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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 h, 2021
- 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
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- Background of ANSI/AAMI adoption of IEC 60601-1-11:2015 as HA60601-1-11 and Amendment 1:2020
- U.S. (AAMI) Deviations from IEC 60601-1-11:2015
- Foreword
- Introduction
- INTRODUCTION to Amendment 1
- 1 Scope, object and related standards [Go to Page]
- 1.1 * Scope
- 1.2 Object
- 1.3 Related standards [Go to Page]
- 1.3.1 IEC 60601-1
- 1.3.2 Particular standards
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements [Go to Page]
- 4.1 * Additional requirements for supply mains for me equipment and me systems
- 4.2 * Environmental conditions for me equipment [Go to Page]
- 4.2.1 General
- 4.2.2 * Environmental conditions of transport and storage between uses
- 4.2.3 * Environmental operating conditions [Go to Page]
- 4.2.3.1 Continuous operating conditions
- 4.2.3.2 * Environmental shock to transit-operable me equipment
- 5 * General requirements for testing me equipment
- 6 * Classification of me equipment and me systems
- 7 Me equipment identification, marking and documents [Go to Page]
- 7.1 * Usability of the accompanying documents
- 7.2 * Additional requirements for marking of IP classification
- 7.3 Accompanying documents [Go to Page]
- 7.3.1 Contact information
- 7.3.2 Lay operator briefing information
- 7.4 Instructions for use [Go to Page]
- 7.4.1 Additional requirements for warning and safety notices
- 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
- 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
- 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 [Go to Page]
- 7.5.1 Permanently installed class i me equipment
- 7.5.2 Additional requirements for professional hygienic maintenance
- 8 Protection against excessive temperatures and other hazards [Go to Page]
- 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 [Go to Page]
- 8.3.1 * Ingress of water or particulate matter into me equipment
- 8.3.2 * Ingress of water or particulate matter into me systems
- 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 [Go to Page]
- 8.5.1 * Indication of state
- 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
- 10 Construction of me equipment [Go to Page]
- 10.1 * Additional requirements for mechanical strength [Go to Page]
- 10.1.1 General requirements for mechanical strength [Go to Page]
- Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE
- Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE
- 10.1.2 * Requirements for mechanical strength for non-transit-operable me equipment
- 10.1.3 * Requirements for mechanical strength for transit-operable me equipment
- 10.2 Additional requirements for actuating parts of controls of me equipment
- 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 [Go to Page]
- 13.1 * Additional requirement for generation of alarm signals
- 13.2 * Additional requirement for alarm signal volume
- Annex A (informative) General guidance and rationale [Go to Page]
- A.1 General guidance
- A.2 Rationale for particular clauses and subclauses [Go to Page]
- Figure A.1 – Saturation water vapour pressure as function of temperature
- Table A.1 – Saturation water vapour pressure as function of temperature
- Table A.2 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT ENCLOSURE ingress of water and particulate matter requirements
- Table A.3 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT subjected to shock and vibration
- Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems [Go to Page]
- B.1 Marking on the outside of me equipment, me systems or their parts [Go to Page]
- Table B.1 – Marking on the outside of ME EQUIPMENT , ME SYSTEMS or their parts
- B.2 Accompanying documents, general [Go to Page]
- Table B.2 – ACCOMPANYING DOCUMENTS, general
- B.3 Accompanying documents, instructions for use [Go to Page]
- Table B.3 – ACCOMPANYING DOCUMENTS, instructions for use
- B.4 Accompanying documents, technical description [Go to Page]
- Table B.4 – ACCOMPANYING DOCUMENTS, technical description
- Annex C (informative) Symbols on marking [Go to Page]
- Table C.1 – General symbols (1 of 2)
- Bibliography
- Index of defined terms used in this collateral standard [Go to Page]
