ISO13485根据医疗器械的行业特点，新标准作了许多专业性规定。
ISO13485 in accordance with the medical devices industry characteristics, the new standard for many professional provisions.
　1.4.2.4记录控制规定："组织保存记录的期限应至少相当于组织所规定的医疗器械的寿命期，但从组织放行产品的日期起不少于2年，或按相关法规要求规定。"
1.4.2.4 recording control provisions:" organization for keeping records of the period should be at least equal to the organization under the medical equipment life period, but from a tissue product release date not less than 2 years, according to the relevant laws and regulations or requirements. "
　　2.5.5.2管理者代表的职责和权限c)要求，"确保在整个组织内提高满足法规要求和顾客要求的意识。"
2.5.5.2 management representative duties and powers C) requirements," ensuring the promotion to meet regulatory requirements and the awareness of customer requirements. "
　　3.5.6.2管理评审输入增加了"h)新的或修订的法规要求。"
3.5.6.2 input to management review adds" H ) new or revised requirements of the regulations. "
　　4.6.4工作作环境中增加了对产品清洁、防止污染、人员健康等方面的要求。
4.6.4 work environment to increase the product cleaning, pollution prevention, health and other aspects of the request.
　　5.7.1产品实现的策划中增加了风险管理的内容。
5.7.1 products to achieve the planned increase in the risk management of the content.
　　6.7.2.3顾客沟通中增加了"d)忠告性通知。"
6.7.2.3 customers to add a " d ) advice. "
　　7.7.3.1设计和开发策划b)指出，"适合于每个设计和开发阶段的评审、验证、确认和设计转换活动(注：设计和开发过程中设计转换活动可确保设计和开发输出在成为最终产品规范前得以验证，以确保其适于制造)。"
7.7.3.1 design and development planning of B ) points out," are appropriate to each design and development stage of the review, verification, validation and design activities ( Note: design and development process design activity can ensure that the design and development outputs a final product specification in front to verify, to ensure that it is suitable for manufacturing ). "
　　8.7.3.2设计和开发输入a)改为，"根据预期用途，规定的功能、性能和安全要求"，并增加了"e)风险管理的输出。"
8.7.3.2 design and development inputs a ) changed to," according to the intended use, the functions of regulation, performance and safety requirements", and added" E ) risk management of output. "
　　9.7.3.3设计和开发输出增加了"应保持设计和开发输出的记录(注：设计和开发输出的记录可包括规范、制造程序、工程图纸、工程或研究历程记录)"。
9.7.3.3 design and development to increase output of the" design and development should maintain output records ( Note: design and development output records may include the specification, manufacturing process, engineering drawings, work or study course record )".
　　10.7.3.4设计和开发评审的参加者增加了"其他专家人员。"
10.7.3.4 design and development review of participants increased " other expert personnel. "
　　11.7.3.5设计和开发的确认规定，"作为设计和开发确认活动的一部分，如国家或地区的法规要求，组织应实施医疗器械临床评价和／或性能评价。"
11.7.3.5 design and development validation rules," as the design and development validation activities, such as national or regional laws and regulations, the organization shall carry out clinical evaluation of medical devices and / or performance evaluation. "
　　12.7.4.2采购信息规定"按照7.5.3.2规定的可追溯性要求的范围和程度， 组织应保持相关的采购信息，如文件和记录。"
12.7.4.2 procurement information regulations" in accordance with the provisions of 7.5.3.2 traceability requirements of the scope and extent, the organization shall maintain the purchase information, such as files and records. "
　　13.7.5.1.1生产和服务提供的控制"总要求"，增加了"g)规定的标签和包装操作的实施"，并规定"组织应建立并保持每一批医疗器械的记录，以提供7.5.3规定的可追溯性的范围和程度的记录，并标明生产数量和批准销售的数量。每批的记录应加以验证和批准。"
The 13.7.5.1.1 control of production and service provision." General requirements", adding the "g ) defined labels and packaging for the implementation of the operation", and" the organization shall establish and maintain a number of medical records, to provide 7.5.3 provides traceability of the scope and degree of recording, and indicate the production quantity and approval the number of sales. Each batch of records shall be verified and approved. "
　　14.新标准增加了"产品的清洁和污染的控制(7.5.1.2.1)"，"安装活动(7.5.1.2.2)"，"服务活动　　 (7.5.1.2.3)"，"无菌医疗器械的专用要求(7.5.1.3)"条款。
14 new standard adds" cleanness and pollution control ( 7.5.1.2.1 )"," install activity ( 7.5.1.2.2 )"," service activity ( 7.5.1.2.3 )"," the special requirements for sterile medical devices ( 7.5.1.3 )" clause.
