GB/T 19633.2-2015 in English

《GB/T 19633.2-2015最终灭菌医疗器械包装 第2部分：成形、密封和装配过程的确认的要求》由TC200（全国消毒技术与设备标准化技术委员会）归口，主管部门为国家药品监督管理局。
本部分规定了最终灭菌医疗器械的包装过程的开发与确认要求。这些过程包括了预成形无菌屏障系统、无菌屏障系统和包装系统的成形、密封和装配。
本部分适用于工业、医疗机构对医疗器械的包装和灭菌。
本部分不包括无菌制造医疗器械的包装要求。对于药物与器械的组合，还可能有其他要求。

GB/T 19633.2-2015 Packaging for terminally sterilized medical devices - Part 2 Validation requirements for forming, sealing and assembly processes

1 Scope

This part of GB/T 19633 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

This part is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.

This part does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

2 Normative references

The following referenced document is 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.

ISO 11607-1 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 following terms and definitions apply.

3.1
expiry date
indication of the date, by which the product shall be used, expressed at least as the year and month


3.2
installation qualification; IQ
process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification
[ISO/TS 11139: 2006]

3.3
labeling
written, printed, electronic or graphic matter affixed to a medical device or its packaging system; or accompanying a medical device

Note: Labelling is related to identification, technical description and use of the medical device but excludes shipping documents.

3.4
operational qualification; OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures
[ISO/TS 11139: 2006]

3.5
packaging system
combination of the sterile barrier system and protective packaging
[ISO/TS 11139:2006]

3.6
performance qualification; PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification
[ISO/TS 11139: 2006]

3.7
preformed sterile barrier system
sterile barrier system that is supplied partially assembled for filling and final closure or sealing
Example: Pouches, bags and open reusable containers
[ISO/TS 11139: 2006]

3.8
process development
establishing the nominal values and limit(s)for critical process parameters


3.9
product
result of a process
[GB/T 19000-2008]

Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Validation of packaging processes
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) Process development
Bibliography