ANSI AAMI 7199-2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).pdf

1、ANSI/AAMI/ISO 7199: 2016Cardiovascular implants and artificial organsBlood-gas exchangers (oxygenators)American National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended prac

2、tice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care,

3、and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are

4、avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used

5、 to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, w

6、arnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporti

7、ng; 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 establishing the criteria mu

8、st 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 device is used safely

9、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 recommended practice is

10、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 industrial personnel on su

11、ch 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 determining whether an AAMI sta

12、ndard 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 procurement authorities). Th

13、e 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 representatives, whose wo

14、rk 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 is limited, however, in

15、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. Despite periodic review

16、 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 rationale for each of its provi

17、sions. 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. While observed or pote

18、ntial 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 product as “unsafe“. A

19、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 of the specific needs a

20、nd 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 it is used in conjuncti

21、on 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 the AAMI Vice Presiden

22、t, 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 upon exhaustion of any ap

23、peals 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 which has not been develop

24、ed 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 7199:2016 (Revision of ANSI/AAMI/ISO 7199:2009/(R)2014 Fax: +1-703-276-0793. Printed in the United States

25、of America ISBN 978-1-57020-655-9 Contents PageGlossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 7199:2016 . vi Foreword . vii Introduction . viii 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Requirements . 4 5 Tests and measurement

26、s to determine compliance with this document . 5 7 Packaging . 13 Bibliography . 14 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 7199:2016 Glossary of equivalent standards International Standards adopted in the United States may include normative references to oth

27、er International Standards. AAMI maintains a current list of each International Standard that has been adopted 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.o

28、rg/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 7199:2016 v Committee representation Association for the Advancement of Medical Instrumentation Blood/Gas Exchange Device Committee The adoption of ISO 7199:2016 as an American National Standard w

29、as initiated by the AAMI Blood/Gas Exchange Device Committee. The AAMI Blood/Gas Exchange Device Committee also functions as the U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Blood/Gas Exchange Devic

30、e Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4) played an active part in developing the ISO standard. At the time this document was published, the AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4) had the following members: Cochairs: Trevor Huang, PhD MBA Mark Kuru

31、sz, CCP Members: Richard Chan, CCP, Northshore University Hospital Drew Holmes, Baxter Healthcare Tsuyoshi Hosoi, Terumo Cardiovascular Systems Trevor Huang, PhD MBA, Medtronic Perfusion Systems Mark Kurusz, CCP, Austin, Texas George Silvay, MD PhD, Mount Sinai Medical Center Catherine Wentz, FDA/CD

32、RH Alternates: David M. Fallen, CCP, Terumo Medical Qijin Lu, FDA/CDRH Rakesh Sethi, Medtronic NOTE Participation by federal agency representatives in the development of this standard does not constitute endorsement by the federal government or any of its agencies. vi 2017 Association for the Advanc

33、ement of Medical Instrumentation ANSI/AAMI/ISO 7199:2016 Background of AAMI adoption of ISO 7199:2016 As indicated in the foreword to the main body of this document (page vii), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United

34、 States is one of the ISO members that took an active role in the development of this standard, which was developed by ISO Technical Committee (TC) 150 Subcommittee (SC) 2, Cardiovascular implants and extracorporeal systems, to ensure that medical grade tubing in single-use tubing packs for the tran

35、sfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) is adequately tested for both safety and function. U.S. participation in this ISO SC is organized through the U.S. Technical Advisory Group for ISO/TC 150/SC 2, administered by th

36、e Association for the Advancement of Medical Instrumentation (AAMI). AAMI encourages its committees to harmonize their work with international standards as much as possible. The U.S. adoption of ANSI/AAMI/ISO 7199:2016 was approved by the American National Standards Institute (ANSI) on 6 December 20

37、16. The AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4, Blood/gas exchangers) initiated the U.S. adoption of ISO 7199:2016. AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that

38、may have occurred since publication. AAMI (and ANSI) have adopted other ISO standards. See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI which gives the corresponding U.S. designation and the level of equivalency with the ISO standard. As used within the context of

39、 this document, “shall” indicates requirements strictly to be followed to conform to the standard. “Should” indicates that among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessa

40、rily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited. “May” is used to indicate that a course of action is permissible within the limits of the standard. “Can” is used as a statement of possibility and capability. Finally, “m

41、ust” is used only to describe “unavoidable” situations, including those mandated by government regulation. NOTE Users of this standard are advised that this document is an AAMI identical adoption of an ISO document and that the following international conventions have been carried over to the AAMI p

42、ublication: British English spelling (e.g. colour instead of color) Use of SI units (e.g. metres instead of feet, Celsius instead of Fahrenheit, etc.) Decimal comma instead of a decimal point (e.g. 1 000,15 instead of 1,000.15) The concepts incorporated in this standard should not be considered infl

43、exible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological developments. To remain relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this standard are invit

44、ed. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. NOTE Beginning with the ISO foreword on page vii, this American National Standard is identical to ISO 7199:2016. 2017 Association for the Advancement of Medi

45、cal Instrumentation ANSI/AAMI/ISO 7199:2016 vii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each m

46、ember body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

47、Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different ty

48、pes of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held

49、 responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in t