|
US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0109-2024: Medical ultrasonic nebulizer
Status: Valid YY/T 0109: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0109-2024 | English | 279 |
Add to Cart
|
3 days [Need to translate]
|
Medical ultrasonic nebulizer
| Valid |
YY/T 0109-2024
|
| YY 0109-2013 | English | 319 |
Add to Cart
|
3 days [Need to translate]
|
Medical ultrasonic nebulizer
| Obsolete |
YY 0109-2013
|
| YY 0109-2003 | English | 639 |
Add to Cart
|
5 days [Need to translate]
|
Medical ultrasonic nebulizer
| Obsolete |
YY 0109-2003
|
| YY/T 0109-1993 | English | 359 |
Add to Cart
|
3 days [Need to translate]
|
(General technical conditions ultrasonic nebulizer)
| Obsolete |
YY/T 0109-1993
|
PDF similar to YY/T 0109-2024
Basic data | Standard ID | YY/T 0109-2024 (YY/T0109-2024) | | Description (Translated English) | Medical ultrasonic nebulizer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 14,110 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 0109-2013 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements for medical ultrasonic nebulizers and specifies the corresponding test methods. This standard applies to medical ultrasonic nebulizers that use ultrasonic waves to atomize liquid drugs. | YY/T 0109-2024: Medical ultrasonic nebulizer---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 11.040.60
CCSC41
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0109-2013
Medical ultrasonic nebulizer
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
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.
This document replaces YY/T 0109-2013 "Medical Ultrasonic Atomizer". Compared with YY/T 0109-2013, except for structural adjustment and editing
In addition to the changes in performance, the main technical changes are as follows.
--- Added the term and definition of "total amount of atomization" (see 3.2);
--- Changed the term and definition of "atomization rate" (see 3.3, 3.2 of the.2013 edition);
--- Deleted the term and definition of "equivalent volume particle size" (see 3.3 of the.2013 edition);
--- Changed the term and definition of "volume median particle size" (see 3.4, 3.4 of the.2013 edition);
--- Added the term and definition of "aerodynamic mass median particle size" (see 3.5);
--- Added the requirements and test methods for "total amount of ultrasonic atomization" (see 4.2 and 5.2);
--- Changed the requirements and test methods for "atomized particle distribution characteristics" (see 4.6 and 5.6, 4.5 and 5.5 of the.2013 edition);
--- Deleted the requirements and test methods for "continuous working time" (see 4.7 and 5.10 of the.2013 edition);
--- Deleted the requirements and test methods for "power adaptability" (see 4.8 and 5.11 of the.2013 edition);
--- Changed the requirements and test methods of "Environmental test" (see 4.12, 4.11 of the.2013 edition);
--- Deleted the requirements of "Inspection Rules" (see Chapter 6 of the.2013 edition);
--- Deleted the "marking" requirements (see Chapter 7 of the.2013 edition).
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 Medical Ultrasonic Equipment Subcommittee of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10/SC2).
This document was drafted by. Hubei Medical Device Quality Supervision and Inspection Institute, Chengdu Weixin Electronic Science and Technology University New Technology Co., Ltd., Jiangsu
YUYUE MEDICAL EQUIPMENT CO., LTD.
The main drafters of this document are. Wu Chengzhi, Wang Zhijian, Wang Xinyang, Mei Jie, Zhou Pan, Li Jing, Wei Yan, Li Sijin, Jiang Shilin, Wang Luwei and Zhao Ran.
The previous versions of this document and the documents it replaces are as follows.
---YY 0109-1993 was first issued in.1993, revised for the first time in.2003, and revised for the second time in.2013;
---This is the third revision.
Medical ultrasonic nebulizer
1 Scope
This document specifies the requirements for medical ultrasonic nebulizers (hereinafter referred to as "nebulizers") and describes the corresponding test methods.
This document applies to medical ultrasonic nebulizers that use ultrasound to atomize liquid drugs.
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 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY/T 1420 Environmental requirements and test methods for medical ultrasonic equipment
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility
Requirements and tests
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The electrical frequency that excites the ultrasonic oscillation of the nebulizer.
Note. The unit of ultrasonic oscillation frequency is megahertz (MHz).
3.2
Nebulization quantity
For a given filling volume, the total volume or total mass of liquid that the nebulizer can atomize.
Note. The unit of total atomization volume is milliliters (mL) or grams (g).
3.3
Nebulization rate
The volume or mass of liquid atomized by the atomizer per unit time.
Note. The unit of atomization rate is milliliters per minute (mL/min) or grams per minute (g/min).
3.4
When the particles are sorted by size, the volume of particles larger than it and smaller than it each accounts for 50% of the total volume of the particles.
Particle size.
Note. The unit of volume median particle size is micrometer (μm).
3.5
When the particles are sorted by aerodynamic size, the mass of particles larger and smaller than it each accounts for a portion of the total mass of the particles.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0109-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 0109-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 0109-2024_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0109-2024_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 0109-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0109-2024 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.
|