Standard No.:	YY/T 0681.1-2018
Chinese Name:	无菌医疗器械包装试验方法 第1部分：加速老化试验指南
English Name:	Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
Professional Classification:	C31 General and microsurgical devices
Issued by:
Issued on:	2018-12-20
Implemented on:	2020-01-01
Status:	VALID
Replace:	YY/T0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
Language:	English
File Format:	PDF
Word Count:	8000 words
Price(USD):	240 (USD)
Delivery:	via email in 1-3 business day

YY/T 0681.1-2018 Test methods for sterile medical device packageDPart 1:Test guide for accelerated aging

1 Scope

This part of YY/T 0681 provides guidance for developing accelerated aging protocols.

This part is applicable to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in GB/T 19633.1-2015 and the physical properties of their component packaging materials.

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

This part is not applicable to real-time aging protocols.

Note 2: The accelerated aging test addresses the sterile barrier systems in whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this part.

Note 3: It is essential that real-time aging test be performed 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, distribution, handling, and shipping events, are beyond the scope of this part. See YY/T 0681.15 for the resistance against shipping challenges of sterile barrier systems.

Note 5: This part does not address extreme climactic conditions that may exist in the shipping and handling environment. See YY/T 0681.16 for climatic adaptability test of sterile barrier systems.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 4857.2 Packaging - Basic tests for transport packages - Part 2: Temperature and humidity conditioning
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 19633.1-2015 and the following apply.

3.1

accelerated aging