HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 0671-2021 English PDF

US$569.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0671-2021: Medical devices-Sleep apnoea breathing therapy- Masks and application accessories
Status: Valid

YY/T 0671: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0671-2021English569 Add to Cart 5 days [Need to translate] Medical devices-Sleep apnoea breathing therapy- Masks and application accessories Valid YY/T 0671-2021
YY/T 0671-2021English569 Add to Cart 5 days [Need to translate] Medical devices-Sleep apnoea breathing therapy- Masks and application accessories Valid YY/T 0671-2021
YY 0671.1-2009English150 Add to Cart 0--9 seconds. Auto-delivery Sleep apnoea breathing therapy. Prat 1: Sleep apnoea breathing therapy devices Obsolete YY 0671.1-2009

PDF similar to YY/T 0671-2021


Standard similar to YY/T 0671-2021

YY/T 0636.1   YY 0600.2   YY 0600.1   YY/T 0486   YY/T 0339   

Basic data

Standard ID YY/T 0671-2021 (YY/T0671-2021)
Description (Translated English) Medical devices-Sleep apnoea breathing therapy- Masks and application accessories
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 30,381
Date of Issue 2021-09-06
Date of Implementation 2024-05-01
Issuing agency(ies) State Drug Administration
Summary This standard applies to masks and their accessories for connecting sleep apnea therapy equipment to patients. This standard specifies requirements for masks and accessories, including any connections required to connect the patient connection port on the sleep apnea therapy device to a patient receiving sleep apnea therapy (such as nasal masks, vents, and headgear) . See standard YY 9706.270 (ISO 80601-2-70) for requirements on sleep apnea therapy equipment. This standard and YY 9706.270 (ISO 80601-2-7

YY/T 0671-2021: Medical devices-Sleep apnoea breathing therapy- Masks and application accessories


---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 C46 Pharmaceutical Industry Standard of the People's Republic of China YY 0671-2021 Replace YY 0671:2-2011 Medical Devices Sleep Apnea Therapy Masks and Application Accessories (ISO 17510:2015, MOD) According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: Released on 2021-09-06 Implemented on 2024-05-01 Released by the State Drug Administration

table of contents

Preface III Introduction V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Information provided by the manufacturer3 4:1 Overview 3 4:2 Markings on the protective packaging3 4:3 Attached Document 3 5 Structural Requirements 4 5:1 Mask connector 4 5:2 Biocompatibility4 5:3 * Protection against rebreathing 5 5:4 Cleaning, disinfection and sterilization5 5:5 * Breathing in single fault condition 6 5:6 Breathing system filter 6 6 Vibration and noise 6 Appendix A (Informative) Basic Principles 7 Appendix B (Normative Appendix) Exhaust Flow Test Procedure 10 Appendix C (Normative) Air Resistance (Pressure Drop) 12 Appendix D (Normative) Anti-asphyxia valve pressure test 13 Appendix E (Normative Appendix) Breathing under a single fault state --- Determination of inspiratory and expiratory resistance 15 Appendix F (Normative Appendix) Rebreathing of CO2 17 Appendix G (Normative Appendix) Vibration and Noise 19 Appendix H (informative appendix) Information guide provided by the manufacturer 20 Appendix I (informative appendix) involves basic principles 21 Reference 23 YY 0671-2021

foreword

All technical contents of this standard are mandatory: This standard is drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY 0671:2-2011 "Sleep Apnea Therapy Part 2: Masks and Application Accessories", and YY 0671:2- Compared with:2011, the main technical changes except editorial modifications are as follows: --- The test for the single failure condition of nasal mask rebreathing has been deleted, because the patient can breathe through the mouth in this environment (see 5:3:2); ---The sleep apnea treatment equipment standard used in conjunction with this standard has been changed from YY 0671:1 to YY 9706:270 (see Section 1 chapter): This standard uses the redrafted method to revise and adopt ISO 17510:2015 "Medical Device Sleep Apnea Therapy Mask and Application Accessories pieces": The technical differences between this standard and ISO 17510:2015 and their reasons are as follows: --- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the adjustment situation The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows: ● Replace IEC 61672-1:2013 with GB/T 3785:1, which is equivalent to the international standard; ● Replaced ISO 4135:2001 with GB/T 4999, which is equivalent to the international standard; ● Replaced IEC 60601-1:2005 Amd1:2012 with the revised international standard GB 9706:1; ● Replace ISO 4871:1996 with GB/T 14574, which is equivalent to the international standard; ● Replaced ISO 10993-1:2009 with GB/T 16886:1, which is equivalent to the international standard; ● Replaced ISO 14937:2009 with GB/T:19974, which is equivalent to the international standard; ● Replaced ISO 23328-1:2003 with YY/T 0753:1, which is equivalent to the international standard; ● Replaced ISO 23328-2:2002 with YY/T 0753:2, which is equivalent to the international standard; ● Replaced ISO 17664:2004 with YY/T 0802-2020, which adopts international standards; ● Replaced ISO 5356-1:2015 with YY/T 1040:1, which is equivalent to the international standard; ● Replaced ISO 5356-2:2012 with YY 1040:2, which is equivalent to the international standard; ● Replace ISO 80601-2-70:2015 with YY 9706:270, which adopts international standard: This standard has made the following editorial changes: --- Deleted Appendix J; --- Corrected editorial errors in ISO 17510:2015: ● Change 6 in parentheses after "sleep apnea treatment equipment" in the note of Figure A:1 to 7; ● Refer to 5:3 "Note: For the measurement method of average flow rate, refer to Appendix C of YY 9706:270-2021 in Appendix A:2, and refer to the Table C:1" is changed to "Note: Refer to:201:12:1:103 in YY 9706:270-2021 for the measurement method of the average flow rate, and its record reference See Table:201:104"; ● Adjust the corresponding relationship between the letter number and the content under 4:3 in Appendix A:2, that is, adjust the content of p) to r) and the content of q) Adjust the content to p), and adjust the content of r) to q) so as to correspond to the content of the text; ● Change the 3 in brackets after “traffic source” in D:4b) to 4: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: YY 0671-2021 This standard was proposed by the State Drug Administration: This standard is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116): This standard was drafted: Tianjin Yihe Jiaye Medical Technology Co:, Ltd:, Shanghai Medical Device Testing Institute: The main drafters of this standard: Zhuang Zhi, Zhao Weidong, Zhou Mingzhao, Wang Wei, Jia Wenxiang, Xu Chang: The previous releases of the standards replaced by this standard are as follows: ---YY 0671:2-2011: YY 0671-2021

