GB/T 8600-1988
Replaced
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
Price:
$ 26.00
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
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
Related Standards
GB 8599-1988
Replaced
GB 8599-1988 Specifications for automated autoclave sterilizer
GB 15981-1995
Replaced
GB 15981-1995 Evaluating method and standard for the efficacy of disinfection and sterilization
GB 15982-1995
Replaced
GB 15982-1995 Hygienic standard for disinfection in hospitals
GB 16383-1996
Replaced
GB 16383-1996 Quality control standards for radiation sterilization of medical and hygienical products
GB 18279-2000
Replaced