Source: https://standards.globalspec.com/std/9893543/iec-60601-1-11-redline
Timestamp: 2019-02-18 23:19:33
Document Index: 48597593

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2']

IEC 60601-1-11 REDLINE - 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 | Engineering360
IEC 60601-1-11 REDLINE
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
ICS Code (Medical equipment): 11.040
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.
The HOME HEALTHCARE ENVIRONMENT includes:
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.
EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the professional healthcare facility environment.
NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding.
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined...
EN 13718-1 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
CSA C22.2 NO 60745-2-15 - Hand-held motor operated electric tools - Safety - Part 2-15: Particular requirements for hedge trimmers
IEC 82304-1 - Health software - Part 1: General requirements for product safety
Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated...
SNZ AS/NZS 60335.2.11 - Household and similar electrical appliances – Safety – Part 2.11: Particular requirements for tumble dryers
Published by SNZ on May 29, 2009
This clause of Part 1 is replaced by the following. This International Standard deals with the safety of electric tumble dryers intended for household and similar purposes, their rated voltage being...
SNZ AS/NZS 60335.2.90 - Household and similar electrical appliances – safety – Part 2.90: Particular requirements for commercial microwave ovens
This International Standard deals with: − the safety of microwave ovens with a cavity door intended for commercial use, their rated voltage being not more than 250 V for single-phase appliances...