T/SHBX 005-2023 Active Group standards

T/SHBX 005-2023 Disposable medical device packaging film that can be sterilized

T/SHBX 005-2023 Disposable medical device packaging film that can be sterilized

Publish Date: 2023-05-11 Implement Date: 2023-06-11 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: T/SHBX 005-2023
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Disinfection and sterilization
Publish Date: 2023-05-11
Implement Date: 2023-06-11
Pages: 16 pages

Scope

This document specifies the product classification, requirements, test methods, inspection rules, labels and markings, packaging, transportation, storage, etc. of sterilizable medical device packaging films (hereinafter referred to as "packaging films").
This document is applicable to medical device packaging films made from polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), and polybutylene terephthalate (PBT) as the main raw materials, which are sterilized by ethylene oxide.

Development Information

Word Count: 21 Thousand words Pages: 16 pages

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 1040.3-2006 Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets GB/T 2410-1980 Transparent plastics—Transmissivity and haze test GB/T 2410-2008 Determination of the luminous transmittance and haze of transparent plastics GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2918-1998 Plastics—Standard atmospheres for conditioning and testing GB/T 2918-2018 Plastics—Standard atmospheres for conditioning and testing GB/T 6672-2001 Plastics film and sheeting—Determination of thickness by mechanical scanning GB/T 6673-2001 Determination of length and width of plastics film and sheeting GB/T 8808 GB/T 9639.1-2008 Plastics film and sheeting—Determination of impact resistance by the free-falling dart methord—Part 1:Staircase methord GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products QB/T 1130-1991 Test Method for the Tear Strength of Plastic at Right Angles QB/T 2358-1998 Plastic film packaging bag heat seal strength testing method GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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