Standard No.:	GB/T 19633.1-2024
English Name:	Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
Chinese Name:	最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求
Chinese Classification:	C47    Public medical equipment
Professional Classification:	GB    National Standard
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Source Content Issued by:	SAMR; SAC
Issued on:	2024-05-28
Implemented on:	2025-12-1
Status:	valid
Superseding:	GB/T 19633.1-2015 Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systems
Target Language:	English
File Format:	PDF
Word Count:	30000 words
Translation Price(USD):	900.0
Delivery:	via email in 1 business day

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. It 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. It does not describe a quality assurance system for control of all stages of manufacture. It 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 following documents are referred to in the text in such a way that some or all of their content constitutes 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. 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 terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2: 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: ——ISO Online browsing platform: available at https://www.iso.org/obp ——IEC Electropedia: available at http://www.Electropedia.org/ 3.1 aseptic presentation transfer of sterile contents from its sterile barrier system using conditions and procedures that minimize the risk of microbial contamination [Source: ISO 11139:2018, 3.13] 3.2 bioburden population of viable microorganisms on or in product and/or sterile barrier system [Source: ISO 11139:2018, 3.23] 3.3 closure means used to complete a sterile barrier system where no seal is formed Example: By a reusable container gasket or sequential folding to construct a tortuous path. [Source: ISO 11139:2018, 3.51, modified - The example has been added.] 3.4 closure integrity characteristics of a closure to minimize the risk of ingress of microorganisms [Source: ISO 11139:2018, 3.52] 3.5 control regulation of variables within specified limits [Source: ISO 11139:2018, 3.63] 3.6 expiry date date by which product shall be used Note: For the purpose of this document and ISO 11607-2, expiry date refers to the medical device in a sterile barrier system. The term “use by date” (3.29) is used to describe the shelf life of packaging materials and preformed sterile barrier systems prior to assembly into a sterile barrier system. [Source: ISO 11139:2018, 3.110, modified – Note has been added.] 3.7 labelling label, instructions for use and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents [Source: GB/T 42061-2022, 3.8]” 3.8 medical device instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical 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; ——supporting or sustaining life; ——control of conception; ——disinfection of medical devices; ——providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means Note 1: Products which may be considered to be medical devices in some jurisdictions but not in others include: ——items specifically intended for cleaning or sterilization of medical devices; ——pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for sterilization; ——disinfection substances; ——aids for persons with disabilities; ——devices incorporating animal and/or human tissues; ——devices for in vitro fertilization or assisted reproduction technologies. Note 2: The definition of medical device in the Regulations on supervision and management of medical devices in China is as follows: Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrators, materials, and other similar or related articles, directly or indirectly applied to the human body, including the required computer software. Their intended effects are mainly achieved through physical means rather than pharmacological, immunological or metabolic methods, or such methods may be involved but only play an auxiliary role. Their purposes are as follows: (I) diagnosis, prevention, monitoring, treatment or alleviation of disease; (II) diagnosis, monitoring, treatment, alleviation of or functional compensation for an injury; (III) investigation, replacement, modification, or support of the anatomy or of a physiological process; (IV) supporting or sustaining life; (V) control of conception; (VI) Providing information for medical or diagnostic purposes by examining samples derived from the human body. [Source: GB/T 42061-2022, 3.11, modified] 3.9 microbial barrier property of a sterile barrier system to minimize the risk of ingress of microorganisms [Source: ISO 11139:2018, 3.169] 3.10 monitoring continual checking, supervising, critically observing, or determining the status, in order to identify change from the performance level required or expected [Source: GB/T 23694-2013, 4.8.2.1, modified - The note has been deleted.] 3.11 packaging system combination of a sterile barrier system and protective packaging [Source: ISO 11139:2018, 3.192] 3.12 preformed sterile barrier system sterile barrier system (3.23) that is supplied partially assembled for filling and final closure or sealing Example: Pouches, bags and open reusable containers (3.17). [Source: ISO 11139:2018, 3.201, modified - The example has been added.] 3.13 product tangible result of a process

Contents Foreword i Introduction iv 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 5 Materials, preformed sterile barrier systems and sterile barrier systems 6 Design and development for packaging systems 7 Usability evaluation for aseptic presentation 8 Packaging system performance and stability 9 Packaging system validation and changes 10 Inspection immediately prior to aseptic presentation 11 Information to be provided Annex A (Informative) Guidance on medical packaging Annex B (Informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document Annex C (Normative) Test method for resistance of impermeable materials to the passage of air Annex D (Informative) Environmental aspects Annex E (Informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging Annex F (Normative) Risk management Annex G (Informative) Risk management for medical device packaging - Rationale for requirements Bibliography