GB 2639-1990
Replaced
YY/T 1947-2025
Active
Industry standards-Medicine
YY/T 1947-2025 Recombinant collagen protein dressing
YY/T 1947-2025 Recombinant collagen protein dressing
Basic Information
Standard Code:
YY/T 1947-2025
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Medical materials
Publish Date:
2025-02-26
Implement Date:
2026-03-01
Pages:
12 pages
Scope
This document specifies the requirements, markings, and packaging of recombinant collagen dressings, and describes the corresponding testing methods.
This document applies to recombinant collagen dressings used for non-chronic wounds.
This document does not apply to recombinant collagen dressings containing antibacterial or pharmaceutical ingredients.
Development Information
Referenced Standards
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 1849-2022 Recombinant collagen protein
YY/T 1888-2023 Recombinant humanized collagen protein
中华人民共和国药典(2020年版 四部)
Related Standards
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