GB/T 19633.1-2024 English PDF (GBT19633.1-2024)

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GB/T 19633.1-2024: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
CCS C 47
GB/T 19633.1-2024 / ISO 11607-1:2019
Replacing GB/T 19633.1-2015
Packaging for Terminally Sterilized Medical Devices – Part
1: Requirements for Materials, Sterile Barrier Systems and
Packaging Systems
(ISO 11607-1:2019, IDT)
ISSUED ON: MAY 28, 2024
IMPLEMENTED ON: DECEMBER 1, 2025
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 8
2 Normative References ... 8
3 Terms and Definitions ... 9
4 General Requirements ... 16
5 Materials, Preformed Sterile Barrier Systems and Sterile Barrier Systems ... 18
6 Design and Development for Packaging Systems ... 24
7 Usability Evaluation for Aseptic Presentation ... 26
8 Packaging System Performance and Stability ... 27
9 Packaging System Validation and Changes ... 28
10 Inspection Immediately Prior to Aseptic Presentation ... 29
11 Information to be Provided ... 29
Annex A (Informative) Guidance on Medical Packaging ... 31
Annex B (Informative) Standardized Test Methods, Guides and Procedures That Can
be Used to Demonstrate Conformity with the Requirements of This Document ... 34
Annex C (Normative) Test Method for Resistance of Impermeable Materials to the
Passage of Air ... 52
Annex D (Informative) Environmental Aspects ... 53
Annex E (Informative) Draft Guidance on Ways to Differentiate a Sterile Barrier
System from Protective Packaging ... 54
Annex F (Normative) Risk Management ... 59
Annex G (Informative) Risk Management for Medical Device Packaging - Rationale
for Requirements ... 64
Bibliography ... 76
Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for
Standardization – Part 1: Rules for the Structure and Drafting of Standardizing Documents.
This Document is Part 1 of GB/T 19633 Packaging for Terminally Sterilized Medical Devices.
GB/T 19633 has published the following parts:
--- Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems;
--- Part 2: Validation Requirements for Forming, Sealing and Assembly Processes.
This Document replaced GB/T 19633.1-2015 Packaging for Terminally Sterilized Medical
Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems.
Compared with GB/T 19633.1-2015, the major technical changes of this Document are as
follows besides the structural adjustments and editorial modifications:
--- Change the description of scope (see Clause 1 of this Edition; Clause 1 of the 2015
Edition);
--- Add the terms "control", "supervision", "terminally sterilized", "expiration date",
"hazard", "intended use", "intended purpose", "process", "reasonably foreseeable
misuse", "risk" and their definitions (see 3.5, 3.10, 3.28, 3.29, 3.32, 3.33, 3.34, 3.35 and
3.36 of this Edition);
--- Delete the terms "packaging material" and "recycled material" and their definitions (see
3.9 and 3.14 of the 2015 Edition);
--- Add the requirements for risk management (see 4.2, Annex F of this Edition);
--- Add the sampling requirements for materials and sterile barrier systems (see 4.3 of this
Edition);
--- Add the requirements for the microbial barrier properties of materials [see 5.1.7h) of this
Edition];
--- Add the requirements for confirming compliance with ISO11607-2 and the sub-clause
for reversible seals or closures [see 5.1.9 a), f) of this Edition];
--- Add requirements for aseptic access (see 6.1.2 of this Edition);
--- Add performance evaluation requirements for selection and confirmation of materials
and preformed aseptic barrier systems (see 6.2.2 of this Edition);
--- Add labeling requirements on protective packaging of aseptic liquid products (see 6.2.5
of this Edition);
--- Add requirements for usability evaluation of aseptic access (see Clause 7 of this Edition);
--- Add general requirements for performance and stability of packaging systems (see 8.1 of
this Edition);
--- Change the test objects of performance tests (see 8.2.2 of this Edition; 6.3.4 of the 2015
Edition);
--- Add requirements for forming documents to determine the worst-case principle (see 8.2.3
of this Edition);
--- Change the time when real-time aging starts (see 8.3.4 of this Edition; 6.4.4 of the 2015
Edition);
--- Add packaging system validation and changes (see Clause 9 of this Edition);
--- Add requirements for inspection immediately prior to aseptic presentation (see Clause 10
of this Edition).
This Document equivalently adopted ISO 11607-1:2019 Packaging for Terminally Sterilized
Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging
Systems.
The following minimal editorial changes were made to this Document:
--- Incorporate the amendments of ISO11607-1:2019/Amd.1:2023, and the outer margins of
the involved clauses are marked with vertical double lines (‖);
--- Add NOTE 2 to 3.8;
--- Adjust the format of Table B.1, adding a column "Chinese standard number
corresponding to the reference standard", and merged "reference standard" and "name"
into one column;
--- Added NOTE to Annex E;
--- Change the numbers of the NOTEs in F.2 and F.7.
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not assume the responsibility to identify these patents.
This Document was proposed by National Meical Products Administration.
This Document shall be under the jurisdiction of National Technical Committee on Disinfection
Technology and Equipment of Standardization Administration of China (SAC/TC 200).
Drafting organizations of this Document: Guangdong Medical Devices Quality Surveillance
and Test Institute; Shanghai MicroPort Medical (Group) Co., Ltd.; DuPont (China) Research and
Packaging for Terminally Sterilized Medical Devices – Part
1: Requirements for Materials, Sterile Barrier Systems and
Packaging Systems
1 Scope
This Document specifies 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 Document does not cover all requirements for sterile barrier systems and packaging
systems for medical devices that are manufactured aseptically. Additional requirements can be
necessary for drug/device combinations.
This Document does not describe a quality assurance system for control of all stages of
manufacture.
This Document does not apply to packaging materials and/or systems used to contain a
contaminated medical device during transportation of the item to the site of reprocessing or
disposal.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
ISO 5636-5 Paper and board – Determination of air permeance (medium range) – Part 5:
Gurley method
ISO 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation
requirements for forming, sealing and assembly processes
NOTE: GB/T 19633.2-2024 Packaging for ...