|
US$289.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1306-2024: Steam therapy apparatus
Status: Valid YY/T 1306: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1306-2024 | English | 289 |
Add to Cart
|
3 days [Need to translate]
|
Steam therapy apparatus
| Valid |
YY/T 1306-2024
|
| YY/T 1306-2016 | English | 179 |
Add to Cart
|
3 days [Need to translate]
|
Steam therapy apparatus
| Valid |
YY/T 1306-2016
|
PDF similar to YY/T 1306-2024
Basic data | Standard ID | YY/T 1306-2024 (YY/T1306-2024) | | Description (Translated English) | Steam therapy apparatus | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 14,118 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Older Standard (superseded by this standard) | YY/T 1306-2016 | | Issuing agency(ies) | State Drug Administration | YY/T 1306-2024: Steam therapy apparatus---This is a DRAFT version for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
CCSC42
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1306-2016
Fumigation therapy device
Released on 2024-07-08
2025-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Categories 1
5 Requirement 3
6 Test methods 4
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 1306-2016 Fumigation Therapy Device. Compared with YY/T 1306-2016, except for structural adjustments and editorial changes,
In addition to the above, the main technical changes are as follows.
--- Changed the terms and definitions of closed fumigation and open fumigation (see 3.2, 3.3, 3.2, 3.3 of the.2016 edition);
--- Added terms and definitions for steam generator (see 3.4);
--- Changed the classification content (see Chapter 4, Chapter 4 of the.2016 edition);
--- Deleted working conditions (see 5.1 of the.2016 edition);
--- Changed the requirements for fumigation temperature (see 5.1, 5.2 of the.2016 edition);
--- Changed the requirements for anti-dry burning function (see 5.3, 5.4 of the.2016 edition);
--- Changed the requirements for safety protection functions (see 5.4, 5.5 of the.2016 edition);
--- Changed the requirements for instruction manual (see 5.6, 5.8 of the.2016 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 Physical Therapy Equipment Subcommittee of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10/SC4).
This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Tianjin Medical Device Review and Inspection Center, Henan Xiangyu Medical
Medical Equipment Co., Ltd. and Shanghai Daosheng Medical Technology Co., Ltd.
The main drafters of this document are Chen Xingyu, Zheng Kun, Zhang Wenjie, Li Manfei, He Yongzheng, Shen Qingfeng and Zhou Huilin.
The previous versions of the documents replaced by this document are as follows.
---First published in.2016 as YY/T 1306-2016;
---This is the first revision.
Fumigation therapy device
1 Scope
This document specifies the classification and requirements of fumigation therapy devices (hereinafter referred to as "therapeutic devices") and describes the corresponding test methods.
This document applies to fumigation therapy devices (without medicine).
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 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 terms and definitions defined in GB 9706.1 and the following apply to this document.
3.1
A medical electrical device with temperature control function that generates steam by heating the liquid medicine to fumigate the affected area.
3.2
Closed steam therapy
The steam and treatment area are isolated from the surrounding environment.
3.3
Open steam therapy
Both the steam and the treatment area are exposed to the surrounding environment.
3.4
steam generator
The device for vaporizing medicinal liquid consists of a heating unit and a decoction container.
4 Categories
According to the treatment part, it is divided into local treatment device and systemic treatment device.
According to the treatment method, it is divided into open and closed treatment devices.
Figure 1, Figure 2 and Figure 3 show schematic diagrams of three types of therapeutic apparatuses.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1306-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 1306-2024_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 1306-2024_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1306-2024_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 1306-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1306-2024 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.
|