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1. The Direction are stipulated by the Ministry of Labor with aim to assist the business entities to produce safety assessment reports for collaborative robots in accordance with Article 21 of Standards governing Prevention of Industrial Robots Hazards (hereinafter referred to as the “Standards”).
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2. The terms used in the Direction are defined as follow:
(1) Certification Body: The institutions that have established the product certification system of ISO/IEC 17065, and acquired qualification as Accreditation body from the Central Competent Authority, Machinery Directives of European, ISO 10218 or other equivalent standards (such as ANSI/RIA R15.06, JISB 8433 or UL1740) for Robots safety testing and certification.
(2) Safety Certification Report: The Report issued by the Certification Body in accordance with Annex I.
(3) Design Change: Refers to the changes to the range of motion, safety design, performance levels (PL), categories, safety integrity levels (SIL) and hardware fault tolerance of collaborative Robots.
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3. Employers shall convene relevant personnel in accordance with the provisions of Paragraph 4 of Article 21 of the Standards to carry out safety assessment on the following matters and make the safety assessment report for record preservation upon the usage of collaborative Robots:
(1) The brief introduction to the operation or process of the Collaborative Robots as shown in Annex II.
(2) Safety management plans as shown in Annex III.
(3) Safety Certification Report or Declaration of Conformity as shown in Annex I, I-1 and I-2.
(4) Safety procedures and reports of the Commissioning test as shown in Annex IV.
(5) Safety Procedures and reports of the Initial start-up as shown in Annex V.
(6) Automatic inspection plan and inspection record form, as shown in Annex VI and VI-1.
(7) Emergency response plan as shown in Annex VII.
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4. Employers shall take necessary preventive equipment and measures in accordance with the preceding matters of safety assessment.
Labor inspection agency shall review the safety assessment report produced by employers and confirm that the on-site safety management situation is consistent with the content of such report upon implementation of on-site inspection.
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5. Employers shall conduct the initial installation of Collaborative Robots together with relevant personnel of the business entities and the original manufacturer experts, and provide adequate guards for the commissioning test. Initial start-up begins after commissioning test completed.