Introduction

Sleep apnea is a clinically significant intermittent absence of normal breathing during sleep: Sleep apnea Risk awareness has increased significantly, and the use of sleep apnea therapy devices has become more common: This standard covers the use of equipment Basic safety and essential performance requirements for face shields and other applied accessories for patient protection: See Appendix A for the rationale for chapters, clauses and definitions marked with an asterisk (*): Conforms to safety and security as indicated in ISO 16142:2006 See Appendix I for the basic principles of performance: YY 0671-2021 Medical Devices Sleep Apnea Therapy Masks and Application Accessories

1 Scope

This standard applies to masks and their accessories for connecting sleep apnea therapy equipment to patients: This standard specifies the face shields and accessories requirements, including those required to connect the patient connection port on the sleep apnea therapy device to a patient receiving sleep apnea therapy: Any attachments (such as nasal masks, vents, and headgear): See YY 9706:270 for requirements on sleep apnea therapy equipment: This standard and YY 9706:270 constitute sleep apnea treatment The two parts of the system, the typical components involved are shown in Figure A:1: This standard does not include requirements for oral appliances:

2 Normative references

The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 3785:1 Electroacoustic sound level meters Part 1: Specifications (GB/T 3785:1-2010, IEC 61672-1:2002, IDT) GB/T 4999 Terminology of anesthesia breathing equipment (GB/T 4999-2003, ISO 4135:2001, IDT) GB 9706:1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (GB 9706:1-2020, IEC 60601-1:2012, MOD) GB/T 14574 Marking and verification of noise emission values of acoustic machines and equipment (GB/T 14574-2000, eqvISO 4871: 1996) GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process (GB/T 16886: 1-2011, ISO 10993-1:2009, IDT) GB/T:19974 Sterilization characteristics of healthcare products and development, validation and routine control of sterilization process for medical devices General requirements for (GB/T:19974-2018, ISO 14937:2009, IDT) YY/T 0466:1-2016 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1: General Requirements Seek (ISO 15223-1:2012, IDT) YY/T 0753:1 Respiratory system filters for anesthesia and respiration Part 1: Salt test method for evaluating filtration performance (YY/T 0753:1-2009, ISO 23328-1:2003, IDT) YY/T 0753:2 Breathing system filters for anesthesia and respiration Part 2: Non-filtering aspects (YY/T 0753:2-2009, ISO 23328-2:2002, IDT) YY/T 0802-2020 Handling of medical devices Information provided by medical device manufacturers (ISO 17664:2017, MOD) YY/T 1040:1 Conical joints for anesthesia and respiration equipment Part 1: Cone head and cone sleeve (YY/T 1040:1-2015, ISO 5356-1:2004, IDT) YY 1040:2 Conical joints for anesthesia and respiratory equipment Part 2: Threaded load-bearing joints (YY 1040:2-2008, ISO 5356- 2:2006) YY 9706:270 Medical Electrical Equipment Part 2-70: Particulars for Basic Safety and Essential Performance of Sleep Apnea Therapy Equipment Requirements (YY 9706:270-2021, ISO 80601-2-70:2015, MOD) ISO 3744:2010 Acoustic sound pressure method for the determination of sound power levels of noise sources and sound energy levels Approximate free-field engineering measurements above reflecting surfaces YY 0671-2021

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0671-2021_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0671-2021_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 0671-2021_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0671-2021_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 [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 0671-2021?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0671-2021 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.