GB 18278-2000
Replaced
YY 0451-2023
Active
Industry standards-Medicine
YY 0451-2023 Portable infusion devices for single use—Non electrically driven
YY 0451-2023 Portable infusion devices for single use—Non electrically driven
Price:
$ 31.00
Basic Information
Standard Code:
YY 0451-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2023-09-05
Implement Date:
2026-09-15
Pages:
20 pages
Scope
This document specifies the basic requirements and corresponding test methods for non-electrically driven portable infusion pumps (hereinafter referred to as infusion pumps) for single use.
This document is applicable to infusion pumps for continuous (fixed or adjustable) fluid delivery and/or self-controlled fluid delivery for neurological, intravascular, or subcutaneous applications.
Note: The sites of neurological applications include the spine, intrathecal or subarachnoid space, brain ventricles, supra-arachnoid space, extradural space, or interdural space. Neurological applications of anesthetics can be locally injected to affect most parts of the human body (such as limbs) and include plexus blockade (such as brachial plexus blockade or single nerve blockade). The process of neurological applications includes continuous infusion of local anesthetics into the wound.
Development Information
Replace the following standards
Referenced Standards
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
YY 0286.1-2019 Infusion sets for special purpose—Part 1:Infusion sets for single use with micropore filters
ISO 80369-7
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 8368-1998 Infusion sets for single use
GB 8368-2005 Infusion sets for single use, gravity feed
GB 8368-2018 Infusion sets for single use—Gravity feed
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
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 0916.1-2014 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements
YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements
YY/T 0916.6-2022 Small-bore connectors for liquids and gases in healthcare applications—Part 6:Connectors for neuraxial applications
Adopt standards
ISO 28620:2020
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced