GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
1 Scope
This part of GB/T 19633 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
This part is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
This part does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
This part does not describe a quality assurance system for control of all stages of manufacture.
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 (including any amendments) applies.
ISO 5636-5:2003 Paper and board - Determination of air permeance and air resistance (medium range) - Part 5: Gurley method
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aseptic presentation
introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination
3.2
bioburden
population of viable microorganisms on or in a product or sterile barrier system
[ISO/T 11139:2006]
3.3
closure
means used to close a sterile barrier system where no seal is formed
Note: For example, a sterile barrier system can be closed by a reusable container gasket or sequential folding to construct a tortuous path.
3.4
closure integrity
characteristics of the closure, which ensures that it prevents the ingress of microorganisms under specified conditions
Note: See also 3.8.
3.5
expiry date
indication of the date, by which the product can be used, expressed at least as the year and month
3.6
labeling
written, printed, electronic or graphic matter affixed to a medical device or its packaging system; or accompanying a medical device
Note: Labeling is related to identification, technical description and use of the medical device but excludes shipping documents.
3.7
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
——diagnosis, prevention, monitoring, treatment or alleviation of disease;
——diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
——investigation, replacement, modification, or support of the anatomy or of a physiological process;
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials and preformed sterile barrier systems
6 Design and development requirements for packaging systems
7 Information to be provided
Annex A (Informative) Guidance on medical packaging
Annex B (Informative) Standardized test methods and procedures that may be used to demonstrate compliance with the requirements of this part of GB/T 19633
Annex C (Normative) Test method for resistance of impermeable materials to the passage of air
Bibliography
