1、American National StandardANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)MEDICAL ELECTRICAL EQUIPMENT Part 1-11:General requirements for basic safety and essentialperformance Collateral Standard: Requirements formedical electrical equipment and medical electricalsystems used in the home healt
2、hcare environmentObjectives 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 practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mis
3、sion: 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, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can con
4、tribute 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 avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be
5、 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 to determine whether the device conforms with the safety and performance criteria and/or to compare the perform
6、ance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the devic
7、e in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting commi
8、ttee 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 must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processi
9、ng 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 and effectively and that its performance will be maintained. Although a device standard is primarily directed to
10、 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 usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding
11、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 such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engi
12、neering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several imp
13、ortant concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of
14、 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 work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied
15、 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 the sense that it responds generally to perceived risks and conditions that may not always be relevant to specif
16、ic 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 and revision (at least once every five years), a standard or recommended practice is necessarily a static docum
17、ent 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 provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particul
18、ar 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 potential risks with existing equipment typically form the basis for the safety and performance criteria defined in
19、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 voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must
20、 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 and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and rec
21、ommended 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 conjunction with other sources of information and policy guidance and in the context of professional experience and judgm
22、ent. 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 President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originatin
23、g 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 appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The
24、Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an o
25、fficial interpretation in the AAMI News. American National Standard ANSI/AAMI HA60601-1-11:2015 (Revision of ANSI/AAMI HA60601-1-11:2011) (IEC 60601-1-11:2015, MOD) MEDICAL ELECTRICAL EQUIPMENT Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requiremen
26、ts for medical electrical equipment and medical electrical systems used in the home healthcare environment Approved 7 August 2015 by Association for the Advancement of Medical Instrumentation Approved 25 August 2015 by American National Standards Institute, Inc. Abstract: This standard applies to th
27、e safety and essential performance of medical electrical equipment and medical electrical systems, which are intended by the manufacturer for use in home care applications usually without continual professional supervision and temporarily in the clinical environment. These medical electrical equipme
28、nt and medical electrical systems will frequently be used in locations where driving power and safety means of the electrical installation is not reliable. These medical electrical equipment and medical electrical systems will often be supervised by non-healthcare personnel with different levels of
29、training. Keywords: medical electrical equipment, safety, home care, home usePublished by Association for the Advancement of Medical Instrumentation 4301 N Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2015 by the Association for the Advancement of Medical Instrumentation All Rights
30、 Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under fede
31、ral law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and dama
32、ges of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-593-0 Contents Glossary of e
33、quivalent standards vii Committee representation .viii Background of ANSI/AAMI adoption of IEC 60601-1-11:2015 x Foreword . xi U.S. Deviations to IEC 60601-1-11:2015 xiv Introduction xv 1 Scope, object and related standards 1 1.1 * Scope . 11.2 Object . 1 1.3 Related standards 1 IEC 60601-1 1 1.3.1P
34、articular standards . 2 1.3.22 Normative references 2 3 Terms and definitions 3 4 General requirements 4 4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 44.2 * Environmental conditions for ME EQUIPMENT 4General . 4 4.2.1* Environmental conditions of transport and sto
35、rage between uses . 44.2.2* Environmental operating conditions 54.2.35 * General requirements for testing ME EQUIPMENT . 7 6 * Classification of ME EQUIPMENT and ME SYSTEMS . 8 7 ME EQUIPMENT identification, marking and documents . 9 7.1 * USABILITY of the ACCOMPANYING DOCUMENTS . 97.2 * Additional
36、requirements for marking of IP classification 97.3 ACCOMPANYING DOCUMENTS . 9 Contact information 9 7.3.1LAY OPERATOR briefing information 9 7.3.27.4 Instructions for use 10 Additional requirements for warning and safety notices . 10 7.4.1* Additional requirements for an electrical power source . 10
37、7.4.2Additional requirements for ME EQUIPMENT description . 10 7.4.3Additional requirements for ME EQUIPMENT start-up PROCEDURE 11 7.4.4Additional requirements for operating instructions . 11 7.4.5Additional requirements for ME EQUIPMENT messages 11 7.4.6* Additional requirements for cleaning, disin
38、fection and sterilization 117.4.7Additional requirements for maintenance 12 7.4.8Additional requirements for environmental protection 12 7.4.9Additional requirements for ME EQUIPMENT and ME SYSTEMS 12 7.4.107.5 Technical description . 12 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT . 12 7.5.1Additiona
39、l requirements for professional hygienic maintenance . 13 7.5.28 Protection against excessive temperatures and other HAZARDS . 13 8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and ME SYSTEMS 13 8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS
40、. 13 8.3 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS 13 * Ingress of water or particulate matter into ME EQUIPMENT . 13 8.3.1* Ingress of water or particulate matter into ME SYSTEMS 13 8.3.28.4 Additional requirements for interruption of the po
41、wer supply/SUPPLY MAINS to ME EQUIPMENT and ME SYSTEM . 14 8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE . 14 * Indication of state 14 8.5.1Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs 15 8.5.29 Accuracy of controls and instruments and protection against hazardous o
42、utputs. 15 10 Construction of ME EQUIPMENT 15 10.1 * Additional requirements for mechanical strength 15 General requirements for mechanical strength 15 10.1.1* Requirements for mechanical strength for non-TRANSIT-OPERABLE ME EQUIPMENT 17 10.1.2* Requirements for mechanical strength for TRANSIT-OPERA
43、BLE ME EQUIPMENT . 18 10.1.310.2 Additional requirements for actuating parts of controls of ME EQUIPMENT 19 11 * Protection against strangulation or asphyxiation 20 12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and ME SYSTEMS 20 13 Additional requirements for ALARM SYSTEMS
44、 of ME EQUIPMENT and ME SYSTEMS 20 13.1 * Additional requirement for generation of ALARM SIGNALS 20 13.2 * Additional requirement for ALARM SIGNAL volume . 20 Annex A (informative) General guidance and rationale 21 A.1 General guidance 21 A.2 Rationale for particular clauses and subclauses . 22 Anne
45、x B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 39 B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 39 B.2 ACCOMPANYING DOCUMENTS, general 39 B.3 ACCOMPANYING DOCUMENTS, instructions for use 40 B.4 ACCOMPANYING DOCUMENTS, technical
46、 description 41 Annex C (informative) Symbols on marking . 42 Bibliography 44 Index of defined terms used in this collateral standard . 46 Figure 1 Small finger probe 5.6 . 8 Figure A.1 Saturation water vapor pressure as function of temperature . 25 Table 1 Mechanical strength test applicability, no
47、n-TRANSIT-OPERABLE . 16 Table 2 Mechanical strength test applicability, TRANSIT-OPERABLE 17 Table A.1 Saturation water vapor pressure as function of temperature 26 Table A.2 Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT ENCLOSURE ingress of water and particulate matter requirements . 34
48、 Table A.3 Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT subjected to shock and vibration . 35 Table B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts 39 Table B.2 ACCOMPANYING DOCUMENTS, general . 39 Table B.3 ACCOMPANYING DOCUMENTS, instructions for use . 4
49、0 Table B.4 ACCOMPANYING DOCUMENTS, technical description . 41 Table C.1 General symbols 42 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI HA60601-1-11:2015 vii 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 by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level
