BS EN IEC 61010-2-101:2022+A11:2022 PDF

Scope: 1 Scope and object This clause of Part 1 is applicable except as follows: 1.1.1 General Replacement: Replace the text, except the first paragraph, with the following new text: This part of IEC 61010 provides particular safety requirements to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It is intended to be used in conjunction with the manufacturer’s risk management but not to replace it. NOTE 1 A good design practice of an equipment starts from the beginning with a risk management process according to ISO 14971, which provides requirement and guidance for a comprehensive risk management process and identifies hazards and risks related with the equipment. IVD medical equipment, whether used alone or in combination, is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning one or more of the following: • a physiological or pathological state; or ...

BS EN IEC 61010-2-101:2022+A11:2022 Referenced Document

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 applic
EN 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
EN IEC 62061:2021 Safety of machinery - Functional safety of safety-related control systems
EN ISO 13849-1:2015 Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design (ISO 13849-1:2015)
EN ISO 13850 Safety of machinery - Emergency stop function - Principles for design
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 18113-5 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

2023 BS EN IEC 61010-2-101:2022+A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Safety requirements for in vitro diagnostic (IVD) medical equipment