　　15.7.5.2生产和服务提供过程的确认增加了关于"确认对产品满足规定要求的能力有影响的生产和服务提供的计算机软件的应用"，以及对"灭菌过程"进行确认的内容。
15.7.5.2 validation of processes for production and increase on" confirmed that the products meet the requirements of the ability to have influence on the production and service of computer software applications", and the" sterilization process validation of content".
　　16.7.5.3条款规定了"组织应建立形成文件的程序，以确保返回组织的医疗器械均能被识别，且能与合格的产品区分开来"的要求，并对有源植人性医疗器械和植人性医疗器械规定了可追溯性的专用要求(7.5.3.2.2)，对状态标识作了规定(7.5.3.3)。
Provisions of 16.7.5.3." The organization shall establish a documented procedure to ensure the return, organization of medical equipment can be identified, and can distinguish the qualified product" requirements, and active planting for human medical equipment and plant human medical equipment provides traceability of special requirements (7.5.3.2.2 ), state identification provisions were made ( 7.5.3.3 ).
　　17.7.5.4顾客财产的"注"增加了"保密的健康信息"。
17.7.5.4 customer property "notes" with a "confidential health information".
18.8.2.1条款的标题改为"反馈"，增加了提供质量问题早期报警和评审生产后阶段的经验等内容，而不是ISO 9001标准8.2.1的顾客满意。因为顾客满意和顾客感知在法规中作为要求来实施都显得太主观。
The terms of the 18.8.2.1 headline read" feedback", increased the availability of quality problem of early warning and assessment after the production stage experience and other content, rather than the standard ISO 9001 8.2.1 customer satisfaction. Because customer satisfaction and perceived as a requirement in the regulations to implement seems to be too subjective.
　　19.8.2.4产品的监视和测量规定，"只有在策划的安排(见7.1)已圆满完成时，才能放行产品和交付服务"，而没有了"除非得到有关授权人员的批准，适用时得到顾客的批准 (ISO 9001标准8.2.4条款)"这种可以例外的任何前提。
19.8.2.4 monitoring and measurement of product requirements," only the planned arrangements ( see 7.1) have been satisfactorily completed, to the release of product and delivery of service", and not " unless approved by a relevant authority and, where applicable by the customer approval ( ISO 9001 standard 8.2.4 clause )" this exception if any.
　　对有源植人性医疗器械和植人性医疗器械还提出了专用要求，即"组织应记录检验和试验人员的身份"。
Active planting for human medical equipment and plant human medical equipment also proposed a special, namely" the organization shall record the inspection and test status of personnel".
　　20.8.3不合格品控制规定："组织应确保不合格品仅在满足法规要求的情况下才能实施让步接收，且应保持批准让步接收的人员身份的记录。"
20.8.3 control of nonconforming product provides:" the organization shall ensure that the unqualified goods only to meet the requirements of the regulations can be implemented under concession, approval and should maintain records of the identity of concession. "
　　21.8.5改进的8.5.1"总则"规定了"建立并实施忠告性通知发布和实施的程序"，以及处理顾客报怨的做法。还作出了"如果国家或地区法规要求通告符合规定报告准则的不良事件，组织应建立告知行政主管部门的形成文件的程序"的规定。
Improvement of 21.8.5 8.5.1" general" provisions of the" establish and implement advice issued and implemented the program", as well as handling customer complaints approach. Also made" if countries or regions and notices in accordance with the provisions of reporting adverse events, the organization shall establish administrative departments in charge of the documented procedures " provisions.