PDF GB/T 19633.2-2024 English (GB/T 19633.2-2015: Older version)
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
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GB/T 19633.2-2024: PDF in English (GBT 19633.2-2024) GB/T 19633.2-2024
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).
Packaging for terminally sterilized medical devices - Part 2.
Validation requirements for forming, sealing and assembly
processes
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.
It does not cover all requirements for packaging medical devices that are manufactured
aseptically. Additional requirements can be necessary for drug/device combinations.
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.
3.1 aseptic presentation
transfer of sterile contents from its sterile barrier system using conditions and
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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