BS ISO 11197:2016 pdf free.Medical supply units.
IEC 60601-1:2005.A1:2012, 1.4 applies with cue following additions:
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 6060 1- 1:2005+A1:2012 with the prefix “201” (e.g. 201.1 in this standard addresses the content of IEC 60601-
1:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix 20x where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of IEC 60601-1:2005+A1:2012 are specified by the use of the following words:
‘Replacement means that the clause or subclause of IEC 6060 l-1:2005+A1:2012 or applicable collateral standard is replaced completely by the text of this particular standard.
Addition” means that the text of this particular standard is additional to the requirements of IEC 60601-1:2005+A1:2012 or applicable collateral standard.
AmendmentN means that the clause or subclause of IEC6O6OI-1:2005+A1:2012 or applicable collateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of IEC 60601-1:2005+A1:2012 are numbered starting from 201.10 1. Additional Annexes are lettered AA, RB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x is the number of the collateral standard, e.g. 202 for IEC 6060 1-1-2, 203 for IEC 60601-1-3. etc.
The term “this standard is used to make reference to IEC 60601-1:2005+A1:2012, any applicable collateral standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of IEC 60601-1:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601-1:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
201.2 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.
NOTE Informative references are listed in the Bibliography on page 25.BS ISO 11197 pdf free download.
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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…