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YY/T 0985-2016Anaesthetic and respiratory equipment-Supralaryngeal airways and connectors (English PDF)

麻醉和呼吸设备上喉部通气道和接头

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 0985-2016 is the English-translated version of 麻醉和呼吸设备上喉部通气道和接头.

YY/T 0985-2016 is the Chinese standard "Anaesthetic and respiratory equipment-Supralaryngeal airways and connectors". Its scope clause reads: 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.

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.

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.

The standard requirements are dimensioned so that the operator knows which auxiliaries (such as tracheal intubation and bronchoscopy) are suitable. Not within the scope of this standard. See also E1.7. Its clauses include normative reference documents.

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Document preview — YY/T 0985-2016

National Standard of the People's Republic of China

ICS: 11.040.10
Classification: C 46

Issued by: National Medical Products Administration of the People's Republic of China

Preface
Introduction
1 Scope
2 normative reference document
3 Terms and definitions
4 General requirements
5 * Requirements
5.1 Upper throat airway
5.2 Upper throat airway connector
6 requirements for sterile supply of upper throat airway and joint
6.1 aseptic guarantee
6.2 Sterile supply of upper throat airway and joint packaging
7 cleaning, disinfection or sterilization
8 mark
8.1 Use of symbols
8.2 Upper throat airway mark
8.3 Upper larynx airway single packing mark
9 random file
Appendix A (informative) Basic principles
Appendix B (normative) assesses and records the clinical manifestations of the human body
Appendix C (normative) Anti - kink test
Appendix D (informative) Risk identification of risk assessment
Appendix E (informative) Materials and Design Guide

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.

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.

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 […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 11990 · ISO 14155-1

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