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NEN-EN-IEC 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: NEN
Publication Date: 1 November 2022
Status: active
Page Count: 20
ICS Code (Electrical and electronic testing): 19.080
ICS Code (Diagnostic equipment): 11.040.55

Document History

NEN-EN-IEC 61010-2-101
November 1, 2022
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
Equipment included in scope This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical...
NEN-EN-IEC 61010-2-101/A11
November 1, 2022
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.
NEN-EN-IEC 61010-2-101
March 1, 2017
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
NEN-EN- IEC 61010-2-101 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in...
NEN-EN-IEC 61010-2-101
December 1, 2002
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

References

This document references:
EN ISO 13849-1 - Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design
Published by CEN on May 1, 2023
This document specifies a methodology and provides related requirements, recommendations and guidance for the design and integration of safety‐related parts of control systems (SRP/CS) that perform...
This document references:
EN ISO 13850 - Safety of machinery - Emergency stop function - Principles for design
Published by CEN on November 1, 2015
This International Standard specifies functional requirements and design principles for the emergency stop function on machinery, independent of the type of energy used. It does not deal with...
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:
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...
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:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
18113-5 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Published by ISO on October 1, 2022
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and...
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