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BSI - BS EN 61010-2-101 + A11

Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

active, Most Current
Organization: BSI
Publication Date: 30 April 2023
Status: active
Page Count: 30
ICS Code (Electrical and electronic testing): 19.080
ICS Code (Chemical laboratories. Laboratory equipment): 71.040.10
ICS Code (Diagnostic equipment): 11.040.55

Document History

BS EN 61010-2-101 + A11
April 30, 2023
Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
A description is not available for this item.
BS EN 61010-2-101
March 31, 2017
Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
A description is not available for this item.
BS EN 61010-2-101
December 9, 2002
Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
A description is not available for this item.

References

This document references:
EN ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Published by CEN on October 1, 2011
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended...
This document references:
EN 61326-3-1 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 3-1: Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety) - General industrial applications
Published by CENELEC on July 1, 2017
This part of IEC 61326 covers all equipment within the scope of IEC 61326-1, but is limited to systems and equipment for industrial applications intended to perform safety functions as defined in IEC...
This document references:
EN 62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices
Published by CENELEC on April 1, 2015
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
EN IEC 61326-2-6 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Published by CENELEC on June 1, 2021
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL...
This document references:
EN IEC 62061 - Safety of machinery - Functional safety of safety-related control systems
Published by CENELEC on July 1, 2021
This International Standard specifies requirements and makes recommendations for the design, integration and validation of safety-related control systems (SCS) for machines. It is applicable to...
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