YY/T 0681.16-2019 Test methods for sterile medical device package - Part 16: Test for climatic stressing of packaging system
1 Scope
This part of YY/T 0681 specifies a unified benchmark for laboratory evaluation of the ability of sterile medical device packaging systems to provide protection against damage or change for products under the climatic stressing that may be encountered during the circulation cycle.
This part is applicable as an independent test to evaluate the climatic stressing of packaging systems; it is also applicable as a conditioning method for packaging systems in single packages before undergoing tests required for overnight or two-day delivery.
This part is not applicable to the test for climatic stressing of packaging systems for refrigerated, frozen, or low-temperature storage and transportation.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
climatic stressing
conditioning of packaging system test samples by exposing them to temperature and humidity conditions for a specified period of time, so as to simulate the expected set storage and circulation system conditions
3 General
Devices transported in the circulation environment (regardless of the mode of transportation) will experience various climatic and physical environments during different periods of the year as they are shipped to various locations (especially for import and export). This part is designed to provide guidance for the establishment of climatic stressing on packaging systems due to climatic conditions and durations likely to be encountered during transportation, in order to evaluate the ability of the packages to provide protection for the contents or devices during circulation.
Foreword I
1 Scope
2 Terms and definitions
3 General
4 Significance and application
5 Apparatus
6 Test specimens
7 Procedure
8 Report
Bibliography
Standard
YY/T 0681.16-2019 Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system (English Version)
Standard No.
YY/T 0681.16-2019
Status
valid
Language
English
File Format
PDF
Word Count
3500 words
Price(USD)
105.0
Implemented on
2020-6-1
Delivery
via email in 1 business day
Detail of YY/T 0681.16-2019
Standard No.
YY/T 0681.16-2019
English Name
Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system
YY/T 0681.16-2019 Test methods for sterile medical device package - Part 16: Test for climatic stressing of packaging system
1 Scope
This part of YY/T 0681 specifies a unified benchmark for laboratory evaluation of the ability of sterile medical device packaging systems to provide protection against damage or change for products under the climatic stressing that may be encountered during the circulation cycle.
This part is applicable as an independent test to evaluate the climatic stressing of packaging systems; it is also applicable as a conditioning method for packaging systems in single packages before undergoing tests required for overnight or two-day delivery.
This part is not applicable to the test for climatic stressing of packaging systems for refrigerated, frozen, or low-temperature storage and transportation.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
climatic stressing
conditioning of packaging system test samples by exposing them to temperature and humidity conditions for a specified period of time, so as to simulate the expected set storage and circulation system conditions
3 General
Devices transported in the circulation environment (regardless of the mode of transportation) will experience various climatic and physical environments during different periods of the year as they are shipped to various locations (especially for import and export). This part is designed to provide guidance for the establishment of climatic stressing on packaging systems due to climatic conditions and durations likely to be encountered during transportation, in order to evaluate the ability of the packages to provide protection for the contents or devices during circulation.
Contents of YY/T 0681.16-2019
Foreword I
1 Scope
2 Terms and definitions
3 General
4 Significance and application
5 Apparatus
6 Test specimens
7 Procedure
8 Report
Bibliography
