1.1 本指南的目标是推荐一种通用的标签格式（跨制造商和各种植入物），内容和信息的相对位置是植入物整体包装标签内最终植入物选择所必需的。 1.2 本指南建议对单独加工和包装的肌肉骨骼植入物进行包装标签，以便在使用时打开，通常在手术室中。 1.3 本指南确定了必要的“高优先级”标签内容，并建议最终用户在手术室环境中准确识别植入物的信息布局和位置。 1.4 这一目标是通过创建植入物包装标签的分区次级区域或单独标签来实现的，以统一地呈现该信息。 1.5 本指南的作者确定了监管要求、制造/分销和植入物识别的竞争需求。通过我们的工作组的努力，我们认识到，如果制造商选择实施这些建议，平衡这些竞争需求可能需要改变制造商的内部流程，重新标记其整个库存（在单个时间点或在规定的时间段内），或接受植入物包装标签上的重复信息。没有发现任何其他折衷方案可以实现制造商之间统一植入物标签设计的主要目标。 1.6 本指南无意限制或规定整个包装标签内容。 1.7 本指南的目的不是取代现有的监管要求（只是为了增加或补充现有的监管标签要求）。 1.8 本指南不阻止使用或应用多种语言；然而，本指南中定义的植入物选择子标签（ISSL）不鼓励使用一种以上的语言。选择的语言由制造商决定，并应由终端用户和设备销售所在辖区的监管要求决定。还应考虑使用国际符号，以避免在可能的情况下需要多个ISSL。 1.9 本指南的使用和实施是可选的，由植入物制造商自行决定。实施时应考虑以下因素: 1.9.1 任何矫形植入物标签的内容和布局都应受到风险管理活动的影响，所有标签格式都应经过验证。 1.9.2 如果内部风险管理活动建议偏离本指南，则不鼓励制造商实施部分适用本指南中原则和建议的混合标签。 1.10 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.11 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.12 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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 植入式医疗器械标签通常会导致各种标签格式和信息优先级。这种差异不仅存在于不同的制造商中，也存在于不同的植入物类型中。 3. 目前，标签设计和布局是由给定制造商开发的，代表着平衡内部需求（如制造、分销和营销）、不同市场内的监管要求和最终用户需求（由对其标签设计执行“消费者声音”反馈的单个制造商确定）。 4.2 对于任何给定的制造商来说，这一过程以及标签信息竞争包装上可用“不动产”的方式通常会导致标签信息的优先级变化和高度可变的标签设计。 这种可变性对患者护理的影响在已发表的文献中没有很好的记录。来自的文章 AAOS立即 2009年描述了围绕标签可变性的潜在问题，并提供了其影响的轶事证据。 3. 4.3 没有已发表的文献表明植入物标签的变异性对患者安全有明确和决定性的影响。尽管缺乏证据，但各种相关个人和组织（外科医生、手术室护士、医院管理人员、产品代表和制造商）的轶事观察和输入表明，植入物标签的标准化有潜在的好处，尽管尚未得到证实。 4.4 本指南的作者认为，需要强调的是，不存在公认的标签有效性验证方法。 当前的验证方法包括使用正式客户问卷对现有标签设计进行客户反馈的各种方法，通过个人投票进行非正式客户反馈，以及内部制造商驱动的研究。本指南中提出的标签建议尚未被验证为比目前使用的其他现有植入物标签更有效或更无效。 4.5 这些建议是通过ASTM赞助的工作组的合作制定的，该工作组的代表来自大型和小型骨科植入物制造商、骨科外科医生（特别是美国骨科医师学会生物医学工程委员会）、医疗设施管理员、手术室护士、美国。 S、 食品和药物管理局（FDA）和加拿大医疗保健系统。任务组利用了来自先前制造商标签倡议的“消费者之声”反馈，并结合任务组中各最终用户的输入。该过程没有确定任何给定的植入物标签格式是否有效，但仅尝试对信息进行优先排序，并为该信息推荐一种通用格式。制造商可以确定替代格式可能对其内部流程更有效，并选择不遵循这些建议。

1.1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implant’s overall package labeling. 1.2 This guide recommends package labeling for musculoskeletal based implants individually processed and packaged with the intent of being opened at the point of use, typically in the operating room. 1.3 This guide identifies the necessary, “high priority” label content and recommendations for the layout and location of information for accurate implant identification by the end users in the operating room environment. 1.4 This goal is achieved by creating a partitioned, secondary area of an implant’s package label or a separate label to present this information uniformly. 1.5 The authors of this guide identified the competing needs of regulatory requirements, manufacturing/distribution, and implant identification. It is recognized through our task group’s efforts that, if a manufacturer elects to implement these recommendations, balancing these competing needs may necessitate changing a manufacturer’s internal processes, relabeling their entire inventory (either at a single point in time or over a defined time period), or accepting duplicate information on an implant’s package label. No additional compromises that would allow the primary goal of uniform implant label design across manufacturers were identified. 1.6 It is not the intent of this guide to limit or dictate overall package labeling content. 1.7 It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing regulatory label requirements). 1.8 The use or application of multiple languages is not prevented by this guide; however, use of more than one language is discouraged on the implant selection sublabel (ISSL) defined in this guide. The language of choice is left to the manufacturer and should be dictated by the end user and regulatory requirements in the jurisdictions where the device is marketed. International symbols should also be considered to avoid the need for multiple ISSLs where possible. 