YY/T 1803-2021
Active
Industry standards-Medicine
YY/T 1803-2021 Polyvinyl alcohol hemostatic sponge
YY/T 1803-2021 Polyvinyl alcohol hemostatic sponge
Basic Information
Standard Code:
YY/T 1803-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Medical materials
Publish Date:
2021-09-06
Implement Date:
2022-09-01
Pages:
11 pages
Scope
This document specifies the basic performance requirements for disposable, sterile, non-absorbable polyvinyl alcohol hemostatic sponges (hereinafter referred to as hemostatic sponges) primarily made of polyvinyl alcohol polymer materials.
This document applies to non-absorbable polyvinyl alcohol hemostatic sponges that physically compress bleeding points by expanding in size after absorbing fluids.
This document does not apply to uncompressed polyvinyl alcohol sponges for absorbing fluids, nor to polyvinyl alcohol sponges containing any drugs or hemostatic components, absorbable components, or those with other therapeutic functions.
Development Information
Referenced Standards
中华人民共和国药典(2020年版 四部)
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
Related Standards
GB 2639-1990
Replaced
GB 2641-1990
Abolished
GB 2641-1990 Tube vial for antibiotic use
GB/T 2640-1990
Replaced
GB/T 2640-1990 Injection vials for antibiotics
GB 2637-1995
Replaced
GB 2637-1995 Ampoule
GB/T 12414-1995
Replaced
GB/T 12414-1995 Pharmaceutical glass tube
GB 15980-1995
Abolished