1、ANSI/AAMI/ ISO 26782: 2015 reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for estab
2、lishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a
3、 device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a r
4、ecommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to ind
5、ustrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determin
6、ing whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procu
7、rement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial re
8、presentatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice i
9、s limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-making.
10、Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rational
11、e for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices.
12、 While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular
13、product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context
14、of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when
15、it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to
16、 the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only up
17、on exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice whi
18、ch has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/ISO 26782:2015 Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1
19、-57020-608-5 Contents Page Glossary of equivalent standards iv Committee representation . v Background of ANSI/AAMI adoption of ISO 26782:2009 and ISO 26782:2009/Cor.1:2009 . vii Foreword viii Introduction . ix 1 *Scope . 1 2 Normative references 1 3 Terms and definitions 1 4 General requirements 4
20、5 Identification, marking and documents . 4 6 *Measurement range 8 7 Performance requirements . 8 8 Constructional requirements 10 9 Cleaning, sterilization and disinfection . 10 10 Biocompatibility . 11 Annex A (informative) Rationale 12 Annex B (normative) Testing accuracy, linearity and impedance
21、 of spirometers 16 Annex C (normative) * Defined test profiles . 20 Annex D (informative) Environmental aspects . 24 Annex E (informative) Reference to the essential principals 26 Bibliography . 28 Alphabetized index of defined terms used in this International Standard 29 iv 2017 Association for the
22、 Advancement of Medical Instrumentation ANSI/AAMI/ISO 26782:2015 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted
23、 by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 26782:
24、2015 v Committee representation Association for the Advancement of Medical Instrumentation Anaesthetic and Respiratory Equipment Committee The publication of ANSI/AAMI/ISO 26782 as a new American National Standard was initiated by the AAMI Anaesthetic and Respiratory Equipment Committee, which also
25、functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). At the time this document was published, the AAMI Anaesthetic and Respiratory Equipment Committee had the following members: Cochairs: Julian Goldman, Massachusetts General
26、Hospital David Carr, Teleflex Medical Members: Mark Allen, Atlas Copco David Arney, University of Pennsylvania Len Berman, Pall Medical Lee Birch, Luxfer Gas Cylinders Frank Block Steve Briol, Nonin Medical Inc William Burns, Piramal Critical Care Inc Yu Chen, Draeger Medical Systems Inc Daniel Cook
27、, Cookgas Claire Couch, Halyard Health Todd Courtney, FDA/CDRH Steven Dain, University of Western Ontario Rick Dodd, GE Healthcare Jerry Dorsch, Mayo Clinic Susan Dorsch Paul Dryden, ProMedic Inc Cindy Engelhardt, Smiths Medical David Feinstein, Beth Israel Deaconess Medical Center John Hedley-Whyte
28、, Harvard University Mike Jaffe, Cardiorespiratory Consulting LLC Bob Kopotic, CAS Medical Systems Inc Robert McCoy, Valley Inspired Products Robert McKennett, Bayhealth Medical Center Tim Morris, Medline Industries Inc Dave Osborn, Philips Electronics North America James Philip, Brigham notes and e
29、xamples: smaller roman type; description of type of document change, and test methods: italic type; TERMS DEFINED IN THIS DOCUMENT: SMALL CAPITALS. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). 2017 Association for the Advancement of Med
30、ical Instrumentation ANSI/AAMI/ISO 26782:2015 1 American National Standard ANSI/AAMI/ISO 26782:2015 b) for markings on the inside of the SPIROMETER or SPIROMETER parts, from the intended position of the person performing the related function. Check compliance for a CLEARLY LEGIBLE marking by the fol
31、lowing test. 1) Position the SPIROMETER or its part so that the viewpoint is the intended position of the OPERATOR; or the viewpoint is at any point within the base of a cone subtended by an angle of 30 to the axis normal to the centre of the plane of the marking and at a distance of 1 m. 2) Ensure
32、that the ambient illuminance is the least favourable level in the range of 100 lx to 1 500 lx. 3) Ensure that the observer has a visual acuity of 0 on the log minimum angle of resolution (log MAR) scale or 6/6 (20/20), corrected if necessary. 4) The observer correctly reads the marking from the view
33、point. 5.3 Durability of markings The markings required by 5.1 and 5.4 shall be removable only with a TOOL or by appreciable force and shall be sufficiently durable to remain CLEARLY LEGIBLE during the EXPECTED SERVICE LIFE of the SPIROMETER. In considering the durability of the markings, the effect
