GB/T 19633.2-2024 PDF English
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GB/T 19633.2-2024: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT19633.2-2024
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
ICS 11.080.30
CCS C 47
GB/T 19633.2-2024 / ISO 11607-2.2019
Replacing GB/T 19633.2-2015
Packaging for terminally sterilized medical devices - Part 2.
Validation requirements for forming, sealing and assembly
processes
(ISO 11607-2.2019, IDT)
Issued on. MAY 28, 2024
Implemented on. DECEMBER 1, 2025
Issued by. State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 7
2 Normative references... 7
3 Terms and definitions... 7
4 General requirements... 14
5 Validation of packaging processes... 15
6 Assembly... 20
7 Use of reusable sterile barrier systems... 21
8 Sterile fluid-path packaging... 21
Appendix A (informative) Process development... 22
Appendix B (normative) Risk management... 24
References... 29
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents.
This document is Part 2 of GB/T 19633 Packaging for terminally sterilized medical
devices. GB/T 19633 has been published in 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 replaces GB/T 19633.2-2015 Packaging for terminally sterilized
medical devices - Part 2.Validation requirements for forming, sealing and assembly
processes. Compared with GB/T 19633.2-2015, in addition to structural adjustments
and editorial changes, the main technical changes are as follows.
-- The description of the scope has been changed (see Chapter 1; see Chapter 1 of
the 2015 edition);
-- The terms "aseptic presentation", "closure", "control", "medical device",
"microbial barrier", "monitoring", "process parameter", "process specification",
"process variable", "seal", "seal strength", "sterile", "terminally sterilized",
"hazard", "process" and "risk" and their definitions have been added (see 3.1,
3.2, 3.3, 3.7, 3.8, 3.9, 3.14, 3.15, 3.16, 3.22, 3.23, 3.24, 3.27, 3.29, 3.30 and
3.31);
-- The term "process development" and its definition have been deleted (see 3.8 of
the 2015 edition);
-- The risk management requirements have been added (see 4.2 and Appendix B);
-- The sampling requirements for materials and sterile barrier systems have been
added (see 4.3);
-- The requirements for determining process specifications have been added (see
5.1.3);
-- The requirement that the production of preformed sterile barrier systems and
sterile barrier systems shall meet the predefined sealing strength has been added
in operational qualification (see 5.3.2);
-- The requirements for medical devices with sterile fluid circuits marked have been
deleted (see 8.2 of the 2015 edition).
This document is identical to ISO 11607-2.2019 Packaging for terminally sterilized
medical devices - Part 2.Validation requirements for forming, sealing and assembly
processes.
The following minimal editorial changes are made to this document.
-- The amendments to ISO 11607-2.2019/Amd.1.2023 are incorporated, and the
outer margins of the clauses involved are marked with vertical double lines (ǁ);
-- The NOTE 2 is added to 3.7;
-- The note numbers in B.2 are changed.
Please note that some of the contents of this document may involve patents. The issuing
organization of this document does not assume the responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on
Sterilization Techniques and Equipment of Standardization Administration of China
(SAC/TC200).
Drafting organizations of this document. Guangdong Medical Devices Quality
Surveillance and Test Institute, Shanghai MicroPort Medical (Group) Co., Ltd., DuPont
(China) R&D Management Co., Ltd., Nanwei Medical Technology Co., Ltd., Shanghai
Jianzhong Medical Packaging Co., Ltd., Amcor Group Bemis Flexible Packaging
(Suzhou) Co., Ltd.
Main drafters of this document. Wan Yiyi, Li Ran, Qin Lei, Ding Yanqin, Wang
Youqiong, Qian Jun, Wang Fangying, Yuan Biyu, Li Yong, Li Ning, Song Yiqin, Wang
Qing.
The previous versions of this document and the documents it replaces are as follows.
-- First published in 2005 as GB/T 19633-2005 Packaging for terminally sterilized
medical devices;
-- The first revision was in 2015.The standard number and name were adjusted to
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices - Part
2.Validation requirements for forming, sealing and assembly processes;
-- This is the second revision.
1 Scope
This document specifies requirements for the 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes the requirements 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 19633.1-2024 Packaging for terminally sterilized medical devices - Part 1.
Requirements for materials, sterile barrier systems and packaging systems (ISO
11607-1.2019, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the
following addresses.
process of establishing by objective evidence that all key aspects of the process
equipment and ancillary system installation comply with the approved specification
4 General requirements
The sampling plans used for the selection and testing of materials, sterile barrier
systems or packaging systems shall be applicable to materials, sterile barrier systems
or packaging systems being evaluated. Sampling plans shall be based upon statistically
valid rationale.
5 Validation of packaging processes
The documentation shall summarize and reference all protocols and results, and
state conclusions regarding the validation status of the process.
Processes concerning forming, assembly, sealing or closing shall be covered by a
change-control procedure for documenting, verifying and authorizing changes.
6 Assembly
Packaging systems shall be assembled and filled according to the instructions based
on a validated process that enables sterilization in a defined sterilization process. These
instructions should include the configuration of contents and organizing inserts, total
weight, inner wrapping and absorbent materials.
7 Use of reusable sterile barrier systems
In addition to the requirements listed in Chapter 6, provisions in GB/T 19633.1-2024,
5.1.10 and 5.1.11 shall be followed (e.g. assembly, disassembly, maintenance, repair,
storage).
8 Sterile fluid-path packaging
Assembly of sterile fluid-path components and closures shall meet the requirements of
Chapter 5 and Chapter 6.
Appendix A
(informative)
Process development
Process development, while not a formal part of process validation, should be
considered as an integral part of forming and sealing. Process development or process
design requires an assessment to identify and evaluate.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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