ISO 8536-12-2021 pdf free download.Infusion equipment for medical use Part 12: Check valves for single use.
This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.
The functional requirements in this document also apply to inline check valves.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7886-1. Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 887 1-1, Elasto,neric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates
ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2:
Identification and characterization
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.isoorgJobp
— IEC Electropedia: available at http://www.electropedia.org/
4 Designation
Designation shall follow label requirements in accordance with C1aue.9.
5 Materials
The materials used shall be chosen so that the check valves conform with the requirements specified in Clauses 6. 7 and a.
If rubber is used as a material, the requirements given in ISO 8871-1 and ISO 8871-2 shall apply.
6 Physical requirements
6.1 Particulate contamination
The check valve shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in ISO 8536-4 the number of particles shall not exceed the contamination index limit.
6.2 Leakage
The check valve, when tested in accordance with ClauscLA.2, shall show no signs of air leakage.
6.3 Iso 80369 (all parts) compatibility
Any inlet and/or outlet without a tube bond port shall have a connector as specified in the ISO 80369 series.
6.4 Counterfiow pressure resistance
The check valve shall withstand a pressure of 200 kPa in the counterl low direction when tested in accordance with Clause A.3.ISO 8536-12 pdf download.
Tags: Infusion equipment for medical use
-
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…