发布时间：2024-05-27 17:49:26 - 更新时间：2024年06月29日 15:22
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Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
Medical instruments - Packaging - Technical specification
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software — Part 2: Validation of software for medical device quality systems
本标准提供了用于确定医疗器械菌屏障系统中材料（或包装材料）的生物相容性试验的指南。 本标准不涉及包装材料的所有安全问题
Guide for biological evaluation of packaging materials for medical devices
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
YY/T 0681的本部分规定的试验方法能够以60%~100%的概率(见附录B)确定75 μm以上宽度的通道。本试验方法适用于至少一面透明的软材料包装和硬材料包装,这样密封区可以清晰地观察到
Test methods for sterile medical device package.Part 11:Determining integrity of seals for medical packaging by visual inspection
YY/T 0681的本部分规定了测定包装承受内压能力的程序。 胀破试验是对包装内部逐渐加压，直至包装破坏。 蠕变试验是施加一个规定的压力并保持规定的时间或直至包装破坏。 注：附录A给出了本标准规定的试验方法的精密度和偏倚的相关信息
Test methods for sterile medical device package.Part 3:Internal pressurization failure resistance of unrestrained packages
Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
Medical instruments - Packaging - Technical specification
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software — Part 2: Validation of software for medical device quality systems
本标准提供了用于确定医疗器械菌屏障系统中材料（或包装材料）的生物相容性试验的指南。 本标准不涉及包装材料的所有安全问题
Guide for biological evaluation of packaging materials for medical devices
Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
YY/T 0681的本部分规定的试验方法能够以60%~100%的概率(见附录B)确定75 μm以上宽度的通道。本试验方法适用于至少一面透明的软材料包装和硬材料包装,这样密封区可以清晰地观察到
Test methods for sterile medical device package.Part 11:Determining integrity of seals for medical packaging by visual inspection
YY/T 0681的本部分规定了测定包装承受内压能力的程序。 胀破试验是对包装内部逐渐加压，直至包装破坏。 蠕变试验是施加一个规定的压力并保持规定的时间或直至包装破坏。 注：附录A给出了本标准规定的试验方法的精密度和偏倚的相关信息
Test methods for sterile medical device package.Part 3:Internal pressurization failure resistance of unrestrained packages
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