1.1 该实践为无人驾驶飞机系统(UAS)制造商提供了民航局(CAA)生产批准的要求，这些要求可能与CAA对无人驾驶UAS的适航批准相关联。 1.2 型号认证和生产证书（TC/PC）批准流程在航空业中根深蒂固。在国际上，这些流程在不同国家之间有很好的协调，但是这些流程可能会有所不同，这取决于国家的航空历史、政府组织、行业规模、安全文化等。TC/PC工艺产生了高度稳健的产品，符合航空法规要求的严格要求。TC/PC流程是传统载人航空安全记录的同义词，公众将期望UAS行业提供类似的安全性。1.2.1 国际民航组织2022年8月23日的国家信函AN 11/61-22/70提出了一个新的附件6-飞机运行，第四部分-国际运行-遥控飞机系统（UAS）。附件6第四部分中的标准和推荐做法（SARPs）适用于根据附件8-飞机适航性（TC）认证的RPAS的运行。国际民航组织国家信函和附件6第四部分的前言确定了三类无人驾驶飞机系统操作:开放式、特定和认证。这三类总结如下: 1.2.1.1 开放式类别的运营风险最低。如果操作是在规定的限制范围内进行的，如仅VLOS、与机场的规定距离、人员的接近程度、最大高度等，则不需要CAA的操作授权。与开放式类别操作相关联的UAS的生产通常不受CAAs的监督。 1.2.1.2 特定类别针对中等操作风险。在特定类别中，需要管理CAA的操作授权，CAA可以根据操作类型、UAS的复杂性以及操作人员的资格和经验施加限制。运营批准基于对安全风险评估的分析和缓解措施的应用，以将风险降低到可接受的水平。对于特定类别来说，重要的是降低的风险水平低于保证完全应用载人航空原则的水平，例如，低于TC/PC流程。用于分析安全风险的一种方法是JARUS特定（类别）操作风险评估（SORA）。SORA进一步将特定类别分为低风险、中风险和高风险。 1.2.1.3 认证类别涉及最高的运营风险。认证类别内的安全风险已经增加到与载人航空相当的水平，并且通常是这样监管的（例如，运营商认证、UAS型号认证、远程飞行机组许可等）。）. 1.2.2 在 图1 根据ICAO状态信函确定开放、特定和认证类别。此外，根据SORA，特定类别已被分为低、中和高风险。术语“最高”和“最低”用于区分与开放类别相关联的低风险和稳健性以及与认证类别相关联的高风险和稳健性。该实践解决了在与低、中和高风险相关的ICAO特定类别中运行的UA的生产要求。1.2.3 随着类别和相关风险的增加 图1 ，也是: (1) 生产授权需要满足的要求数量； (2) 需求结果的稳健性； (3) 申请人证明符合要求所需的严谨性； (4) 所制造的产品的最终质量；和 (5) 产品的可靠性。 1.2.4 TC/PC工艺仍然是产品操作中安全性和相应风险接受度的黄金标准。请注意，本实践提出的层级对应于特定类别的三个风险级别（低、中和高）。从第3层到第2层，需求的稳健性和生产严格性（数量或细节，或两者）有相当大的差异。第2层和第1层之间的差异较小。该图还显示了第1层和现有TC/PC流程之间的最小差异。换句话说，Tier 1与大多数CAA TC/PC需求具有高度的通用性；然而，一些要求的细节可能会有所不同，或者具有特定于管理CAA的独特国内适应性，或者两者兼而有之，这可能需要本实践范围之外的附加要求。 1.3 在这种实践中，使用了一种可扩展的基于风险的评估，类似于无人系统特定操作风险评估规则制定联合机构（JARUS SORA），用于确定基于CAA第1-3级的生产批准。 1.3.1 作为一个例子，结合了SORA操作安全目标(OSO)#2的欧洲联盟航空安全局(EASA)框架用于指导UAS制造商基于完整性和保证的生产稳健性水平（参考 附录X1 ).Tier 1是最高的生产稳健性，当与适航/型号认证相结合时，应该能够广泛地进行操作。第2层是中等稳健性，应使UAS制造商能够降低特定风险和开放操作。Tier 3是最低的稳健性，限制UAS制造商以更低的风险进行更具限制性的操作。评估的操作风险与制造商的生产严格程度相称。例如，用于高风险操作的UAS需要更严格的生产、质量标准和监督（参考 附件A1 ). 1.4 在这种实践中，为小型、中型和大型制造商提供了一个路线图，以通过管理CAA寻求生产批准。该标准路线图还允许公司将其组织从最初的第3层要求发展到高级第1层。1.5 该实践是在ASTM F38库的更广泛背景下有目的地设计的。尽管此处介绍的内容的原始源材料旨在作为独立文档，但ASTM工作组有意识地删除了任何冗余信息，转而采用参考性的“单一真实来源”方法。因此，在应用本标准时，必须考虑并整合所有相关的ASTM F38标准，以确保其全面、准确的实施。 1.6 当打算利用本实践中提供的信息作为生产批准的合规手段时，就其可接受的用途和应用咨询相应的管理机构（例如CAA）至关重要。要了解哪些机构已接受本标准（全部或部分）作为符合其监管要求（以下简称“规则”）的可接受手段，请参阅ASTM F38 webpage（www.ASTM.org/COMMITTEE/F38.htm）。 1.7 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ======意义和用途====== 4.1 本惯例适用于为其制造的UAS产品或物品寻求CAA管理生产批准的UAS制造商。物品供应商另有说明。 4.2 本规范用于标准化生产批准的质量和生产最佳实践。 4.3 在本实践中，为寻求生产批准的UAS制造商提供了最佳实践。这种做法可以支持管理CAA带来的附加要求。 4.4 通过建立质量、生产和符合CAA特定要求的最佳实践，UAS制造商可以申请CAA生产批准，如所示 图2 .

1.1 This practice provides unmanned aircraft systems (UAS) manufacturers with the requirements toward civil aviation authority (CAA) production approval that may be associated with a CAA airworthiness approval for UAS without people on board. 1.2 The Type Certification and Production Certificate (TC/PC) approval process is well-entrenched within the aviation industry. Internationally, these processes have good harmonization from country to country however those processes can be different depending on the country’s aviation history, governmental organization, size of industry, safety culture, etc. The TC/PC process results in a highly robust product that has undergone compliance to the rigor that aviation regulations require. The TC/PC process is synonymous with the safety record of traditional manned aviation and the public will expect similar safety from the UAS industry. 