EN ISO 14630-2012 pdf free download.Non-active surgical implants – General requirements (ISO 14630:2012).
EN ISO 14630 specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional tests are given or referred to in level 2 and level 3 standards.
NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485. might be appropriate to help ensure that the implant achieves its intended performance.
2 Normative references
The following referenced documents are indispensable for the application 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 8601, Data elements and interchange formats — information interchange — Representation of dates and times
ISO 10993-1. Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validatiOn and routine control of a sterilization process for medical devices.EN ISO 14630 pdf download.
Tags: Non-active surgical implants
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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…