ISO 10524-3-2019 pdf free.Pressure regulators for use with medical gases一Part 3: Pressure regulators integrated with cylinder valves (VIPRs).
VIPRs shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, present no risks with an unacceptable level, under normal condition or SINGLE FAULT CONDITION, identified using risk management procedures in accordance with
Iso 14971.
The risks associated with the ignition of metallic and non-metallic materials, including the potential release of toxic products in an oxygen-enriched environment, shall be assessed according to the principles defined in ISO 15001.
The design of the VIPR should be such that in the event of internal ignition, the consequences of the ignition are contained and the gas vented safely by the VIPR.
Check compliance by inspection of the risk management file.
A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous situations can remain undetected over a period of time and as a consequence can lead to an unacceptable risk. In that case, a fault condition subsequently detected needs to be considered as a SINGLE FAULT CONDITION. Specific risk control measures to deal with such situations need to be determined within the risk management process.
5.2 Usability
The manufacturer shall address, in a usability engineering process, any risks resulting from poor usability.
Check compliance by inspection of the usability engineering file.
NOTE For information related to usability, see other standards, for example IEC 62366-1Il and IEC/
TR 62366.2121.
5.3 Materials
5.3.1 *The materials which come in contact with the medical gas in normal condition shall be resistant to corrosion and compatible with the intended medical gas and oxygen, in the temperature range specified in &L
Check compliance by inspection of the list of materials in contact with the gas in normal and SINGLE FAULT CONDITION and associated rationale for compatibility.
NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE 2 Oxygen compatibility is usually defined as the ability of a material to coexist with oxygen and a moderate ignition source. The aim of using oxygen-compatible materials is to develop a system design which has a low probability of ignition and minor consequences based on the use of materials exhibiting good compatibility and low energy release if ignited or by minimizing the quantities of non-metallic components.ISO 10524-3 pdf download.
Tags: ure regulators for use with medical gases
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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…
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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…
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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…