A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement [O] . George Stergiou, Bruce Alpert, Stephan Mieke, -1

机译：血压测量装置验证的通用标准：医疗仪器发展协会/欧洲高血压学会/国际标准化组织（AAMI / ESH / ISO）合作声明
7. nyk of the Lviv University. Series Law KEYWORDS abuse of authority, abuse of power, abuse of official status, abuse of office acts of the European Union, international legal regulation, employment, right to free movement advocacy, advocate activity, advocacy science, advocatologie, theory of advocacy appeal proceeding, grounds to judgement revision, inconsistency of the court’s findings at first instance with the actual circumstances of the criminal proceedings, cancellation or alteration of the judgment charity organization, founder, assets of charity organization, constituent documents criminal proceedings, subjects of criminal proceedings, the suspect, the suspect law, criminal procedure, international standards employer’s duty, right to the moral injury compensation, social insurance from an industrial accident, social need, labour dispute forms of the legal actions of the collective of employees historical and legal science department, scientific activity law enforcement equipment, individual legal act, the means of forming the content of the enforcement act, requirements for registration of individual legal act attributes (properties) of acts of law legal formula (construction), qualified corpus delicti of a crime, degree of social danger, crime-forming feature legal social community legal technique, technology, legal act, legal system, lawmaking legitimacy, investigation of crime, concept of criminalistics, criminalistics recommendations, tactical methods measures aimed at providing criminal proceedings, procedural sanction, monetary penalty, pre-trial investigation national implementation, forms of implementation, implementation practice, European states, international treaties participant, shareholder, partnership, acquisition, changing, suspension proof, probability, likelihood, credibility in evidence, reliability scientific school, research, development land, agricultural and environmental law, Lviv Scientific School land, agricultural and environmental law the High Council of Justice of Ukraine, the National Council of Justice of the Republic of Poland, judges’ independence, international standards of the judiciary the presumption of the labor legal personality OPEN JOURNAL SYSTEMS Journal Help USER Username Password Remember me Login NOTIFICATIONS View Subscribe LANGUAGE Select LanguageSubmit JOURNAL CONTENT Search Search Scope Search Browse By Issue By Author By Title Other Journals FONT SIZE Make font size smallerMake font size defaultMake font size larger INFORMATION For Readers For Authors For Librarians HOME ABOUT LOGIN REGISTER SEARCH CURRENT ARCHIVES ANNOUNCEMENTS Home > No 67 (2018) > Марін ONCE AGAIN ON THE RETROACTIVE EFFECT OF THE CRIMINAL LAW IN TIME IN THE ASPECT OF INDIRECT CRIMINALIZATION [O] . Oleksandr Marin 2018

机译：LVIV大学的尼克。系列律师关键词滥用权威，滥用权力，滥用官方地位，滥用欧盟办公室行为，国际法律监管，就业，自由运动倡导，倡导活动，倡导科学，倡导性宣传理论，倡导呼吁的理论，理由修改，法院调查结果的不一致事实，判决慈善组织的实际情况，取消或改变判决慈善机构，慈善组织的创始人，慈善机构资产，组成文件刑事诉讼，刑事诉讼主题，嫌疑人，嫌疑法，刑事诉讼，国际标准雇主的责任，道德伤害赔偿权，社会保险从工业事故，社会需求，劳动争端形式的员工历史和法律科学部的法律行为，科学活动执法设备，个人法律法案，制定执法法案的内容，法律法律公式（建设）行为的个人法律法案（属性），犯罪的合格犯罪，社会危险程度，犯罪形成特征法律社会社会法律技术，技术，法律法，法律制度，立法合法性，犯罪调查，犯罪概念，犯罪建议，战术方法旨在提供刑事诉讼，程序制裁，货币罚款，预审调查预审国家实施，执行形式，实施实践，欧洲国家，国际条约参与者，股东，伙伴关系，收购，不断变化，暂停证明，概率，可能性，可信度在证据，可靠性科学学校，研究，开发土地，农业和环境法，利沃科学校园，农业和环境法律议理乌克兰的冰，波兰共和国国家司法委员会，法官的独立，国际标准的司法部门劳动法人的推定开放期刊系统期刊帮助用户用户名密码记住我登录通知查看订阅语言选择lobsumberubmit期刊内容搜索搜索范围搜索按问题浏览作者标题在间接刑事定罪方面，再次对刑法的追溯效应及时

Human factors in the design of medical devices – approaches to meeting international standards in the European Union and USA

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