ISO 10079-3-2014 pdf free.Medical suction equipment 一 Part 3: Suction equipment powered from a vacuum or positive pressure gas source.
This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
The equipment can be stand-alone or part of an integrated system.
Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079.
This part of ISO 10079 does not apply to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;
b) end-piece such as suction catheters, Yankauer sucker and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
1) laboratory suction;
g) autotransfusion systems;
h) closed systems for wound drainage;
i) mucus extractors, including neonatal mucus extractors;
j) ventouse (obstetric) equipment;
k) breast pumps;
I) liposuction;
m) uterine aspiration;
n) plume evacuation systems.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Iso 3744, Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets iSO 5359, Anaesthetic and respiratory equipment – Low-pressure hose assemblies for use with medical gases iSO 70001), Graphical symbols for use on equipment — Registered symbols
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 80369 (all parts), Small-bore connectors for liquids and gases in healthcare applications I EC 60601-1: 2005+A 1:2012, Medical electrical equipment — Part 1: General requirements for safety
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability
IEC 61672-1, Elect roacoustics — Sound level meters — Part 1: Specifications IEC 62366, Medical devices — Application of usability engineering to medical devices EN 1041, Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 collection container container in which liquids and solid particles are collected
3.2 collection container assembly collection container and its closure with connectors for suction
3.3 drainage removal of liquid, solid particles or gas from body cavity or wound.ISO 10079-3 pdf free download.
Tags: Medical suction equipment
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ISO 18436-1-2012 pdf free.Condition monitoring and diagnostics of machines – Requirements for qualification and assessment of personnel一 Part 1: Requirements for assessment bodies and the assessment process. 5 Requirements for assessment body personnel 5.1 General provisions In order to ensure that the assessment process is carried out effectively and uniformly, the competence requirements for personnel involved in the entire process shall be defined by the assessment body and, in the case of a third party, be approved by the responsible TCC (in accordance with ISO/IEC 17024). The assessment body shall require its personnel (internal or external) to sign a contract, or other document, by which they commit themselves to comply with the rules defined by the assessment body, including those relating to confidentiality and those relating to independence from commercial and other interests, and from any prior or present link with the persons to be examined that would, in the opinion of the interested parties, compromise impartiality. Clearly documented instructions shall be available to the personnel, describing their duties and responsibilities. These instructions shall be maintained up to date. All personnel involved in any aspect of assessment activities shall possess appropriate educational qualifications, experience and technical expertise, which satisfy defined…