|
US$519.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0339-2024: Suction catheters for use in the respiratory tract
Status: Valid YY/T 0339: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0339-2024 | English | 519 |
Add to Cart
|
5 days [Need to translate]
|
Suction catheters for use in the respiratory tract
| Valid |
YY/T 0339-2024
|
| YY/T 0339-2019 | English | 505 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Suction catheters for use in the respiratory tract
| Valid |
YY/T 0339-2019
|
| YY 0339-2009 | English | 230 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Suction catheter for use in the respiratory tract
| Obsolete |
YY 0339-2009
|
| YY 0339-2002 | English | 479 |
Add to Cart
|
3 days [Need to translate]
|
Suction catheter for use in the respiratory tract
| Obsolete |
YY 0339-2002
|
PDF similar to YY/T 0339-2024
Basic data | Standard ID | YY/T 0339-2024 (YY/T0339-2024) | | Description (Translated English) | Suction catheters for use in the respiratory tract | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 26,297 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 0339-2019 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the dimensions and requirements of suction catheters for respiratory tract. This standard applies to open and closed suction catheters made of flexible materials and intended for respiratory tract suction. This standard does not apply to suction catheters intended for use with flammable anesthetic gases or agents, lasers or electrosurgical equipment. | YY/T 0339-2024: Suction catheters for use in the respiratory tract---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.10
CCSC46
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0339-2019
Airway suction catheter
(ISO 8836.2019,MOD)
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 * General requirements 3
5 Materials 3
6 Design Requirements 4
7 Requirements for suction catheters provided sterile 9
8 Packaging 9
9 Information provided by the manufacturer 9
Appendix A (Informative) Basic Principles 12
Appendix B (informative) Hazard identification for risk assessment 15
Appendix C (Normative) Connection firmness test method 17
Appendix D (Normative) Residual vacuum test method 18
Appendix E (Informative) * Leakage test method 20
Reference 21
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting is required.
This document replaces YY/T 0339-2019 "Suction Catheters for Respiratory Tract". Compared with YY/T 0339-2019, except for the structural adjustment and compilation
In addition to logical changes, the main technical changes are as follows.
--- The restriction that only external joints of suction catheters can be provided on the suction catheters has been deleted (see 7.3.1 of the.2019 edition);
--- Added the internal connector of the suction catheter (see Figure 1, 6.5.2.7, 9.3.1, Appendix A 6.4);
--- Changed the terms and definitions (see Chapter 3, Chapter 3 of the.2019 edition);
--- Changed the test conditions for residual vacuum in closed suction catheters (see Appendix D, Appendix C of the.2019 edition).
This document is modified to adopt ISO 8836.2019 "Suction catheters for use in the respiratory tract".
The technical differences between this document and ISO 8836.2019 and their reasons are as follows.
--- Added normative references GB/T 4999 and GB/T 42062 to adapt to my country's technical conditions;
--- ISO 5356-1 was replaced by the normative reference YY/T 1040.1 to adapt to my country's technical conditions;
--- Replaced ISO 18562-1 with the normative reference YY/T 1778.1 to adapt to my country's technical conditions.
--- Replaced ISO 18190.2016 with the normative reference YY/T 1844-2022.The consistency between the two documents is
Modify to adapt to my country's technical conditions;
--- Change "closed suction catheter" to "suction catheter" (see 3.9) to adapt to my country's technical conditions;
--- Changed Figure 1 (see Figure 1) to adapt to my country's technical conditions;
--- Change "apply a pressure ≤40 kPa below atmospheric pressure" in the pipe body performance to "apply a negative pressure of at least 40 kPa" (see 6.6.2).
Adapt to the technical conditions of our country;
--- Added the minimum force requirements for the design specifications of Table 2 when the design specifications are 5mm (see Table 2) to adapt to the technical requirements of my country.
Technical conditions;
--- Added relevant requirements for instruction manual (see 9.3.3) to adapt to my country's technical conditions;
--- Added "open suction catheter" (see Appendix D) to adapt to my country's technical conditions;
--- Change "1" in Figure D.1 to "vacuum pump" and "2" to "flow meter" (see Appendix D) to adapt to my country's technical conditions;
--- Added the flow requirements for the design specification of 5mm in Table D.1 (see Appendix D) to adapt to my country's technical conditions.
Compared with ISO 8836.2019, the following editorial changes have been made to this document.
--- Change ISO 8836.2014 to YY 0339-2009 (see 3.18 in Appendix A);
--- Delete the obsolete reference ISO /T R11991;
--- Change the reference ISO 80601-2-74.2017 to YY 9706.274-2022.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This document was drafted by. Shanghai Institute of Medical Device Inspection, Guangzhou Weili Medical Device Co., Ltd., Medtronic (Shanghai)
Co., Ltd. and Yadu Medical Technology (Henan) Co., Ltd.
The main drafters of this document are. Yang Xiaoqing, Liu Jing, Xu Chang, Xu Hui, Wang Wei, Ni Jing, Guo Shaocong and Qian Xinyi.
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2002 as YY 0339-2002, first revised in.2009, and second revised in.2019;
---This is the third revision.
Introduction
This document contains the basic requirements and specification identification for open suction catheters and closed suction catheters made of flexible materials.
method.
To help medical personnel better select the most appropriate suction catheter for specific patients in clinical applications, this document proposes
The design specifications of the suction catheter are important because they determine the suction catheter's ability to fit the endotracheal tube or trachea.
When the incision cannula is used together, whether the two can cooperate well.
For explanations of the contents marked with asterisks* in this document, please see Appendix A.
Airway suction catheter
1 Scope
This document specifies the dimensions and requirements for suction catheters for use in the respiratory tract.
This document applies to open and closed suction catheters made of flexible materials intended for respiratory suction.
This document does not apply to suction catheters intended for use with flammable anesthetic gases or agents, lasers, or electrosurgical equipment.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 4999 Terminology for Anesthesia and Respiratory Equipment (GB/T 4999-2003, ISO 4135.2001, IDT)
GB/T 42062 Application of medical device risk management to medical devices (GB/T 42062-2022, ISO 14971.2019,
IDT)
YY/T 1040.1 Conical connectors for anesthesia and respiratory equipment Part 1.Cone head and cone sleeve (YY/T 1040.1-2015,
ISO 5356-1.2004, IDT)
YY/T 1778.1 Biocompatibility evaluation of respiratory gas pathways in medical applications Part 1.Evaluation and implementation in the risk management process
Test (YY/T 1778.1-2021, ISO 18562-1.2017, IDT)
YY/T 1844-2022 General requirements for airways and related equipment for anesthesia and respiratory equipment (ISO 18190.2016, MOD)
ISO 80369-7 Small-bore connectors for medical liquids and gases Part 7.Connectors for intravascular or subcutaneous applications
3 Terms and definitions
The terms and definitions defined in GB/T 4999 and GB/T 42062 and the following apply to this document.
3.1
A suction catheter (3.17) enclosed in a protective sleeve (3.8) allows it to be used in situations where the respiratory system cannot be directly exposed to air.
use.
3.2
A portion of a closed suction catheter (3.1) used for connection to an airway device.
3.3
Connector
A connector that connects two or more parts.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0339-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 0339-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 0339-2024_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0339-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. Question 5: Should I purchase the latest version YY/T 0339-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0339-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
|