【CODEX】YYT 0681.1-2018 无菌医疗器械包装试验方法

第1部分：加速老化试验指南-英文版

无菌医疗器械包装试验方法 第1部分：加速老化试验指南

Test methods for sterile medical device package  - Part 1: Test guide for accelerated aging

1    范围

1    Scope

      YY/T 0681的本部分规定了设计加速老化方案的指南。

This part of YY/T 0681 specifies the guide for designing accelerated aging protocols.

      本部分适用于快速确定GB/T 19633.1—2015中所规定的无菌屏障系统无菌完整性和其包装材料 组件物理特性受所经历时间的影响。

This part is applicable for rapidly determining the effects, due to the passage of time, on the sterile integrity of the sterile barrier system as defined in GB/T 19633.1—2015 and the physical properties of their component packaging material.

注1:   用YY/T 0681的本部分获得的信息用以支持医疗器械无菌屏障系统的有效期限（即货架寿命）。

Note 1:   Information obtained using this part of YY/T 0681 may be used to support expiration date claims for medical device sterile barrier systems (i.e. shelf life).

      本部分不适用于实时老化方案。

This part is not applicable for real-time aging protocol.

注2:   加速老化试验中涉及含或不含器械的无菌屏障系统整体，本部分不涉及在新产品开发中或评价时要求的无菌屏障系统材料与器械相互作用的相容性。

注3:   实时老化试验是用来确定加速老化试验结果的一项基本老化研究。

注4:   本部分不涉及无菌屏障系统确认的方法，包括其受机械加工、灭菌过程、流通、搬运和运输等事件的影响无 菌屏障系统的抗运输挑战的能力见YY/T 0681.15。

注5:   本部分不涉及模拟运输环境中可能经受的极限气候条件的影响。无菌屏障系统的气候应变能力试验 见YY/T 0681.16。

Note 2:   The accelerated aging test addresses the whole sterile barrier system with or without device. This part does not address the compatibility of sterile barrier materials with device interactions required during new product development or evaluation.

Note 3:   Real-time aging test is a basic aging study used to confirm the accelerated aging test results.

Note 4:   Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this part. Refer to YY/T 0681.15 for ability of the sterile barrier system in resisting challenges during shipping.

Note 5:   This part does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to YY/T 0681.16 for adaptability of the sterile barrier system to climatic stressing.

2    规范性引用文件

2    Normative References

      下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本文件。

The following referenced documents are indispensable for the application of this document. For dated references, only the dated edition is applicable to this document. For undated references, the latest edition (including all the revisions) is applicable to this document.

      GB/T 4857.2 包装  运输包装件基本试验  第2部分：温湿度调节处理

      GB/T 4857.2 Packaging - Basic tests for transport packages - Part 2: Temperature And Humidity Conditioning

      GB/T 19633.1—2015   最终灭菌医疗器械包装  第1部分：材料、无菌屏障系统和包装系统的要求

      GB/T 19633.1—2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司，作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商，CODEX科译拥有更多的医学资深语言专家，能实现40多种语言对的互译，接受更高难度的医学领域的项目挑战，并在最短时间内适应以给出最合理的解决方案。保证最高质量，100%按时交付，高效、完善的售后保障是CODEX科译给客户的用心承诺。