1.2.1 ICAO State letter AN 11/61-22/70, dated 23 August 2022 proposed a new Annex 6—Operation of Aircraft, Part IV—International Operations—Remotely Piloted Aircraft Systems (UAS). The Standards and Recommended Practices (SARPs) in Annex 6, Part IV are applicable to the operation of RPAS certificated in accordance with Annex 8—Airworthiness of Aircraft (TC). The ICAO State letter and the foreword to Annex 6, Part IV identifies three categories of unmanned aircraft systems operations: Open, Specific and Certified. These three categories are summarized below: 1.2.1.1 The Open category poses the lowest operational risk. No authorization to operate from the CAA is required if operations are conducted within defined limitations such as VLOS only, specified distances from aerodromes, proximity of persons, maximum altitude, etc. The production of the UAS associated with Open category operations are typically not overseen by CAAs. 1.2.1.2 The Specific category addresses the medium operational risk. Within the Specific category, operational authorization is required from the governing CAA who may impose restrictions or limitations based on the type of operation, the complexity of the UAS and the qualifications and experience of operating personnel. Operational approvals are based on analysis of a safety risk assessment and application of mitigation means to reduce risks to an acceptable level. Of significance to the Specific category is that the mitigated risk level is below that which warrants the full application of manned aviation principles, for example, below the TC/PC process. One methodology used to analyze safety risk is the JARUS Specific (category) Operational Risk Assessment (SORA). The SORA further divides the Specific category into Low, Medium, and High risk. 1.2.1.3 The Certified category deals with the highest operational risk. The safety risks within the Certified category have increased to an equivalent level as manned aviation and is typical regulated as such (for example, operator certification, UAS type certification, remote flight crew licensing, etc.). 1.2.2 In Fig. 1 , the Open, Specific, and Certified categories are identified per the ICAO state letter. Further, the Specific category has been broken into Low, Medium, and High risks per the SORA. The terms “highest” and “lowest” are used to differentiate the Low risk and robustness associated with the Open category and the High risk and robustness associated with the Certified category. This practice addresses the production requirements for UA operating in the ICAO Specific category associated with Low, Medium, and High risk. 1.2.3 As the categories and associated risks increase in Fig. 1 , so does the: (1) Number of requirements that need to be met for production authorization; (2) Robustness of the requirement outcomes; (3) Rigor required by the applicant to demonstrate compliance to the requirements; (4) Resulting quality of the product being made; and (5) Reliability of the product. 1.2.4 The TC/PC process remains the gold standard for safety and the corresponding acceptance of risk within the operation of the product. Note that the tiers proposed by this practice correspond to the Specific category’s three levels of risk (low, medium, and high). There is a sizable difference in the robustness of the requirements and the production rigor (number or details, or both) from Tier 3 to Tier 2. There are fewer differences between Tier 2 and Tier 1. The diagram also shows the minimal differences between Tier 1 and the existing TC/PC process. In other words, Tier 1 has a high degree of commonality with most CAA TC/PC requirements; however, the details of some requirements may vary or have unique domestic adaptations particular to the governing CAA, or both, that may necessitate additional requirements not captured by the scope of this practice. 