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YY/T 0985-2016 English PDF

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YY/T 0985-2016: Anaesthetic and respiratory equipment--Supralaryngeal airways and connectors
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YY/T 0985-2016English539 Add to Cart 5 days [Need to translate] Anaesthetic and respiratory equipment--Supralaryngeal airways and connectors Valid YY/T 0985-2016

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Basic data

Standard ID YY/T 0985-2016 (YY/T0985-2016)
Description (Translated English) Anaesthetic and respiratory equipment--Supralaryngeal airways and connectors
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 27,253
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration

YY/T 0985-2016: Anaesthetic and respiratory equipment--Supralaryngeal airways and connectors

---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.
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard Anesthesia and breathing apparatus on the throat airway and joints (ISO 11712..2009, MOD) 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I Introduction II 1 Scope 1 2 normative reference document 1 3 Terms and definitions 2 4 General requirements 3 5 * Requirements 3 5.1 Upper throat airway 3 5.2 Upper throat airway connector 5 6 requirements for sterile supply of upper throat airway and joint 5 6.1 aseptic guarantee 5 6.2 Sterile supply of upper throat airway and joint packaging 5 7 cleaning, disinfection or sterilization 5 8 mark 5 8.1 Use of symbols 5 8.2 Upper throat airway mark 5 8.3 Upper larynx airway single packing mark 6 9 random file 6 Appendix A (informative) Basic principles 8 Appendix B (normative) assesses and records the clinical manifestations of the human body Appendix C (normative) Anti - kink test 14 Appendix D (informative) Risk identification of risk assessment 18 Appendix E (informative) Materials and Design Guide 22 Reference 23

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method to modify the international standard ISO 11712..2009 "Anesthesia and respiratory equipment on the throat airway and then Head "(English version). The technical differences between this and ISO 11712..2009 and the reasons are as follows. --- on the normative reference documents, the standard made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows. Replace GB 4135 (see Chapter 3) with GB/T 4999 equivalent to the international standard ISO 4135; Replace ISO 10993-1 (see 5.1.2.1) with GB/T 16886.1 equivalent to the international standard ISO 10993-1; Replace ISO 594-1 (see 5.1.5.5) with GB/T 1962.1 equivalent to the international standard ISO 594-1; Replace ISO 5356-1 (see 5.2.1) with YY 1040.1 equivalent to the international standard ISO 5356-1; Replace ISO 11134 with the equivalent GB 18278.1 of the international standard ISO 17665-1 (see 6.1); Replace ISO 11135 with the equivalent GB 18279.1 of the international standard ISO 11135-1 (see 6.1); Replace ISO 11137-1 (see 6.1) with GB 18280.1 equivalent to the international standard ISO 11137-1; Replace ISO 11607 (see 6.2) with GB/T 19633.1 equivalent to the international standard ISO 11607-1; • Replace ISO 70 (see 8.1) with GB/T 16273.1, which is not equivalent to the international standard ISO 7000, GB/T 16273.1-2008 is redrafted according to ISO 7000..2004, all of which are selected from ISO 7000..2004. Replace ISO 14408 (see E.1.7) with equivalent YY/T 0486 using the international standard ISO 14408. - to use in the country for the purpose of adaptation, to remove the geographical restrictions in 8.1, and to change the "American English" to "Chinese". This standard compares with ISO 11712..2009 with the following editorial changes. Find Finds Finded ON Rhueither calling calling Avimes. - deleted part of the introduction in ISO 11712..2009; --- deleted appendix D.1a) 16) (repeated with D.1a) 5); --- ISO 11712..2009 The date quoted in the international standard, there are corresponding to be used as the national standard and industry standards, the Standards to use these national standards and industry standards as a normative use; - references to the international documents involved in the literature, corresponding to being adopted as national standards and industry standards, this standard with the corresponding national standard The quasi-industry standard is used as a reference. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Technical Committee on Anesthesia and Respiratory Equipment (SAC/TC116). The drafting of this standard. Shanghai Medical Devices Testing Institute, Guangzhou peacekeeping force medical equipment Co., Ltd. The main drafters of this standard. Lu E, Huang Kai-gen, Wang Wei, Xu Chang.

Introduction

* Upper laryngeal airway is a kind of entry from the mouth, not through the sound to close the throat, in order to keep the airway, which is easier With or without anesthesia gas ventilation equipment. The device should be able to provide a breathing airway and should also provide guidelines for endotracheal tube insertion. As a connection The insertion of the device at the machine end of the bronchoscope and inhalation device is also included in the standard range. * Examples of upper laryngeal airways are. laryngeal mask, throat, access and seal, with oropharyngeal oropharyngeal airway, pharyngeal airway, tracheal esophagus Sealer. The requirements of this standard are developed from the risk assessment of Hazard Identification in Appendix D. In this standard, the contents of the basic principles provided in Appendix A are identified by the * in the text. Anesthesia and breathing apparatus on the throat airway and joints

1 Scope

1.1 This standard specifies the basic requirements for the upper throat airway and fittings. The device is intended for opening and sealing the upper throat, during the self Main, auxiliary or controlled ventilation, in the patient to provide a smooth channel. 1.2 This standard specifies the type, basic characteristics, and method of design of the upper laryngeal airway. Although most of the ventilation The passages may be classified according to the specifications and dimensions (or other characteristics) specified in this standard, but this standard does not provide for a specially designed airway special requirements. 1.3 * The following medical devices are not applicable to this standard. nasopharyngeal/oropharyngeal airway, anesthesia mask, oral/nasal tracheal intubation, Device, dental appliance, tracheal stent, endotracheal tube, ventilator laryngoscope, continuous positive airway pressure breathing apparatus, esophageal sealer, probe and need to be outside Surgery placed in the equipment. 1.4 The standard requirements are dimensioned so that the operator knows which auxiliaries (such as tracheal intubation and bronchoscopy) are suitable. 1.5 * For example, if used with some flammable anesthetics, electrosurgical devices or lasers, airway flammability is a recognized risk and Not within the scope of this standard. See also E1.7.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Ruhr) Conical joints Part 1. General requirements Terminology for anesthesia and respiratory equipment GB/T 4999 GB/T 16273.1 Graphical symbols for use in equipment - Part 1. Generic symbols GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management GB 18278.1 Sterilization of health care products - Part 1. Development, validation and routine control of sterilization of medical devices Claim GB 18279.1 Sterilization of health care products Ethylene oxide - Part 1. Development, validation and routine control of sterilization of medical devices System requirements GB 18280.1 Sterilization of medical care products - Part 1. Development, validation and routine control of sterilization of medical devices Claim GB/T 19633.1 Packaging of final sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems Tracheal intubation - Part 1. Commonly used cannula and fittings YY 0337.1-2002 YY/T 0486 laser surgery for tracheal intubation signs and provide information requirements YY/T 1040.1 Anesthesia and respiratory equipment - Conical joints - Part 1. Cone and taper sleeves ISO 11990 Vision and vision equipment - Laser and laser related equipment - Laser resistance measurement of tracheal catheters (Opticsandoptical instruments- Lasersandlaser-relatedequipment-Determination oflaserresistanceoftrachealtube shafts ISO /T R11991 Guidelines for Ventilation Management in Upper Respiratory Road Surgery (Guidanceonairwaymanagementduring lasersurgeryofupperairway ISO 14155-1 Clinical study of medical devices for the human body - Part 1. General requirements (Clinicalinvestigationof

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