ANSI AAMI ISO 5367 pdf free download

ANSI AAMI ISO 5367 pdf free download.Anaesthetic and respiratory equipment — Breathing sets and connectors.
6 Prevention of electrostatic charges * Antistatic breathing tubes and securely attached components that are for use with flammable anaesthetic mixtures shall have an end-to-end electrical resistance of not less than 1 megaohm (1 MΩ) and not more than 1 000 megaohm (1 000 MΩ) when tested in accordance with the requirements of IEC 60601 -1 :2005, Annex G. 7 Requirements for breathing sets and breathing tubes supplied sterile 7.1 Sterility assurance Breathing sets and breathing tubes supplied and marked “STERILE” shall satisfy the requirements of subclause 4.1 of EN 556-1 :2001 . 7.2 Packaging of breathing sets and breathing tubes supplied sterile 7.2.1 Breathing sets and breathing tubes supplied and marked “STERILE” shall be contained in an individual pack. 7.2.2 The pack shall serve as an effective barrier to the penetration of microorganisms and particulate matter in accordance with ISO 11 607-1 . 7.2.3 The pack shall not permit reclosure without clearly revealing that it has been opened. 8 Marking 8.1 General a) If required by a local competent authority, breathing sets and breathing tubes, unit packs, shelf or multi-unit packs, and information to be supplied by the manufacturer shall comply with EN 1 041 . b) The requirements of 8.2 and 8.3 may be met by use of the appropriate symbols as given in ISO 7000 and ISO 1 5223-1 . 8.2 Marking of breathing sets and breathing tubes Breathing sets and breathing tubes intended for cleaning, reprocessing, and disinfection prior to reuse shall be legibly and durably marked with the following information:NOTE 1 Marking is required on tubes intended for cleaning, reprocessing and disinfection prior to reuse because this information is often lost after the first use. a) the name and/or trademark of the manufacturer and/or supplier; b) the batch number and, if required by a local competent authority, for devices placed on the market within the European Community, preceded by the word “LOT”; c) for breathing sets and breathing tubes and securely attached non-metallic components made of antistatic materials, the word “ANTISTATIC”; NOTE 2 They may also bear a continuous indelible yellow-coloured marking throughout their length. d) for breathing sets and breathing tubes that are used with flammable anaesthetic mixtures with air, the characters “AP” (symbol IEC 6041 7-5331 ) in a prominent location; e) for breathing sets and breathing tubes that are used with flammable anaesthetic mixtures with oxygen/nitrous oxide, the characters “APG” (symbol IEC 60417-5332) in a prominent location. 8.3 Marking of packages Packages containing breathing sets and breathing tubes intended for single use shall be marked with the information given in 8.2. NOTE 1 This information is made available at the point of care. NOTE 2 Manufacturers’ attention is drawn to the regulatory provision requiring that the indication of single use must be consistent across the European Community. *Packages shall additionally be clearly marked with the following: a) the word “STERILE” or the symbol (ISO 7000-2499), if appropriate (the words or the symbol should also indicate the method of sterilization chosen); b) the words “single use” or the symbol (ISO 7000-1 051 ), if appropriate; NOTE 3 Manufacturers’ attention is drawn to the regulatory provision requiring that the indication of single use must be consistent across the European Community.ANSI AAMI ISO 5367 pdf download.