1.3 In this practice, a scalable risk-based assessment similar to the Joint Authorities for Rulemaking of Unmanned Systems Specific Operations Risk Assessment (JARUS SORA) for determining CAA Tiers 1–3–based production approval is used. 1.3.1 As an example, the European Union Aviation Safety Agency (EASA) framework incorporating the SORA operational safety objectives (OSO) #2 was used to guide the UAS manufacturer’s level of production robustness based upon integrity and assurance (reference Appendix X1 ). Tier 1 is the highest production robustness that should enable broad access to operations when combined with airworthiness/type certification. Tier 2 is the medium robustness that should enable UAS manufacturers to lower risk Specific and Open operations. Tier 3 is the lowest robustness limiting UAS manufacturers to more restrictive operations with even lower risk. The assessed operational risk is commensurate with the manufacturer’s production rigor. For example, UAS intended for higher risk operations necessitate greater production rigor, quality standards, and oversight (reference Annex A1 ). 1.4 In this practice, a roadmap is provided for small, medium, and large manufacturers to pursue production approval through a governing CAA. This standard roadmap also allows companies to progress their organization from the initial Tier 3 requirements to advanced Tier 1. 1.5 This practice has been purposefully designed within the broader context of the ASTM F38 library. Although the original source materials for the content presented here were intended to function as standalone documents, the ASTM working group has consciously removed any redundant information in favor of adopting a referential "single-source-of-truth" approach. Consequently, when applying this standard, it is essential to consider and integrate all relevant ASTM F38 standards to ensure its comprehensive and accurate implementation. 1.6 When intending to utilize the information provided in this practice as a means of compliance for production approval, it is crucial to consult with the respective governing authority (for example, CAA) regarding its acceptable use and application. To find out which authorities have accepted this standard (in whole or in part) as an acceptable means of compliance to their regulatory requirements (hereinafter "the Rules"), please refer to the ASTM F38 webpage (www.ASTM.org/COMMITTEE/F38.htm). 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This practice is applicable to UAS manufacturers seeking a governing CAA production approval for UAS products or articles manufactured by themselves. Article suppliers are otherwise indicated. 4.2 This practice serves to standardize quality and production best practices for production approval. 4.3 In this practice, best practices for UAS manufacturers seeking production approval are provided. This practice may support additional requirements brought by the governing CAA. 4.4 Through establishing best practices in quality, production, and compliance to governing CAA specific requirements, the UAS manufacturer can apply for CAA production approval as illustrated in Fig. 2 .