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YY 0777-2023 English PDF

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Upon your order, we will start to translate YY 0777-2023_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.

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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). Avoidance of Double Taxation Agreements (DTAs) between Singapore and 100+ Countries: https://www.iras.gov.sg/taxes/international-tax

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Q: Should I purchase the latest version YY 0777-2023?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0777-2023 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.

US$169.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0777-2023: (Radio frequency hyperthermia equipment)
Status: Valid

YY 0777: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0777-2023	169	Add to Cart	3 days	(Radio frequency hyperthermia equipment)	Valid
YY 0777-2010	349	Add to Cart	3 days	Radio frequency hyperthermia equipment

Similar standards

YY 0778 YY 0950 YY 0903 YY/T 0776

Basic data

Standard ID: YY 0777-2023 (YY0777-2023)
Description (Translated English): (Radio frequency hyperthermia equipment)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C42
Classification of International Standard: 11.040.60
Word Count Estimation: 8,894
Date of Issue: 2023-01-13
Date of Implementation: 2026-01-15
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements and test methods for radio frequency hyperthermia equipment. This standard applies to radio frequency hyperthermia equipment. This standard does not apply to radiofrequency ablation equipment.

YY 0777-2023: (Radio frequency hyperthermia equipment)

---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 Standard of the People's Republic of China Replace YY 0777-2010 Radio frequency hyperthermia equipment Released on 2023-01-13 2026-01-15 Implementation Released by the State Drug Administration

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 0777-2010 "Radio Frequency Hyperthermia Equipment". Compared with YY 0777-2010, except for structural adjustment and editorial changes In addition, the main technical changes are as follows. --- Deleted the content of the composition (see Chapter 4 of the.2010 edition); --- Changed the output power requirements and test methods (see 4.2, 5.3, 5.3, 6.3 of the.2010 edition); --- Changed the temperature measurement requirements and test methods (see 4.3, 5.4, 5.4, 6.4 of the.2010 edition); --- Changed the temperature control requirements and test methods (see 4.4, 5.5, 5.5, 6.5 of the.2010 edition); --- Changed the functional requirements and test methods (see 4.5, 5.6, 5.6, 6.6 of the.2010 edition); --- Removed the appearance requirements and test methods (see 5.7, 6.7 of the.2010 edition); --- Changed the safety requirements and test methods (see 4.7, 5.8, 5.8, 6.8 of the.2010 edition); --- Changed the environmental test requirements and test methods (see 4.8, 5.9, 5.9, 6.9 of the.2010 edition); ---Changed the test conditions and the requirements of the required instrument tooling (see 5.1, 6.1 of the.2010 edition); ---Deleted inspection rules, signs, instructions for use, packaging, transportation, storage requirements (see Chapter 7~9 of the.2010 edition chapter). Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee (SAC/TC10/SC4) of the National Medical Electrical Appliances Standardization Technical Committee. The previous versions of the documents replaced by this document are as follows. ---YY 0777-2010. Radio frequency hyperthermia equipment

1 Scope

This document specifies the requirements and test methods for radio frequency hyperthermia equipment (hereinafter referred to as equipment). This document applies to radio frequency hyperthermia equipment. This document does not apply to radiofrequency ablation devices.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document. GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance GB 9706.203-2020 Medical Electrical Equipment Part 2-3.Particular Requirements for Basic Safety and Essential Performance of Shortwave Therapy Equipment GB/T 14710 Environmental requirements and test methods for medical electrical appliances

3 Terms and Definitions

The following terms and definitions defined in GB 9706.1 and GB 9706.203-2020 apply to this document. 3.1 The electromagnetic field with a frequency of 3MHz~120MHz is used to act on the human body in the form of external radiation to heat the treatment area to achieve Devices for tumor treatment or adjuvant therapy. 3.2 Automatic temperature control mode temp-autocontrolmode The equipment can automatically adjust the radio frequency output to stabilize the temperature of the corresponding parts of the patient within a certain range above and below the temperature control target temperature model.

4 requirements

4.1 Operating frequency The operating frequency of the equipment shall not exceed ±2% of the nominal value. 4.2 Output power 4.2.1 The device should be able to display the RF output power in watts (W), and the output power can be adjusted. 4.2.2 The rated output power should not be less than 500W, and the output power error should not be greater than ±20%. 4.3 Temperature measurement 4.3.1 The equipment should be able to measure and display the temperature of at least 5 different parts at the same time. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0777-2023_English be delivered?

Answer: Upon your order, we will start to translate YY 0777-2023_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 0777-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0777-2023_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+ countries

Question 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 Sales@ChineseStandard.net. 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 0777-2023?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0777-2023 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.