34、 of NORMAL USE shall be taken into account. NOTE Recordings or paper output chards are not considered markings. Check compliance by inspection and the following tests. After all the other tests of this document have been performed: a) rub markings by hand, without undue pressure, first for 15 s with
35、 a cloth rag soaked with distilled water, then for 15 s with a cloth rag soaked with methylated spirits and then for 15 s with a cloth rag soaked with isopropyl alcohol; b) test the legibility of markings to the requirements of 5.2; c) ensure that adhesive labels have not worked loose or become curl
36、ed at the edges. 6 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 26782:2015 5.4 Marking of the spirometer or its packaging 5.4.1 The SPIROMETER and, where physically possible, its ACCESSORIES shall be marked with the following: a) a symbol showing the direction of flo
37、w for any OPERATOR-detachable components that are flow-direction sensitive unless designed in such a way as to prevent incorrect use or assembly; b) the name and address or trademark and address of the MANUFACTURER; c) MODEL OR TYPE REFERENCE; d) where appropriate, an identification reference to the
38、 batch or serial number, or symbol 5.14 or 5.16 from ISO 15223-1:2007; e) method of disposal, as appropriate; f) for a SPIROMETER with an expiration date, symbol 5.12 from ISO 15223-1:2007, or if not practicable, an expiration date may be marked on the packaging. 5.4.2 The packaging of a SPIROMETER,
39、 an ACCESSORY or their components shall be marked with the following: a) details to enable the RESPONSIBLE ORGANIZATION to identify the contents of the packaging; b) the INTENDED USE of the SPIROMETER or ACCESSORY; c) for a SPIROMETER or ACCESSORY with an expiration date, symbol 5.12 from ISO 15223-
40、1:2007; d) for a single PATIENT use ACCESSORY the words “single patient use”; e) for a single use SPIROMETER, ACCESSORY or component, the words “single use only” or “do not re-use” or symbol 5.2 from ISO 15223-1:2007; f) any special storage and/or handling instructions; g) any special operating inst
41、ructions; h) any warnings and/or precautions to take; i) for a sterile SPIROMETER, ACCESSORY or component, the word “STERILE” or symbol 5.20, 5.21, 5.22, 5.23 or 5.24 (as appropriate) from ISO 15223-1:2007. Check compliance by inspection. 5.5 Instructions for use 5.5.1 General The ACCOMPANYING DOCUM
42、ENTS shall include the following: a) identity of the SPIROMETER by inclusion of the following: name or trade-name of the MANUFACTURER, and an address to which the RESPONSIBLE ORGANIZATION can refer; NOTE In some countries, the name and address of a local authorized representative is required, where
43、the MANUFACTURER does not have a local registered place of business. 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 26782:2015 7 model or type reference; b) the INTENDED USE of the SPIROMETER, including any restrictions on its use; c) a brief description of the SPIROME
44、TER, including its significant physical and performance characteristics; d) all information necessary to operate the SPIROMETER in accordance with its specification; EXAMPLE Explanations of the functions of controls, displays and signals, the sequence of operation, connection and disconnection of de
45、tachable parts and ACCESSORIES, and replacement of material that is consumed during operation. e) how the SPIROMETER functions; f) the information required in 5.4; g) a description of all markings on the SPIROMETER; EXAMPLE Figures, symbols, warning statements, abbreviations and indicator lights. h)
46、 any special operating instructions; i) any warnings and/or precautions to be taken; j) a statement that the performance of the SPIROMETER can be affected by the PATIENT spitting or coughing into the SPIROMETER during expiration or by extremes of temperature, humidity and altitude if applicable; k)
47、if installation of the SPIROMETER or its parts is required, a reference to where the installation instructions are to be found (e.g. the technical description); l) the correct method of re-assembly, if the SPIROMETER is intended to be dismantled by the OPERATOR; m) details of the SPIROMETER checks t
48、hat the OPERATOR should consider if unusual readings are obtained; n) recommended storage conditions; o) details of the nature and frequency of any maintenance and/or calibration needed to ensure that the SPIROMETER operates within the requirements specified in this International Standard; p) detail
49、s of any breathing system filter recommended; q) information concerning the disposal of the SPIROMETER, its ACCESSORIES, detachable parts and material; r) the date of issue of the ACCOMPANYING DOCUMENTS. Check compliance by inspection. 5.5.2 Cleaning, disinfection and sterilization For SPIROMETER parts or ACCESSORIES that can become contaminated through contact with the PATIENT or with body fluids or expired gases during NORMAL USE, the instructions for use shall contain: a) details about cleaning and disinfection or cleaning and sterilization methods that may be
