YY/T 1798-2021Intrauterine compression balloon for single use (English PDF)
一次性使用宫腔压迫球囊
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 1798-2021 is the English-translated version of 一次性使用宫腔压迫球囊.
YY/T 1798-2021 is the Chinese pharmaceutical industry standard for the single-use intrauterine compression balloon, the balloon inflated in the uterus to control or reduce postpartum haemorrhage by pressing on the uterine wall.
It sets the classification, the requirements and the test methods, the marks, packaging and instructions for use, and the rules for transport, storage and the sterile shelf life, covering the balloon and its volume and burst pressure, the catheter and the drainage channel, the connections and their tightness, the materials and their biological evaluation, and sterility. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 1798-2021
National Standard of the People's Republic of China
- Classification
- C 36
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Categories
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the classification, requirements, test methods, signs and packages of single-use intrauterine compression balloons (hereinafter referred to as intrauterine compression balloons).
Packaging and use instructions, transportation and storage, and sterilization expiration date.
This standard applies to single-use intrauterine compression for temporary control or reduction of postpartum uterine bleeding by mechanical compression to stimulate the uterus balloon.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 1962.1 Syringes, injection needles and other medical devices - 6% (Luer) conical joints - Part 1: General requirements
GB/T 1962.2 Syringes, needles and other medical devices - 6% (Luer) conical connectors - Part 2: Locking connectors
GB/T 9969 General Principles of Instruction Manual for Industrial Products
GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods
GB/T 15812.1-2005 Non-Intravascular Catheters Part 1: General Performance Test Methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process
YY 0285.1-2017 Intravascular catheters for single-use sterile catheters Part 1: General requirements
YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1: General Requirements Pharmacopoeia of the People's Republic of China (2020 Edition)
3 Categories
3.1 Composition and structure
3.1.1 The uterine cavity compression balloon is usually composed of a catheter tip, a uterine balloon, a catheter tube, a seat, and a valve.
3.1.2 The basic structure of the uterine cavity compression balloon is shown in Figure 1.If it can meet the requirements of this standard, other structural types can also be used. manufacture Therefore, when designing the intrauterine compression balloon, clinical needs, such as the suitability of the tip length, should be considered.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 1962.1Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
- GB/T 1962.2Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 9969General principles for preparation of instructions for use of industrial products
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 15812.1-2005Catheters other than intravascular catheters -- Part 1: Test methods for common for properties
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 15812.1-2005 — Catheters other than intravascular catheters -- Part 1: Test methods for common for properties
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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YY/T 1798-2021
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