YY/T 0978-2016Anaesthetic reservoir bags (English PDF)
麻醉储气囊
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 0978-2016 is the English-translated version of 麻醉储气囊.
YY/T 0978-2016 is the Chinese standard "Anaesthetic reservoir bags". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY/T 0978-2016
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
Contents
- Foreword
- Introduction
- 1 Scope
- 2 normative reference documents
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 3505Geometrical product specifications (GPS) -- Surface texture: Profile method -- Terms, definitions and surface texture parameters
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 19633.1Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- YY/T 0615.1-2007Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
- YY/T 1040.1Anaesthetic and respiratory equipment—Conical connectors - Part 1: Cones and sockets
ISO 5356-1
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Related Standards
GB/T 19633.1-2024 — Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/T 3505-2009 — Geometrical product specifications (GPS) -- Surface texture: Profile method -- Terms, definitions and surface texture parameters
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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