AAMI HA60601 1 2021

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ANSI/AAMI HA60601-1-11:2015 & A1:2021, Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Published By	Publication Date	Number of Pages
AAMI	2021	70

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Category: AAMI

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Description

This standard applies to the 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 equipment and medical electrical systems will frequently be used in locations where driving power and safety means of the electrical installation is not rel iable. The amendment addresses changes to terminology and references since the main document was finalized.

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PDF Pages	PDF Title
1	ANSI/AAMI HA60601-1-11:2015 & A1:2021 (Consolidated Text, Redline Version); Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
3	Title page
4	AAMI Standard Copyright information
5	Contents
8	Committee representation
10	Background of ANSI/AAMI adoption of IEC 60601-1-11:2015 as HA60601-1-11 and Amendment 1:2020
12	U.S. (AAMI) Deviations from IEC 60601-1-11:2015
13	Foreword
16	Introduction INTRODUCTION to Amendment 1
17	1 Scope, object and related standards 1.1 * Scope 1.2 Object 1.3 Related standards 1.3.1 IEC 60601-1
18	1.3.2 Particular standards 2 Normative references
19	3 Terms and definitions
20	4 General requirements 4.1 * Additional requirements for supply mains for me equipment and me systems
21	4.2 * Environmental conditions for me equipment 4.2.1 General 4.2.2 * Environmental conditions of transport and storage between uses
22	4.2.3 * Environmental operating conditions 4.2.3.1 Continuous operating conditions
24	4.2.3.2 * Environmental shock to transit-operable me equipment
25	5 * General requirements for testing me equipment 6 * Classification of me equipment and me systems
26	7 Me equipment identification, marking and documents 7.1 * Usability of the accompanying documents 7.2 * Additional requirements for marking of IP classification
27	7.3 Accompanying documents 7.3.1 Contact information 7.3.2 Lay operator briefing information 7.4 Instructions for use 7.4.1 Additional requirements for warning and safety notices
28	7.4.2 * Additional requirements for an electrical power source 7.4.3 Additional requirements for me equipment description 7.4.4 Additional requirements for me equipment start-up procedure
29	7.4.5 Additional requirements for operating instructions 7.4.6 Additional requirements for me equipment messages 7.4.7 * Additional requirements for cleaning, disinfection and sterilization
30	7.4.8 Additional requirements for maintenance 7.4.9 Additional requirements for environmental protection 7.4.10 Additional requirements for me equipment and me systems 7.5 Technical description 7.5.1 Permanently installed class i me equipment 7.5.2 Additional requirements for professional hygienic maintenance
31	8 Protection against excessive temperatures and other hazards 8.1 * Additional requirements for cleaning, disinfection of me equipment and me systems 8.2 * Additional requirements for sterilization of me equipment and me systems 8.3 Additional requirements for ingress of water or particulate matter into me equipment and me systems 8.3.1 * Ingress of water or particulate matter into me equipment 8.3.2 * Ingress of water or particulate matter into me systems
32	8.4 Additional requirements for interruption of the power supply/supply mains to me equipment and me system 8.5 Additional requirements for an internal electrical power source 8.5.1 * Indication of state
33	8.5.2 Accessibility of small internal electrical power sources 8.5.3 * Additional requirements for separation of parts 9 Accuracy of controls and instruments and protection against hazardous outputs
34	10 Construction of me equipment 10.1 * Additional requirements for mechanical strength 10.1.1 General requirements for mechanical strength Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE
35	Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE 10.1.2 * Requirements for mechanical strength for non-transit-operable me equipment
36	10.1.3 * Requirements for mechanical strength for transit-operable me equipment
37	10.2 Additional requirements for actuating parts of controls of me equipment
38	11 * Protection against strangulation or asphyxiation 12 Additional requirements for electromagnetic emissions of me equipment and me systems 13 Additional requirements for alarm systems of me equipment and me systems 13.1 * Additional requirement for generation of alarm signals 13.2 * Additional requirement for alarm signal volume
40	Annex A (informative) General guidance and rationale A.1 General guidance
41	A.2 Rationale for particular clauses and subclauses
45	Figure A.1 – Saturation water vapour pressure as function of temperature
46	Table A.1 – Saturation water vapour pressure as function of temperature
54	Table A.2 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT ENCLOSURE ingress of water and particulate matter requirements
56	Table A.3 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT subjected to shock and vibration
60	Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems B.1 Marking on the outside of me equipment, me systems or their parts Table B.1 – Marking on the outside of ME EQUIPMENT , ME SYSTEMS or their parts B.2 Accompanying documents, general Table B.2 – ACCOMPANYING DOCUMENTS, general
61	B.3 Accompanying documents, instructions for use Table B.3 – ACCOMPANYING DOCUMENTS, instructions for use
62	B.4 Accompanying documents, technical description Table B.4 – ACCOMPANYING DOCUMENTS, technical description
63	Annex C (informative) Symbols on marking
64	Table C.1 – General symbols (1 of 2)
66	Bibliography
68	Index of defined terms used in this collateral standard

Additional information

Standard Title	ANSI/AAMI HA60601-1-11:2015 & A1:2021, Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Published Code	AAMI
Publication Date	2021
Pages Count	70

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