YY/T 0978-2016 English PDF

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YY/T 0978-2016: Anaesthetic reservoir bags
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0978-2016	284	Add to Cart	3 days	Anaesthetic reservoir bags	Valid

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Basic data

Standard ID: YY/T 0978-2016 (YY/T0978-2016)
Description (Translated English): Anaesthetic reservoir bags
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 15,196
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 0978-2016: Anaesthetic reservoir bags

---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 reservoir bags ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard Anesthesia airbag (ISO 5362..2006, IDT) 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the translation method equivalent to ISO 5362..2006 "Anesthesia storage airbag". 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 by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This standard drafting unit. Shandong Province medical equipment product quality inspection center. The main drafters of this standard. Wu Ping, Wan Min, Zhang Bo, Wang Jinhong.

Introduction

This standard belongs to the standard of respiratory anesthesia equipment, this standard mainly involves anesthesia capsule capsule design, specification and expansion of the airbag The required stress resistance. It is widely accepted that the airbag is required to be electrically conductive when used in combination with a flammable anesthetic. Especially when provided between It is particularly important that the airbag is electrically conductive when the positive pressure ventilation is compressed by the anesthetic supplier. This standard gives the requirements for antistatic and non-antistatic airbags. When using flammable anesthetics, use only antistatic airbags. The test method given in Appendix E, due to the test to fill the capsule with water, is not suitable for routine use and production control, therefore, Appendix F An alternative test method for the replacement of water with air is given in the form of an informative appendix. If this method shows the end of the method with Appendix E Fruit equivalent, but also as an arbitration test method. Gas leak tests with air rather than water are given only in Appendix A as an informative appendix. Appendix G gives the material to the material Suggest. Anesthesia airbag

1 Scope

This standard specifies the requirements for antistatic and non-antistatic airbags for anesthesia or pulmonary ventilation systems. This standard includes a capsule Specifications, anti-expansion and electrical resistance (when applicable). This standard covers the requirements for disposable and repetitive use of airbags. Repetitive use of the airbag is expected in the recommended use of life Life within the requirements of this standard. This standard does not apply to special purpose air bags, such as automatic expansion of the capsule. The capsule used with the anesthetic gas removal system is not considered to be Anesthesia airbag, and therefore not within the scope of this standard.

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 3505 Product Geometry Technical Specifications (GPS) Surface Structure Contours Terminology, Definitions and Surface Structure Parameters (GB/T 3505-2009, ISO 4287..1997, IDT) GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IDT, IEC 60601-1. 1988) GB/T 19633.1 Final sterilization of medical device packaging - 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 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements (YY 0466.1-2009, ISO 15223-1..2007, IDT) YY/T 0615.1-2007 Requirements for "sterile" medical devices Part 1. Requirements for final sterilization of medical devices (IDT, EN556-1..2001) YY/T 1040.1 Anesthesia and respiratory equipment - Conical joints - Part 1. Cone and taper sleeves (YY 1040.1-2003, ISO 5356-1..1996, IDT)

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Anesthesia airbag anaestheticreservoirbag As a soft capsule container of respiratory system components. 3.2 Combination of neck assembledneck A neck with a adapter. 3.3 Conversion adapter A dedicated connector is connected between the totally mismatched components, one end of which is expected to be inserted into the neck of the bladder and one at the other end Conforms to YY/T 1040.1. ......

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