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YY/T 0977-2023 English PDF

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YY/T 0977-2023: Anaesthetic and respiratory equipment - Oropharyngeal airways
Status: Valid

YY/T 0977: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0977-2023	English	359	Add to Cart	4 days [Need to translate]	Anaesthetic and respiratory equipment - Oropharyngeal airways	Valid	YY/T 0977-2023
YY/T 0977-2016	English	519	Add to Cart	3 days [Need to translate]	Anaesthetic and respiratory equipment--Oropharyngeal airways	Obsolete	YY/T 0977-2016

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Basic data

Standard ID	YY/T 0977-2023 (YY/T0977-2023)
Description (Translated English)	Anaesthetic and respiratory equipment - Oropharyngeal airways
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C46
Classification of International Standard	11.040.10
Word Count Estimation	18,186
Date of Issue	2023-09-05
Date of Implementation	2024-09-15
Older Standard (superseded by this standard)	YY/T 0977-2016
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements for oropharyngeal airways made of plastic and/or rubber materials (including oropharyngeal airways with reinforced inserts made of plastic and/or metal materials). This document does not specify flammability requirements for oropharyngeal airways. This document does not apply to metallic oropharyngeal airways and upper laryngeal airways without internal, integral sealing devices.

YY/T 0977-2023: Anaesthetic and respiratory equipment - Oropharyngeal airways

---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 CCS 46 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 0977-2016 Anesthesia and Respiratory Equipment Oropharyngeal Airways (ISO 5364.2016,MOD) Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration

Preface III Introduction IV 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Specifications and dimensions 2 4.1 Specification Marking 2 4.2 Size 2 5 Material 3 6 Design 3 7 Performance requirements 3 7.1 Resistance to flattening of the buccal part 3 7.2 Inner cavity patency 3 8 Sterility Guarantee3 9 Packaging of sterile supplied oropharyngeal airways4 10 mark 4 10.1 General 4 10.2 Use of symbols 4 10.3 Oropharyngeal Airway Marking 4 10.4 Unit packaging marking 5 10.5 Shelf or multi-unit packaging marking5 11 Information provided by the manufacturer5 Appendix A (Informative) Basic Principle 6 Appendix B (Normative) Test method for flattening resistance of buccal part 8 Appendix C (normative) Inner cavity patency test method 10 Appendix D (Informative) Materials and Design Guidelines 11 Reference 12

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces YY/T 0977-2016 "Anesthesia and Respiratory Equipment Oropharyngeal Airway". Compared with YY/T 0977-2016, except for the In addition to structural adjustments and editorial changes, the main technical changes are as follows. a) Added legibility requirements and test methods (see 10.3.2); b) Added color coding for indicating specific specifications (see 10.3.3, 10.3.4). This document is modified to adopt ISO 5364.2016 "Anesthesia and Respiratory Equipment Oropharyngeal Airway". The technical differences between this document and ISO 5364.2016 and their reasons are as follows. ---Replaced ISO 10993-1 (see Chapter 5) with the normatively cited GB/T 16886.1 to adapt to my country's national conditions; ---Replaced ISO 11607-1 (see 9.2) with the normatively quoted GB/T 19633.1 to adapt to my country's national conditions; ---Replaced ISO 15223-1 (see 10.2) with normatively quoted YY/T 0466.1 to adapt to my country's national conditions. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116). This document was drafted by. Shanghai Medical Device Inspection and Research Institute, Henan Tuoren Medical Device Group Co., Ltd., Yadu Holding Group Co., Ltd. Co., Ltd., Medtronic (Shanghai) Management Co., Ltd. The main drafters of this document. Wang Wei, Liu Yanhong, Xu Hui, Xu Chang, Yang Xiaoqing, Zhang Jing, Wang Junxia, and Mo Yanjun. The previous versions of this document and the documents it replaces are as follows. ---It was first released as YY/T 0977-2016 in.2016, and this is the first revision.

Introduction

This document specifies the dimensions and other requirements for oropharyngeal airways. Oropharyngeal airway dimensions are indicated by length. In order to insert the oropharyngeal airway forward to the base of the tongue to prevent soft tissue from blocking the human airway, When selecting an oropharyngeal airway, its length is an important selection parameter. Oropharyngeal airway specifications are indicated with clear markings and color coding, which is very useful for quick identification and selection in emergency situations. important. Terms marked with an asterisk (*) have basic principles stated in Appendix A. The basic principles of this document are shown in Appendix A. Appendix B gives the test method for the resistance to flattening of the buccal part. Appendix C gives the test method for unblocking the inner cavity. See Appendix D for test methods, materials and design guidelines. Anesthesia and Respiratory Equipment Oropharyngeal Airways

1 Scope

This document specifies oropharyngeal airways made of plastic and/or rubber materials (including with reinforced inserts made of plastic and/or metal materials). oropharyngeal airway). This document does not specify flammability requirements for oropharyngeal airways. NOTE. The flammability of the oropharyngeal airway is a recognized hazard in applications such as those involving flammable anesthetics, electrosurgical equipment, or laser use. This is the scope of clinical management, not within the scope of this document. This document does not apply to metallic oropharyngeal airways and upper laryngeal airways without internal, integral sealing devices.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing during risk management process (GB/T 16886.1- 2022,ISO 10993-1.2018,IDT) GB/T 19633.1 Packaging of terminally sterilized medical devices Part 1.Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015,ISO 11607-1.2006,IDT) YY/T 0466.1 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1.General requirements (YY/T 0466.1-2016,ISO 15223-1.2012,IDT) YY/T 0615.1-2007 Requirements for marking "sterile" medical devices Part 1.Requirements for terminally sterilized medical devices (EN556-1.2001,IDT) isteredsymbols)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Oropharyngeal airwayoropharyngealairway A device used to maintain the passage of air through the mouth and pharynx. [Source. GB/T 4999-2003, 6.1.1, with modifications] 3.2 pharyngealend The oropharyngeal airway (3.1) is intended to be inserted into the patient's pharynx at one end. [Source. GB/T 4999-2003, 6.1.1.2, with modifications] 3.3 flangedend flangedend The flanged end of the oropharyngeal airway (3.1), intended to be external to the teeth or gums.

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