1.9 Use and implementation of this guide is optional and at the sole discretion of the implant’s manufacturer. It shall be implemented with the following considerations: 1.9.1 The content and layout of any orthopedic implant label should be influenced by risk management activities and all label formats should be validated. 1.9.2 If internal risk management activities recommend deviation from this guide, the manufacturer is discouraged from implementing a hybrid label that partially applies the principles and recommendations in this guide. 1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.11 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. 1.12 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 Implantable medical device labeling often results in a variety of label formats and information prioritization. This variability can be seen not only across different manufacturers but also across different implant types. 3 At present label design and layout is developed by a given manufacturer and represents balancing internal needs (such as manufacturing, distribution, and marketing), regulatory requirements within various markets, and end user needs (as identified by individual manufacturers performing “voice of the consumer” feedback on their label designs). 4.2 At no fault to any given manufacturer, this process, along with the manner in which label information competes for available “real estate” on a package, often leads to variable prioritization of label information and highly variable label designs. The impact of this variability on patient care is not well documented within the published literature. An article from AAOS Now in 2009 described potential issues around label variability and gave anecdotal evidence of its impact. 3 4.3 No published literature demonstrating a clear and conclusive impact on patient safety resulting from implant label variability was identified. Despite this lack of evidence, anecdotal observations and input from various involved individuals and organizations (surgeons, operating room nurses, hospital administrators, product representatives, and manufacturers) suggests a potential, although unproven, benefit for an increased standardization of implant labeling. 4.4 The authors of this guide believe it is important to highlight that no universally accepted method for validation of a label’s effectiveness exists. Current validation methods consist of varying methods of customer feedback on an existing label design using formal customer questionnaires, informal customer feedback through individual polling, and internal manufacturer-driven studies. The label recommendations presented within this guide have not been validated as more or less effective than other existing implant labels currently in use. 4.5 These recommendations have been developed through the collaboration of an ASTM-sponsored task group with representation from large and small orthopedic implant manufacturers, orthopedic surgeons (specifically the Biomedical Engineering Committee from the American Academy of Orthopedic Surgeons), healthcare facility administrators, operating room nurses, the U.S. Food and Drug Administration (FDA), and the Canadian Healthcare System. The task group utilized “voice of consumer” feedback from previous manufacturer label initiatives combined with input from various end users on the task group. This process did not identify any given implant label format as being more or less effective but only attempts to prioritize information and recommend a universal format for this information. A manufacturer may determine that an alternative format may be more effective for its internal processes and elect not to follow these recommendations.