ISO 7494-2-2015 pdf free.Dentistry一Dental units一Part 2: Air, water, suction and wastewater systems.
This part of Iso 7494 specifies requirements and test methods concerning
a) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the dental unit,
c) the quality for incoming water and air, and
d) the performance of dental unit suction system.
This part of ISO 7494 also specifies requirements for instructions for use and technical description.
This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this International Standard.
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 1942, Dentistry — Vocabulary
ISO 7494-1:2011, Dentistry — Dental units — Part 1: General requirements and test methods
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 10637:1999, Dental equipment — High- and medium-volume suction systems
ISO 14971, Medical devices — Application of risk management to medical devices
IEC 61672-1. Elect roacoustics — Sound level meters — Part 1: Specifications
IEC 62366, Medical devices — Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and ISO 7494-1 and the following apply.
3.1 air separator apparatus which separates liquids and solids from the suction air
3.2 bacterial filter filter designed to restrict the passage of bacteria and reduce bacteria in the procedural water or in the compressed air
3.3 backflow flow of water and/or another medium back into the external drinking water supply
3.4 backflow prevention device safety device to prevent backflow
3.5 bottled water system dental unit water system in which procedural water is supplied by an included reservoir which is not connected to an external drinking water supply system and is manually flled with incoming water or incoming solution
3.6 cannula connector component at the end of the dental suction operating hose, which joins the cannula to the operating hose
3.7 dental air compressed air supplied through the dental unit for powering, controlling, and/or assisting various
dental instruments and equipment, as well as for assisting practitioners with procedures in the oral cavity, but not for procedures requiring medical air or sterile air, such as endoscopy, oral surgery, analgesia, and life support
3.8 combination of functional items for dental use which consist, for example, of dental unit, dental patient chair, and interconnected sub-units of dental equipment and instruments providing a functional environment for dental care
3.9 dental unit suction system passive entity, including all the components from the dental unit suction source connection point through the cannula connector, which can induce air flow when connected to a suction source to evacuate solids, liquids, aerosols and gases from the oral cavity and immediate surrounding area during oral treatment procedures
3.10 dental unit suction source connection point any port on the dental unit for connection to a supply of dental suction
Tags: Dentistry
-
ISO 8600-1-2013 pdf free download.Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements. 6 Marking 6.1 Minimum marking Iach individual endoscope or endotherapy device shall have the lollowing minimum marking: a) model number and/or other mark sufficient to identify the endoscope or endotherapy device and its manufacturer; b) maximum insertion portion width, minimum instrument channel width, working length, field of view and/or direction of view where such identification is necessary for the intended use of the endoscope or endotherapy device. The Insertion portion width and instrument channel width units shall be in millimetres. The insertion portion width and instrument channel width can also be marked in French size as defined in 3.5, shown by either ‘Fr or an encircled number; c) wherever reasonable and practicable. the endoscope or endotherapy device and detachable component(s) shall be identified in terms of lot numbers or serial numbers, etc. 6.2 Marking legibility The marking shall remain legible over the lifetime of the device when the endoscope or endotherapy device is used, cleaned, disinlected, sterilized and stored in accordance with the instruction manual. 6.3 Marking exceptions When marking on the endoscope or endotherapy device or detachable component(s) is impossible to achieve due…
-
ISO 15688-2012 pdf free download.Road construction and maintenance equipment – Soil stabilizers 一 Terminology and commercial specifications. This International Standard establishes the terminology, definitions of operation and commercial specifications for soil stabilizers and their components intended for use in road construction and pavement works. It does not apply to soil stabilizers used in agricultural applications. 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 3911, Wheels and rims for pneumatic tyres — Vocabulary, designation and marking ISO 6746-1, Earth-moving machinery — Definitions of dimensions and codes — Part 1: Base machine ISO 6746-2, Earth-moving machinery — Definitions of dimensions and codes — Part 2: Equipment and attachments ISO 7134. Earth-moving machinery — Graders — Terminology and commercial specifications 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 soil stabilizer self-propelled machine, either towed or transported, with the function of pulverizing, breaking-up, aerating, homogenizing, and loosening existing and imported soil or paving materials and mixing them…
-
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…